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Completed

NCT Number: NCT02970344

I HEAL for Breast Cancer Survivors With Diabetes

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,
  • severe 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.

Treatment and study plan

Diabetes Coping Skills Training (DCST)

Behavioral

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)

Primary outcomes

  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 outcomes

  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 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 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes

Acronym: I HEAL

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2016
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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