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I HEAL for Breast Cancer Survivors With Diabetes (I HEAL)

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ClinicalTrials.gov Identifier: NCT02970344
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
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 (Fitbit) and data will be obtained from home blood glucose monitoring devices. Fasting insulin, fasting glucose, and glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Diabetes Coping Skills Training (DCST) Not Applicable

Detailed Description:
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. Fasting insulin, fasting glucose, and 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diabetes Coping Skills training (DCST)
Twelve sessions are delivered over 6 months using a faded contact model involving 6 weekly sessions, 3 biweekly sessions and 3 monthly sessions.
Behavioral: Diabetes Coping Skills Training (DCST)
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)
No Intervention: Diabetes Education
one 60 minute diabetes education session.



Primary Outcome Measures :
  1. Change in physical symptoms [ Time Frame: baseline, 3 months, 6 months and 12 months ]
    The Checklist measures the severity of different symptoms (e.g., pain, fatigue, numbness and tingling) associated with illness and disease.

  2. Change in psychological distress [ Time Frame: baseline, 3 months, 6 months and 12 months ]
    The eight-item Patient Reported Outcomes Information System (PROMIS).

  3. Change in psychological distress [ Time Frame: baseline, 3 months, 6 months and 12 months ]
    Anxiety will be assessed using the seven-item GAD-7 Scale.


Secondary Outcome Measures :
  1. Accessing change in Diabetes self-management behaviors via self reported medication adherence [ Time Frame: Baseline to 12 months ]
    Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.

  2. Accessing change in Diabetes self-management behavior via Barriers to taking medication [ Time Frame: Baseline to 12 months ]
    Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.

  3. Accessing change in Diabetes self-management behavior via Adherence to diabetes self-management behaviors [ Time Frame: Baseline to 12 months ]
    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.

  4. Accessing change in Diabetes self-management behavior via Use of home blood glucose monitoring [ Time Frame: Baseline, 6 months and 12 months ]
    Participants who receive DCST will exhibit greater improvements in adherence to blood glucose monitoring compare to the education group.

  5. Improved glycemic control [ Time Frame: Baseline, 6 months and 12 months ]
    Participants who receive DCST will show greater improvements in fasting insulin, fasting glucose, and HbA1c compared to the diabetes education alone.

  6. Change in self-efficacy [ Time Frame: Baseline, 6 months and 12 months ]
    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.

  7. Change in Physical Activity [ Time Frame: Baseline, 6 months and 12 months ]

    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.


  8. Assessing change in Physical Activity [ Time Frame: Baseline, 6 months and 12 months ]

    Wireless activity tracking devices (Fitbit) 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.

    Participants who receive DCST will show improved self efficacy for managing symptoms and diabetPhysical Activity




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of Stage I to III breast cancer,
  • diagnosis of diabetes mellitus type 2
  • completed local definitive treatment (i.e., surgical treatment, chemotherapy and/or radiation therapy),
  • physician verification of ability to participate in the intervention,
  • English speaking.

Exclusion Criteria:

  • <21 years of age,
  • cognitive or hearing impairment,
  • unable to provide meaningful consent (i.e., impairment such that descriptions of the research are not clearly understood),
  • presence of a health problem that precludes safe participation in the intervention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970344


Contacts
Contact: Rebecca A Shelby, PhD 919-416-3410 rebecca.shelby@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Rebecca A Shelby, PhD    919-416-3410    rebecca.shelby@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Rebecca A Shelby, PhD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02970344     History of Changes
Other Study ID Numbers: Pro00073234
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Coping Skills Training
Diabetes Education

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases