Clinical trial · Interventional
I HEAL for Breast Cancer Survivors With Diabetes
Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diabetes Coping Skills Training (DCST) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Diabetes Coping Skills training (DCST)
- description
- Twelve sessions are delivered over 6 months using a faded contact model involving 6 weekly sessions, 3 biweekly sessions and 3 monthly sessions.
- interventionNames
- Behavioral: Diabetes Coping Skills Training (DCST)
- type
- NO_INTERVENTION
- label
- Diabetes Education
- description
- one 60 minute diabetes education session.
Primary outcomes (3)
- measure
- Change in physical symptoms
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDShelby 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