<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/NCT03752268</url>
  </required_header>
  <id_info>
    <org_study_id>13-614</org_study_id>
    <secondary_id>ACS MRSG 14-107-01</secondary_id>
    <nct_id>NCT03752268</nct_id>
  </id_info>
  <brief_title>Development of an Intervention to Enhance Cancer Pain Management</brief_title>
  <official_title>Development of an Intervention to Enhance Cancer Pain Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</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>
      This research study is being done to understand how patients with chronic cancer pain take&#xD;
      their long-acting opioid medications, and to develop an intervention to enhance cancer pain&#xD;
      management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Long-acting opioids are a common treatment for cancer pain. The purpose of this study is to&#xD;
      develop a program for patients who are taking a prescribed long-acting opioid for their&#xD;
      cancer pain. Participants will be enrolled in this study at the Massachusetts General&#xD;
      Hospital Cancer Center. This 14-week study involves completing a set of questionnaires at&#xD;
      three different times during the study period. . During the study period, participants will&#xD;
      use electronic pill caps to monitor their pain medication taking. They also will attend a&#xD;
      series of three visits with one of the nurse practitioners on their care cancer team. The&#xD;
      visits will focus on learning and practicing skills for managing cancer pain. The information&#xD;
      that the investigators collect will help identify whether the sessions are feasible and&#xD;
      useful to patients during the course of treatment for cancer pain.&#xD;
&#xD;
      This trial will consist of two parts:&#xD;
&#xD;
      Part 1: This is a single-group prospective observational study. Investigators will use&#xD;
      quantitative and qualitative methods to examine rates, predictors and outcomes of adherence&#xD;
      to LA opioids over a period of approximately eight weeks. This information will be used to&#xD;
      inform Part 2 intervention development and testing.&#xD;
&#xD;
      Part 2: Investigators will test the behavioral intervention in a non-randomized open pilot,&#xD;
      over a period of approximately six weeks. Intervention process data, psychosocial and medical&#xD;
      data, and post-intervention feedback will be collected to assess feasibility and&#xD;
      acceptability. In an iterative process, ongoing data from exit interviews and therapist&#xD;
      experience will be used to modify the intervention protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 15, 2014</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who complete study sessions</measure>
    <time_frame>2 Years</time_frame>
    <description>Proportion of enrolled participants who complete the study, based on a criterion of greater than or equal to 75% completed sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who identify study components as acceptable</measure>
    <time_frame>2 years</time_frame>
    <description>Individual response frequencies of 4 Likert-type scale items, designed for this study, that rate acceptability of 1) number of study sessions, 2) length of study sessions, 3) usefulness of study material, and 4) impact of study material on pain management, and themes of two free-text items that elicit unstructured participant feedback about acceptability of these study components.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Other Cancer</condition>
  <arm_group>
    <arm_group_label>Enhancing Cancer Pain Management Part 1</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Will collect information from participants via self-report assessment at two time points: at baseline (i.e. study enrollment) and approximately 8 weeks post-baseline&#xD;
Will then use MEMS to monitor LA opioid intake over approximately 8 weeks&#xD;
A subset of enrolled participants (n=20) will be invited to participate in an optional one-time qualitative exit interview with a study staff member trained in conducting qualitative interviews</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhancing Cancer Pain Management Part 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enhancing Cancer Pain Management will consist of 3 individual manualized sessions&#xD;
The 3 individual manualized sessions will be conducted (approximately 20 minutes each), led by a nurse practitioner, to provide sufficient dose for change in adherence behaviors.&#xD;
Learning and practicing skills for managing cancer-related pain and adhering to prescribed LA opioid regimens.&#xD;
Study staff will provide participants with MEMS caps and bottles at time of enrollment, to monitor LA opioid intake over approximately 14 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhancing Cancer Pain Management</intervention_name>
    <description>Patients will learn and practice an enduring framework of cognitive-behavioral strategies, to enhance adherence behavior, reduce intentional and unintentional deviations from the prescribed regimen.</description>
    <arm_group_label>Enhancing Cancer Pain Management Part 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 or older&#xD;
&#xD;
          -  Currently prescribed a long-acting (LA) opioid for nociceptive cancer pain (extended&#xD;
             release oxycodone, extended-release morphine, transdermal fentanyl patches, methadone&#xD;
             tablets)&#xD;
&#xD;
          -  Ability to comprehend study materials in English&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2&#xD;
&#xD;
          -  In charge of administering own pain medications&#xD;
&#xD;
          -  Part 2 study only: within 4 months of current prescription of LA opioid for&#xD;
             nociceptive cancer pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impaired cognition, active substance disorder, or other active, unstable mental health&#xD;
             disorder&#xD;
&#xD;
          -  Current long-acting opioid treatment for pre-existing condition&#xD;
&#xD;
          -  Part 2 study only: Prior enrollment in the Part 1 study**&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lara Traeger, 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>02214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>May 20, 2021</last_update_submitted>
  <last_update_submitted_qc>May 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Lara Traeger</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Other Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cancer Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03752268
org study id: 13-614
secondary id: ACS MRSG 14-107-01
nct id: NCT03752268
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study is being done to understand how patients with chronic cancer pain take
      their long-acting opioid medications, and to develop an intervention to enhance cancer pain
      management.
Long-acting opioids are a common treatment for cancer pain. The purpose of this study is to
      develop a program for patients who are taking a prescribed long-acting opioid for their
      cancer pain. Participants will be enrolled in this study at the Massachusetts General
      Hospital Cancer Center. This 14-week study involves completing a set of questionnaires at
      three different times during the study period. . During the study period, participants will
      use electronic pill caps to monitor their pain medication taking. They also will attend a
      series of three visits with one of the nurse practitioners on their care cancer team. The
      visits will focus on learning and practicing skills for managing cancer pain. The information
      that the investigators collect will help identify whether the sessions are feasible and
      useful to patients during the course of treatment for cancer pain.

      This trial will consist of two parts:

      Part 1: This is a single-group prospective observational study. Investigators will use
      quantitative and qualitative methods to examine rates, predictors and outcomes of adherence
      to LA opioids over a period of approximately eight weeks. This information will be used to
      inform Part 2 intervention development and testing.

      Part 2: Investigators will test the behavioral intervention in a non-randomized open pilot,
      over a period of approximately six weeks. Intervention process data, psychosocial and medical
      data, and post-intervention feedback will be collected to assess feasibility and
      acceptability. In an iterative process, ongoing data from exit interviews and therapist
      experience will be used to modify the intervention protocol.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants who complete study sessions
time frame: 2 Years
description: Proportion of enrolled participants who complete the study, based on a criterion of greater than or equal to 75% completed sessions.
measure: Number of participants who identify study components as acceptable
time frame: 2 years
description: Individual response frequencies of 4 Likert-type scale items, designed for this study, that rate acceptability of 1) number of study sessions, 2) length of study sessions, 3) usefulness of study material, and 4) impact of study material on pain management, and themes of two free-text items that elicit unstructured participant feedback about acceptability of these study components.
arm group label: Enhancing Cancer Pain Management Part 1
arm group type: No Intervention
description: Will collect information from participants via self-report assessment at two time points: at baseline (i.e. study enrollment) and approximately 8 weeks post-baseline
Will then use MEMS to monitor LA opioid intake over approximately 8 weeks
A subset of enrolled participants (n=20) will be invited to participate in an optional one-time qualitative exit interview with a study staff member trained in conducting qualitative interviews
arm group label: Enhancing Cancer Pain Management Part 2
arm group type: Experimental
description: Enhancing Cancer Pain Management will consist of 3 individual manualized sessions
The 3 individual manualized sessions will be conducted (approximately 20 minutes each), led by a nurse practitioner, to provide sufficient dose for change in adherence behaviors.
Learning and practicing skills for managing cancer-related pain and adhering to prescribed LA opioid regimens.
Study staff will provide participants with MEMS caps and bottles at time of enrollment, to monitor LA opioid intake over approximately 14 weeks.
intervention type: Behavioral
intervention name: Enhancing Cancer Pain Management
description: Patients will learn and practice an enduring framework of cognitive-behavioral strategies, to enhance adherence behavior, reduce intentional and unintentional deviations from the prescribed regimen.
arm group label: Enhancing Cancer Pain Management Part 2
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Lara Traeger, 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: Lara Traeger
investigator title: Principal Investigator
mesh term: Cancer Pain
sharing ipd: No