<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/NCT02970344</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00073234</org_study_id>
    <nct_id>NCT02970344</nct_id>
  </id_info>
  <brief_title>I HEAL for Breast Cancer Survivors With Diabetes</brief_title>
  <acronym>I HEAL</acronym>
  <official_title>Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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 proposed randomized clinical trial evaluates a diabetes coping skills training (DCST)&#xD;
      intervention for improving breast cancer survivors' abilities to manage symptoms and adhere&#xD;
      to recommended diabetes self-management. The telephone-based DCST protocol integrates three&#xD;
      key strategies to reduce symptoms and improve diabetes self-management: coping skills&#xD;
      training for managing symptoms, adherence skills training, and healthy lifestyle skills&#xD;
      training. The investigator will test the effects of the DCST intervention by comparing it to&#xD;
      diabetes education alone. Physical symptoms, psychological distress, diabetes self-management&#xD;
      behaviors, and self-efficacy for managing symptoms and diabetes self-management will be&#xD;
      assessed at baseline and 3, 6, and 12 months. Physical activity (i.e., daily steps and&#xD;
      distance) will be assessed using wireless activity trackers and data will be obtained from&#xD;
      home blood glucose monitoring devices. Glycosylated hemoglobin (HbA1c) will be assessed at&#xD;
      baseline, 6, and 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Together, breast cancer and type 2 diabetes represent a public health crisis. Approximately&#xD;
      20% of the 3.1 million breast cancer survivors in the U.S. have type 2 diabetes, and this&#xD;
      number is expected to grow. Breast cancer survivors who have type 2 diabetes are at high risk&#xD;
      for cancer recurrence, serious health complications, and premature death. Breast cancer&#xD;
      survivors with type 2 diabetes experience more severe, disabling symptoms and psychological&#xD;
      distress relative to breast cancer survivors without diabetes. For breast cancer survivors&#xD;
      with type 2 diabetes, maintaining glycemic control is critical for decreasing symptoms and&#xD;
      preventing serious health problems. Important diabetes self-management strategies include&#xD;
      physical activity, dietary modifications, medication, and blood glucose monitoring. Many&#xD;
      breast cancer survivors with type 2 diabetes have difficulty maintaining these behaviors and&#xD;
      achieving glycemic control. Physical symptoms and psychological distress are often barriers&#xD;
      to engaging in diabetes self-management. The proposed study evaluates a novel diabetes coping&#xD;
      skills training (DCST) intervention for improving breast cancer survivors' abilities to&#xD;
      manage symptoms and adhere to recommended diabetes self-management. The telephone-based DCST&#xD;
      protocol is based on our prior work and integrates three key theory-based strategies: coping&#xD;
      skills training for managing symptoms, adherence skills training, and healthy lifestyle&#xD;
      skills training. The proposed randomized clinical trial (N=230) will test the effects of the&#xD;
      DCST intervention by comparing it to diabetes education alone. Physical symptoms,&#xD;
      psychological distress, diabetes self-management behaviors, and self-efficacy will be&#xD;
      assessed at baseline and 3, 6, and 12 months. Physical activity will be assessed using&#xD;
      wireless activity trackers and data will be obtained from home blood glucose monitoring&#xD;
      devices. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. The&#xD;
      proposed study addresses a critical gap in the care of breast cancer survivors by evaluating&#xD;
      a novel behavioral intervention that aims to improve the management of symptoms, adherence,&#xD;
      and glycemic control in breast cancer survivors with type 2 diabetes. The findings of this&#xD;
      study could lead to significant improvements in clinical care and beneficial outcomes for&#xD;
      breast cancer survivors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in physical symptoms</measure>
    <time_frame>baseline, 3 months, 6 months and 12 months</time_frame>
    <description>The Checklist measures the severity of different symptoms (e.g., pain, fatigue, numbness and tingling) associated with illness and disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in psychological distress</measure>
    <time_frame>baseline, 3 months, 6 months and 12 months</time_frame>
    <description>The eight-item Patient Reported Outcomes Information System (PROMIS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in psychological distress</measure>
    <time_frame>baseline, 3 months, 6 months and 12 months</time_frame>
    <description>Anxiety will be assessed using the seven-item GAD-7 Scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accessing change in Diabetes self-management behaviors via self reported medication adherence</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accessing change in Diabetes self-management behavior via Barriers to taking medication</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accessing change in Diabetes self-management behavior via Adherence to diabetes self-management behaviors</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Participants who receive DCST will exhibit greater improvements in physical activity, dietary patterns, medication adherence, and adherence to blood glucose monitoring compare to the education group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accessing change in Diabetes self-management behavior via Use of home blood glucose monitoring</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>Participants who receive DCST will exhibit greater improvements in adherence to blood glucose monitoring compare to the education group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved glycemic control</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>Participants who receive DCST will show greater improvements in HbA1c compared to the diabetes education alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>This contains 5 items that inquire about patients' certainty about degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>Patient-reported physical activity will be assessed using the well-validated Community Healthy Activities Model Program for Seniors (CHAMPS).&#xD;
Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing change in Physical Activity</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>Wireless activity tracking devices will be used to assess daily steps and distance.&#xD;
Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Diabetes Coping Skills training (DCST)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twelve sessions are delivered over 6 months using a faded contact model involving 6 weekly sessions, 3 biweekly sessions and 3 monthly sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetes Education</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>one 60 minute diabetes education session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diabetes Coping Skills Training (DCST)</intervention_name>
    <description>Diabetes Coping Skills Training (DCST) consist of twelve 50 minutes sessions delivered over 6 months using a faded contact model ( 6 weekly session, 3 biweekly sessions and 3 monthly sessions)</description>
    <arm_group_label>Diabetes Coping Skills training (DCST)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of Stage I to III breast cancer,&#xD;
&#xD;
          -  diagnosis of diabetes mellitus type 2&#xD;
&#xD;
          -  completed local definitive treatment (i.e., surgical treatment, chemotherapy and/or&#xD;
             radiation therapy),&#xD;
&#xD;
          -  physician verification of ability to participate in the intervention,&#xD;
&#xD;
          -  English speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;21 years of age,&#xD;
&#xD;
          -  severe cognitive or hearing impairment,&#xD;
&#xD;
          -  unable to provide meaningful consent (i.e., impairment such that descriptions of the&#xD;
             research are not clearly understood),&#xD;
&#xD;
          -  presence of a health problem that precludes safe participation in the intervention.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca A Shelby, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>October 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coping Skills Training</keyword>
  <keyword>Diabetes Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- 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/NCT02970344
org study id: Pro00073234
nct id: NCT02970344
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed randomized clinical trial evaluates a diabetes coping skills training (DCST)
      intervention for improving breast cancer survivors' abilities to manage symptoms and adhere
      to recommended diabetes self-management. The telephone-based DCST protocol integrates three
      key strategies to reduce symptoms and improve diabetes self-management: coping skills
      training for managing symptoms, adherence skills training, and healthy lifestyle skills
      training. The investigator will test the effects of the DCST intervention by comparing it to
      diabetes education alone. Physical symptoms, psychological distress, diabetes self-management
      behaviors, and self-efficacy for managing symptoms and diabetes self-management will be
      assessed at baseline and 3, 6, and 12 months. Physical activity (i.e., daily steps and
      distance) will be assessed using wireless activity trackers and data will be obtained from
      home blood glucose monitoring devices. Glycosylated hemoglobin (HbA1c) will be assessed at
      baseline, 6, and 12 months.
Together, breast cancer and type 2 diabetes represent a public health crisis. Approximately
      20% of the 3.1 million breast cancer survivors in the U.S. have type 2 diabetes, and this
      number is expected to grow. Breast cancer survivors who have type 2 diabetes are at high risk
      for cancer recurrence, serious health complications, and premature death. Breast cancer
      survivors with type 2 diabetes experience more severe, disabling symptoms and psychological
      distress relative to breast cancer survivors without diabetes. For breast cancer survivors
      with type 2 diabetes, maintaining glycemic control is critical for decreasing symptoms and
      preventing serious health problems. Important diabetes self-management strategies include
      physical activity, dietary modifications, medication, and blood glucose monitoring. Many
      breast cancer survivors with type 2 diabetes have difficulty maintaining these behaviors and
      achieving glycemic control. Physical symptoms and psychological distress are often barriers
      to engaging in diabetes self-management. The proposed study evaluates a novel diabetes coping
      skills training (DCST) intervention for improving breast cancer survivors' abilities to
      manage symptoms and adhere to recommended diabetes self-management. The telephone-based DCST
      protocol is based on our prior work and integrates three key theory-based strategies: coping
      skills training for managing symptoms, adherence skills training, and healthy lifestyle
      skills training. The proposed randomized clinical trial (N=230) will test the effects of the
      DCST intervention by comparing it to diabetes education alone. Physical symptoms,
      psychological distress, diabetes self-management behaviors, and self-efficacy will be
      assessed at baseline and 3, 6, and 12 months. Physical activity will be assessed using
      wireless activity trackers and data will be obtained from home blood glucose monitoring
      devices. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. The
      proposed study addresses a critical gap in the care of breast cancer survivors by evaluating
      a novel behavioral intervention that aims to improve the management of symptoms, adherence,
      and glycemic control in breast cancer survivors with type 2 diabetes. The findings of this
      study could lead to significant improvements in clinical care and beneficial outcomes for
      breast cancer survivors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in physical symptoms
time frame: baseline, 3 months, 6 months and 12 months
description: The Checklist measures the severity of different symptoms (e.g., pain, fatigue, numbness and tingling) associated with illness and disease.
measure: Change in psychological distress
time frame: baseline, 3 months, 6 months and 12 months
description: The eight-item Patient Reported Outcomes Information System (PROMIS).
measure: Change in psychological distress
time frame: baseline, 3 months, 6 months and 12 months
description: Anxiety will be assessed using the seven-item GAD-7 Scale.
measure: Accessing change in Diabetes self-management behaviors via self reported medication adherence
time frame: Baseline to 12 months
description: Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.
measure: Accessing change in Diabetes self-management behavior via Barriers to taking medication
time frame: Baseline to 12 months
description: Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.
measure: Accessing change in Diabetes self-management behavior via Adherence to diabetes self-management behaviors
time frame: Baseline to 12 months
description: Participants who receive DCST will exhibit greater improvements in physical activity, dietary patterns, medication adherence, and adherence to blood glucose monitoring compare to the education group.
measure: Accessing change in Diabetes self-management behavior via Use of home blood glucose monitoring
time frame: Baseline, 6 months and 12 months
description: Participants who receive DCST will exhibit greater improvements in adherence to blood glucose monitoring compare to the education group.
measure: Improved glycemic control
time frame: Baseline, 6 months and 12 months
description: Participants who receive DCST will show greater improvements in HbA1c compared to the diabetes education alone.
measure: Change in self-efficacy
time frame: Baseline, 6 months and 12 months
description: This contains 5 items that inquire about patients' certainty about degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication.
measure: Change in Physical Activity
time frame: Baseline, 6 months and 12 months
description: Patient-reported physical activity will be assessed using the well-validated Community Healthy Activities Model Program for Seniors (CHAMPS).
Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.
measure: Assessing change in Physical Activity
time frame: Baseline, 6 months and 12 months
description: Wireless activity tracking devices will be used to assess daily steps and distance.
Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.
arm group label: Diabetes Coping Skills training (DCST)
arm group type: Experimental
description: Twelve sessions are delivered over 6 months using a faded contact model involving 6 weekly sessions, 3 biweekly sessions and 3 monthly sessions.
arm group label: Diabetes Education
arm group type: No Intervention
description: one 60 minute diabetes education session.
intervention type: Behavioral
intervention name: Diabetes Coping Skills Training (DCST)
description: Diabetes Coping Skills Training (DCST) consist of twelve 50 minutes sessions delivered over 6 months using a faded contact model ( 6 weekly session, 3 biweekly sessions and 3 monthly sessions)
arm group label: Diabetes Coping Skills training (DCST)
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca A Shelby, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus