I HEAL for Breast Cancer Survivors With Diabetes

NCT02970344 | Completed

• 1 other identifier: Pro00073234
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Coping Skills Training; Diabetes Education

Outcome Measures

Primary Outcomes (3)

• Change in physical symptoms

  The Checklist measures the severity of different symptoms (e.g., pain, fatigue, numbness and tingling) associated with illness and disease.

  baseline, 3 months, 6 months and 12 months

• Change in psychological distress

  The eight-item Patient Reported Outcomes Information System (PROMIS).

  baseline, 3 months, 6 months and 12 months

• Change in psychological distress

  Anxiety will be assessed using the seven-item GAD-7 Scale.

  baseline, 3 months, 6 months and 12 months

Secondary Outcomes (8)

• Accessing change in Diabetes self-management behaviors via self reported medication adherence

  Baseline to 12 months

• Accessing change in Diabetes self-management behavior via Barriers to taking medication

  Baseline to 12 months

• Accessing change in Diabetes self-management behavior via Adherence to diabetes self-management behaviors

  Baseline to 12 months

• Accessing change in Diabetes self-management behavior via Use of home blood glucose monitoring

  Baseline, 6 months and 12 months

• Improved glycemic control

  Baseline, 6 months and 12 months

Study Arms (2)

Diabetes Coping Skills training (DCST)

EXPERIMENTAL

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 Education

NO INTERVENTION

one 60 minute diabetes education session.

Interventions

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)

Diabetes Coping Skills training (DCST)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 32289471 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rebecca A Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: November 22, 2016
• Study Start: April 20, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-02

Locations

US (1)