Clinical trial NCT02970344: I HEAL for Breast Cancer Survivors With Diabetes
Official title: Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Coping Skills Training
Diabetes Education
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and data will be obtained from home blood glucose monitoring devices. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months.

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. 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.

Eligibility 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,
* 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.

Primary outcomes:
measure: Change in physical symptoms
timeFrame: baseline, 3 months, 6 months and 12 months
measure: Change in psychological distress
timeFrame: baseline, 3 months, 6 months and 12 months
measure: Change in psychological distress
timeFrame: baseline, 3 months, 6 months and 12 months
Secondary outcomes:
measure: Accessing change in Diabetes self-management behaviors via self reported medication adherence
timeFrame: Baseline to 12 months
measure: Accessing change in Diabetes self-management behavior via Barriers to taking medication
timeFrame: Baseline to 12 months
measure: Accessing change in Diabetes self-management behavior via Adherence to diabetes self-management behaviors
timeFrame: Baseline to 12 months
measure: Accessing change in Diabetes self-management behavior via Use of home blood glucose monitoring
timeFrame: Baseline, 6 months and 12 months
measure: Improved glycemic control
timeFrame: Baseline, 6 months and 12 months
measure: Change in self-efficacy
timeFrame: Baseline, 6 months and 12 months
measure: Change in Physical Activity
timeFrame: Baseline, 6 months and 12 months
measure: Assessing change in Physical Activity
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Rebecca A Shelby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shelby RA, Dorfman CS, Arthur SS, Bosworth HB, Corsino L, Sutton L, Owen L, Erkanli A, Keefe F, Corbett C, Kimmick G. Improving health engagement and lifestyle management for breast cancer survivors with diabetes. Contemp Clin Trials. 2020 May;92:105998. doi: 10.1016/j.cct.2020.105998. Epub 2020 Apr 11.