<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03837496</url>
  </required_header>
  <id_info>
    <org_study_id>18-603</org_study_id>
    <secondary_id>K07CA211107</secondary_id>
    <nct_id>NCT03837496</nct_id>
  </id_info>
  <brief_title>Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors</brief_title>
  <acronym>STRIDE</acronym>
  <official_title>Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the feasibility and acceptability of a brief,&#xD;
      virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking&#xD;
      hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal&#xD;
      therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The majority of breast cancer is hormone sensitive and treated with 10 years of&#xD;
      adjuvant endocrine therapy (AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of&#xD;
      recurrence and improve survival; however, adherence to AET among breast cancer survivors&#xD;
      (BCS) is a challenge, with half of women becoming non-adherent within five years. Difficulty&#xD;
      coping with symptoms (e.g., sleep problems, hot flashes, weight gain, fatigue) and&#xD;
      psychosocial distress (i.e., depression or anxiety symptoms), and other emotional and&#xD;
      logistical factors are major barriers to adherence. There is a dearth of efficacious&#xD;
      interventions targeting the needs and adherence challenges of BCS prescribed AET.&#xD;
&#xD;
      Objective: To address this gap, the proposed study, funded by the National Cancer Institute,&#xD;
      employs a mixed-methods design to develop and test an evidence-based intervention (STRIDE) to&#xD;
      enhance adherence to AET, improve symptom management, and reduce distress in breast cancer&#xD;
      survivors.&#xD;
&#xD;
      Specific Aims: The primary aims of this study are: 1) to examine the feasibility and&#xD;
      acceptability of a tailored, small-group, virtual intervention (STRIDE) compared to a&#xD;
      medication monitoring control for survivors of breast cancer taking AET, and 2) to explore&#xD;
      the effects of the STRIDE intervention on adherence to AET, symptom distress, and&#xD;
      satisfaction with AET.&#xD;
&#xD;
      Study Design: Phase 1 included (1) semi-structured interviews with BCS on AET (n=30) and&#xD;
      intervention development with psychologists and oncology clinicians. The intervention is a a&#xD;
      brief, virtual, small-group, cognitive-behavioral intervention that aims to alleviate&#xD;
      symptoms and side effects related to hormonal therapy or breast cancer, optimize&#xD;
      medication-taking, and reduce emotional distress for breast cancer survivors taking hormonal&#xD;
      therapy. Phase 2 will entail a run-in phase (n=5) to evaluate acceptability and further&#xD;
      refine the intervention, followed by a randomized controlled pilot trial (n=100) to assess&#xD;
      the feasibility of comparing the STRIDE intervention to a medication monitoring control with&#xD;
      assessments and adherence monitoring over the course of six months. Participants will be&#xD;
      recruited at Massachusetts General Hospital Cancer Center and three community satellite&#xD;
      sites. Eligible participants will be hormone-receptor positive breast cancer survivors&#xD;
      prescribed AET who are experiencing distress related to AET (e.g., adherence difficulties,&#xD;
      side effects, etc.). This research study involves completing 3 questionnaire batteries at the&#xD;
      time of enrollment, 12 weeks, and 24 weeks. The participant will also be asked to store their&#xD;
      hormonal therapy pills in a medication bottle provided by the study team throughout the 24&#xD;
      week study period. If the participants are randomized to receive the STRIDE intervention, the&#xD;
      participant will have six weekly one-hour virtual (videoconferencing) sessions in small&#xD;
      groups with a trained clinician followed by two 15-minute check-in phone calls later in the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 28, 2019</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 17, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor will be blinded to the participant's study condition</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility and Acceptability</measure>
    <time_frame>12 weeks</time_frame>
    <description>The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate &gt; 50%), retention (follow-up assessment completion rate &gt; 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions [67%]).&#xD;
The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if &gt;75% of participants report average satisfaction scores greater than the CSQ's mid-point. The CSQ is scored on a four-point Likert scale with higher scores indicating higher satisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period</measure>
    <time_frame>Mean medication adherence rates over 24 weeks</time_frame>
    <description>Medication Event Monitoring System (MEMS Caps): Participants will store medication in the MEMS bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the 24-week study period between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline</measure>
    <time_frame>Baseline, and post-intervention at 12-weeks post-baseline</time_frame>
    <description>Medication Adherence Report Scale (MARS-5): Changes in self-reported adherence to adjuvant endocrine therapy between groups will be explored using the MARS-5 at 3-months post-baseline. The MARS-5 assesses adherence to treatment and has been used specifically in the context of AET adherence. The scale consists of five items that ask about suboptimal adherence behaviors, such as &quot;I stop taking my adjuvant endocrine therapy medicine for a while.&quot; Each item is answered on a scale of 1 (Always) to 5 (Never). Scores range from 5 to 25 points with scores less than 25 defined as low adherence to the medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.</measure>
    <time_frame>Baseline, and post-intervention at 12-weeks post-baseline</time_frame>
    <description>Cancer Therapy Satisfaction Questionnaire (CTSQ): Changes in self-reported satisfaction with AET will be explored between groups at 12 weeks post-baseline with the Cancer Therapy Satisfaction Questionnaire (CTSQ). The CTSQ is a previously published 21-item measure that evaluates patients' beliefs about the following aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for non-adherence. We used the satisfaction with cancer therapy subscale. Each item is scored on a scale of 1 (&quot;Never&quot; or &quot;Very inconvenient&quot;) to 5 (&quot;Always&quot; or Very Convenient&quot;). A greater score on this measure indicates greater patient cancer therapy satisfaction. Scores can range from a minimum of 0 to a maximum of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline</measure>
    <time_frame>Baseline and post-intervention at 12 weeks post-baseline</time_frame>
    <description>Breast Cancer Prevention Trial Symptom Scale (BCPT): The investigators will examine changes in self-reported symptom distress on the BCPT between groups at 12 weeks post-baseline. The BCPT is a symptom checklist used to document physical and psychological symptoms associated with ET use. The measure includes several clinically-relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Adherence, Medication</condition>
  <arm_group>
    <arm_group_label>STRIDE Run-In</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stride is delivered as a Five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment and 3-months post- enrollment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STRIDE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medication Monitoring Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medication monitoring plus standard care&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>STRIDE</intervention_name>
    <description>STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.</description>
    <arm_group_label>STRIDE</arm_group_label>
    <arm_group_label>STRIDE Run-In</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medication Monitoring Control</intervention_name>
    <description>Care provided as standard by the hospital and medication monitoring</description>
    <arm_group_label>Medication Monitoring Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age 21 or older&#xD;
&#xD;
          -  Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer&#xD;
&#xD;
          -  Within 1 week-36 months of starting adjuvant endocrine therapy&#xD;
&#xD;
          -  Ability to read and respond in English&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2&#xD;
&#xD;
          -  Currently taking adjuvant endocrine therapy (i.e. if took recent break, has taken&#xD;
             within the past 2 weeks)&#xD;
&#xD;
          -  Completed primary treatment (i.e., chemotherapy, surgery, and/or radiation) for&#xD;
             early-stage breast cancer&#xD;
&#xD;
          -  Indicates a score ≥4 on one of the three NCCN adapted distress thermometer study&#xD;
             screening questions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization&#xD;
             within the past year&#xD;
&#xD;
          -  Cognitive impairment that prohibits participation in the study&#xD;
&#xD;
          -  Enrollment in a different clinical trial for breast cancer&#xD;
&#xD;
          -  Current participation in formal group psychotherapy or other psychosocial intervention&#xD;
             trial&#xD;
&#xD;
          -  Undergoing primary treatment for other cancer (i.e., advanced stage cancer)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jamie M. Jacobs, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <results_first_submitted>August 15, 2022</results_first_submitted>
  <results_first_submitted_qc>November 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 18, 2022</results_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Jamie Jacobs</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Endocrine Therapy</keyword>
  <keyword>Hormonal Therapy</keyword>
  <keyword>Symptoms</keyword>
  <keyword>Distress</keyword>
  <keyword>Survivors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>BCH - Contact the Technology &amp; Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 3, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03837496/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study recruitment paused due to the COVID-19 pandemic from mid-March 2020 through May of 2020. Run-in participants were not enrolled as part of the randomized controlled trial. The purpose of the run-in arm was to trial the intervention content with participants and the purpose of any data collection in this arm was to refine the intervention content to enhance acceptability and feasibility for the RCT. Since run-in participants were not enrolled in the RCT we are not reporting these results.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>STRIDE</title>
          <description>Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment&#xD;
STRIDE: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.</description>
        </group>
        <group group_id="P2">
          <title>Medication Monitoring Control</title>
          <description>Medication monitoring plus standard care&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment&#xD;
Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>STRIDE</title>
          <description>Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment&#xD;
STRIDE: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.</description>
        </group>
        <group group_id="B2">
          <title>Medication Monitoring Control</title>
          <description>Medication monitoring plus standard care&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment&#xD;
Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.2" spread="10.6"/>
                    <measurement group_id="B2" value="54.9" spread="11.2"/>
                    <measurement group_id="B3" value="56.1" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American or Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Adjuvant Endocrine Therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Aromatase Inhibitor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tamoxifen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Breast Cancer Stage</title>
          <description>Breast Cancer Stage per the AJCC Cancer Staging Manual and as determined by the treating oncologist. As the stage of breast cancer increases from zero to three, the degree of severity increases, and the patient's prognosis worsens. Stage four breast cancer indicates that breast cancer has traveled outside of the breast and regional lymph nodes to a distant organ and is considered advanced breast cancer. Patients with stage four, advanced breast cancer were not eligible for this study.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Stage 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ovarian Suppression</title>
          <description>Ovarian suppression is the medical suppression of ovarian function often utilized in pre-menopausal patients with estrogen-receptor-positive breast cancer in combination with other anti-cancer therapies to lower estrogen levels. In this study, study staff determined if patients underwent ovarian suppression via chart review of the electronic medical record.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Receiving Ovarian Suppression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Receiving Ovarian Suppression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility and Acceptability</title>
        <description>The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate &gt; 50%), retention (follow-up assessment completion rate &gt; 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions [67%]).&#xD;
The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if &gt;75% of participants report average satisfaction scores greater than the CSQ's mid-point. The CSQ is scored on a four-point Likert scale with higher scores indicating higher satisfaction.</description>
        <time_frame>12 weeks</time_frame>
        <population>The analysis populations are as follows.&#xD;
Feasibility:&#xD;
Enrollment - 141 eligible participants were approached and 100 participants enrolled (70.9%).&#xD;
For the remainder of the feasibility analyses, the analysis population will utilize a denominator of 100 participants enrolled to the STRIDE study.&#xD;
For the acceptability analysis, the analysis population will utilize a denominator of the 43 participants who completed at least four out of the six STRIDE sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>STRIDE</title>
            <description>Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment&#xD;
STRIDE: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.</description>
          </group>
          <group group_id="O2">
            <title>Medication Monitoring Control</title>
            <description>Medication monitoring plus standard care&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment&#xD;
Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility and Acceptability</title>
          <description>The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate &gt; 50%), retention (follow-up assessment completion rate &gt; 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions [67%]).&#xD;
The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if &gt;75% of participants report average satisfaction scores greater than the CSQ's mid-point. The CSQ is scored on a four-point Likert scale with higher scores indicating higher satisfaction.</description>
          <population>The analysis populations are as follows.&#xD;
Feasibility:&#xD;
Enrollment - 141 eligible participants were approached and 100 participants enrolled (70.9%).&#xD;
For the remainder of the feasibility analyses, the analysis population will utilize a denominator of 100 participants enrolled to the STRIDE study.&#xD;
For the acceptability analysis, the analysis population will utilize a denominator of the 43 participants who completed at least four out of the six STRIDE sessions.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Feasibility - Retention at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feasibility - Session Attendance</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acceptability</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="NA">The Medication Monitoring Control Group did not attend intervention sessions and so did not rate acceptability.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period</title>
        <description>Medication Event Monitoring System (MEMS Caps): Participants will store medication in the MEMS bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the 24-week study period between groups.</description>
        <time_frame>Mean medication adherence rates over 24 weeks</time_frame>
        <population>Analysis Population includes the participants in both arms using the MEMs caps throughout the study period.</population>
        <group_list>
          <group group_id="O1">
            <title>STRIDE</title>
            <description>Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment&#xD;
STRIDE: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.</description>
          </group>
          <group group_id="O2">
            <title>Medication Monitoring Control</title>
            <description>Medication monitoring plus standard care&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment&#xD;
Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring</description>
          </group>
        </group_list>
        <measure>
          <title>Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period</title>
          <description>Medication Event Monitoring System (MEMS Caps): Participants will store medication in the MEMS bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the 24-week study period between groups.</description>
          <population>Analysis Population includes the participants in both arms using the MEMs caps throughout the study period.</population>
          <units>percentage of medication taken</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.75" lower_limit="78.80" upper_limit="90.70"/>
                    <measurement group_id="O2" value="82.00" lower_limit="75.98" upper_limit="88.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis comparing the change in monthly adherence to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.504</p_value>
            <p_value_desc>a priori threshold p&lt;0.05</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Adjusted for distress and receipt of ovarian suppression.</method_desc>
            <param_type>Slope</param_type>
            <param_value>-0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.59</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis comparing the change in weekly adherence rates to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.225</p_value>
            <p_value_desc>a priori threshold p&lt;0.05</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Adjusted for distress and receipt of ovarian suppression</method_desc>
            <param_type>Slope</param_type>
            <param_value>-0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.44</ci_lower_limit>
            <ci_upper_limit>-0.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline</title>
        <description>Medication Adherence Report Scale (MARS-5): Changes in self-reported adherence to adjuvant endocrine therapy between groups will be explored using the MARS-5 at 3-months post-baseline. The MARS-5 assesses adherence to treatment and has been used specifically in the context of AET adherence. The scale consists of five items that ask about suboptimal adherence behaviors, such as &quot;I stop taking my adjuvant endocrine therapy medicine for a while.&quot; Each item is answered on a scale of 1 (Always) to 5 (Never). Scores range from 5 to 25 points with scores less than 25 defined as low adherence to the medication.</description>
        <time_frame>Baseline, and post-intervention at 12-weeks post-baseline</time_frame>
        <population>Analysis Population includes the participants in both arms that completed the MARS-5 measure at 12 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>STRIDE</title>
            <description>Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment&#xD;
STRIDE: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.</description>
          </group>
          <group group_id="O2">
            <title>Medication Monitoring Control</title>
            <description>Medication monitoring plus standard care&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment&#xD;
Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline</title>
          <description>Medication Adherence Report Scale (MARS-5): Changes in self-reported adherence to adjuvant endocrine therapy between groups will be explored using the MARS-5 at 3-months post-baseline. The MARS-5 assesses adherence to treatment and has been used specifically in the context of AET adherence. The scale consists of five items that ask about suboptimal adherence behaviors, such as &quot;I stop taking my adjuvant endocrine therapy medicine for a while.&quot; Each item is answered on a scale of 1 (Always) to 5 (Never). Scores range from 5 to 25 points with scores less than 25 defined as low adherence to the medication.</description>
          <population>Analysis Population includes the participants in both arms that completed the MARS-5 measure at 12 weeks</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.99" lower_limit="23.61" upper_limit="24.36"/>
                    <measurement group_id="O2" value="23.86" lower_limit="23.49" upper_limit="24.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis comparing the change in self-reported endocrine therapy adherence between groups on the MARS-5 scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.630</p_value>
            <p_value_desc>a priori threshold p &lt; 0.05</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.40</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.</title>
        <description>Cancer Therapy Satisfaction Questionnaire (CTSQ): Changes in self-reported satisfaction with AET will be explored between groups at 12 weeks post-baseline with the Cancer Therapy Satisfaction Questionnaire (CTSQ). The CTSQ is a previously published 21-item measure that evaluates patients' beliefs about the following aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for non-adherence. We used the satisfaction with cancer therapy subscale. Each item is scored on a scale of 1 (&quot;Never&quot; or &quot;Very inconvenient&quot;) to 5 (&quot;Always&quot; or Very Convenient&quot;). A greater score on this measure indicates greater patient cancer therapy satisfaction. Scores can range from a minimum of 0 to a maximum of 100.</description>
        <time_frame>Baseline, and post-intervention at 12-weeks post-baseline</time_frame>
        <population>The analysis population includes the 92 participants in the STRIDE study who completed the CTSQ at 12 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>STRIDE</title>
            <description>Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment&#xD;
STRIDE: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.</description>
          </group>
          <group group_id="O2">
            <title>Medication Monitoring Control</title>
            <description>Medication monitoring plus standard care&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment&#xD;
Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.</title>
          <description>Cancer Therapy Satisfaction Questionnaire (CTSQ): Changes in self-reported satisfaction with AET will be explored between groups at 12 weeks post-baseline with the Cancer Therapy Satisfaction Questionnaire (CTSQ). The CTSQ is a previously published 21-item measure that evaluates patients' beliefs about the following aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for non-adherence. We used the satisfaction with cancer therapy subscale. Each item is scored on a scale of 1 (&quot;Never&quot; or &quot;Very inconvenient&quot;) to 5 (&quot;Always&quot; or Very Convenient&quot;). A greater score on this measure indicates greater patient cancer therapy satisfaction. Scores can range from a minimum of 0 to a maximum of 100.</description>
          <population>The analysis population includes the 92 participants in the STRIDE study who completed the CTSQ at 12 weeks.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.53" lower_limit="63.82" upper_limit="69.23"/>
                    <measurement group_id="O2" value="63.94" lower_limit="61.30" upper_limit="66.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis comparing the change in satisfaction with adjuvant endocrine therapy between groups on the CTSQ from baseline to 12 weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.186</p_value>
            <p_value_desc>a priori threshold p &lt; 0.05</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>6.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline</title>
        <description>Breast Cancer Prevention Trial Symptom Scale (BCPT): The investigators will examine changes in self-reported symptom distress on the BCPT between groups at 12 weeks post-baseline. The BCPT is a symptom checklist used to document physical and psychological symptoms associated with ET use. The measure includes several clinically-relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.</description>
        <time_frame>Baseline and post-intervention at 12 weeks post-baseline</time_frame>
        <population>The analysis population includes the 92 participants in the STRIDE study who completed the BCPT at 12 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>STRIDE</title>
            <description>Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment&#xD;
STRIDE: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.</description>
          </group>
          <group group_id="O2">
            <title>Medication Monitoring Control</title>
            <description>Medication monitoring plus standard care&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment&#xD;
Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline</title>
          <description>Breast Cancer Prevention Trial Symptom Scale (BCPT): The investigators will examine changes in self-reported symptom distress on the BCPT between groups at 12 weeks post-baseline. The BCPT is a symptom checklist used to document physical and psychological symptoms associated with ET use. The measure includes several clinically-relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.</description>
          <population>The analysis population includes the 92 participants in the STRIDE study who completed the BCPT at 12 weeks.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.89" lower_limit="17.98" upper_limit="21.79"/>
                    <measurement group_id="O2" value="20.67" lower_limit="18.82" upper_limit="22.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis comparing the change in symptom distress between groups on the BCPT scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.562</p_value>
            <p_value_desc>a priori threshold p &lt; 0.05</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.49</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>STRIDE</title>
          <description>Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)&#xD;
Two 15-minute check-in phone calls later in the study&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment&#xD;
STRIDE: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.</description>
        </group>
        <group group_id="E2">
          <title>Medication Monitoring Control</title>
          <description>Medication monitoring plus standard care&#xD;
Participants will store hormonal therapy medication in a bottle provided by the study team.&#xD;
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment&#xD;
Medication Monitoring Control: Care provided as standard by the hospital and medication monitoring</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study recruitment paused due to the COVID-19 pandemic from mid-March 2020 through May of 2020.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jamie Jacobs, PhD</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-643-1777</phone>
      <email>jjacobs@mgh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03837496
org study id: 18-603
secondary id: K07CA211107
nct id: NCT03837496
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the feasibility and acceptability of a brief,
      virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking
      hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal
      therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.
Background: The majority of breast cancer is hormone sensitive and treated with 10 years of
      adjuvant endocrine therapy (AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of
      recurrence and improve survival; however, adherence to AET among breast cancer survivors
      (BCS) is a challenge, with half of women becoming non-adherent within five years. Difficulty
      coping with symptoms (e.g., sleep problems, hot flashes, weight gain, fatigue) and
      psychosocial distress (i.e., depression or anxiety symptoms), and other emotional and
      logistical factors are major barriers to adherence. There is a dearth of efficacious
      interventions targeting the needs and adherence challenges of BCS prescribed AET.

      Objective: To address this gap, the proposed study, funded by the National Cancer Institute,
      employs a mixed-methods design to develop and test an evidence-based intervention (STRIDE) to
      enhance adherence to AET, improve symptom management, and reduce distress in breast cancer
      survivors.

      Specific Aims: The primary aims of this study are: 1) to examine the feasibility and
      acceptability of a tailored, small-group, virtual intervention (STRIDE) compared to a
      medication monitoring control for survivors of breast cancer taking AET, and 2) to explore
      the effects of the STRIDE intervention on adherence to AET, symptom distress, and
      satisfaction with AET.

      Study Design: Phase 1 included (1) semi-structured interviews with BCS on AET (n=30) and
      intervention development with psychologists and oncology clinicians. The intervention is a a
      brief, virtual, small-group, cognitive-behavioral intervention that aims to alleviate
      symptoms and side effects related to hormonal therapy or breast cancer, optimize
      medication-taking, and reduce emotional distress for breast cancer survivors taking hormonal
      therapy. Phase 2 will entail a run-in phase (n=5) to evaluate acceptability and further
      refine the intervention, followed by a randomized controlled pilot trial (n=100) to assess
      the feasibility of comparing the STRIDE intervention to a medication monitoring control with
      assessments and adherence monitoring over the course of six months. Participants will be
      recruited at Massachusetts General Hospital Cancer Center and three community satellite
      sites. Eligible participants will be hormone-receptor positive breast cancer survivors
      prescribed AET who are experiencing distress related to AET (e.g., adherence difficulties,
      side effects, etc.). This research study involves completing 3 questionnaire batteries at the
      time of enrollment, 12 weeks, and 24 weeks. The participant will also be asked to store their
      hormonal therapy pills in a medication bottle provided by the study team throughout the 24
      week study period. If the participants are randomized to receive the STRIDE intervention, the
      participant will have six weekly one-hour virtual (videoconferencing) sessions in small
      groups with a trained clinician followed by two 15-minute check-in phone calls later in the
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: The outcomes assessor will be blinded to the participant's study condition
measure: Feasibility and Acceptability
time frame: 12 weeks
description: The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate > 50%), retention (follow-up assessment completion rate > 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions [67%]).
The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if >75% of participants report average satisfaction scores greater than the CSQ's mid-point. The CSQ is scored on a four-point Likert scale with higher scores indicating higher satisfaction.
measure: Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period
time frame: Mean medication adherence rates over 24 weeks
description: Medication Event Monitoring System (MEMS Caps): Participants will store medication in the MEMS bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the 24-week study period between groups.
measure: Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline
time frame: Baseline, and post-intervention at 12-weeks post-baseline
description: Medication Adherence Report Scale (MARS-5): Changes in self-reported adherence to adjuvant endocrine therapy between groups will be explored using the MARS-5 at 3-months post-baseline. The MARS-5 assesses adherence to treatment and has been used specifically in the context of AET adherence. The scale consists of five items that ask about suboptimal adherence behaviors, such as "I stop taking my adjuvant endocrine therapy medicine for a while." Each item is answered on a scale of 1 (Always) to 5 (Never). Scores range from 5 to 25 points with scores less than 25 defined as low adherence to the medication.
measure: Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.
time frame: Baseline, and post-intervention at 12-weeks post-baseline
description: Cancer Therapy Satisfaction Questionnaire (CTSQ): Changes in self-reported satisfaction with AET will be explored between groups at 12 weeks post-baseline with the Cancer Therapy Satisfaction Questionnaire (CTSQ). The CTSQ is a previously published 21-item measure that evaluates patients' beliefs about the following aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for non-adherence. We used the satisfaction with cancer therapy subscale. Each item is scored on a scale of 1 ("Never" or "Very inconvenient") to 5 ("Always" or Very Convenient"). A greater score on this measure indicates greater patient cancer therapy satisfaction. Scores can range from a minimum of 0 to a maximum of 100.
measure: Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline
time frame: Baseline and post-intervention at 12 weeks post-baseline
description: Breast Cancer Prevention Trial Symptom Scale (BCPT): The investigators will examine changes in self-reported symptom distress on the BCPT between groups at 12 weeks post-baseline. The BCPT is a symptom checklist used to document physical and psychological symptoms associated with ET use. The measure includes several clinically-relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.
arm group label: STRIDE Run-In
arm group type: Experimental
description: Stride is delivered as a Five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician
Two 15-minute check-in phone calls later in the study
Participants will store hormonal therapy medication in a bottle provided by the study team.
Participants will complete questionnaires at enrollment and 3-months post- enrollment
arm group label: STRIDE
arm group type: Experimental
description: Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)
Two 15-minute check-in phone calls later in the study
Participants will store hormonal therapy medication in a bottle provided by the study team.
Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment
arm group label: Medication Monitoring Control
arm group type: Active Comparator
description: Medication monitoring plus standard care
Participants will store hormonal therapy medication in a bottle provided by the study team.
Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment
intervention type: Other
intervention name: STRIDE
description: STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.
arm group label: STRIDE
arm group label: STRIDE Run-In
intervention type: Other
intervention name: Medication Monitoring Control
description: Care provided as standard by the hospital and medication monitoring
arm group label: Medication Monitoring Control
criteria: 
gender: Female
minimum age: 21 Months
maximum age: N/A
healthy volunteers: No
last name: Jamie M. Jacobs, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jamie Jacobs
investigator title: Principal Investigator
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study recruitment paused due to the COVID-19 pandemic from mid-March 2020 through May of 2020.
point of contact: 