Clinical trial · Interventional
Integrated Intervention for Breast Cancer Survivors With Diabetes
Disease Beliefs and Cognition: Effect on Diabetes Management in Older Breast Cancer Survivors
- 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 purpose of this research study is to learn how therapy for breast cancer or DCIS/LCIS affects cognitive function and beliefs about cancer/DCIS/LCIS and diabetes (DM). For this portion of the study, the study team will integrate the information collected at previous follow-ups to create educational modules to change disease and medication beliefs and improve DM self-management behaviors (SMB). The educational counseling modules the study team plans to pilot test are rooted in the Common Sense Self-Regulation Model, a theory that posits that health behaviors are influenced by two parallel processes: cognitive (i.e., disease beliefs and expectations) and affective (i.e., emotional responses).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention Control | Behavioral | — | UNRESOLVED |
| Integrated Intervention for Breast Cancer Survivors with Diabetes | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Integrated Intervention
- description
- 4 intervention sessions over 6 months using an educational and counseling intervention developed by the study team.
- interventionNames
- Behavioral: Integrated Intervention for Breast Cancer Survivors with Diabetes
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Attention Control group - Supportive counseling for DM management
- interventionNames
- Behavioral: Attention Control
Primary outcomes (1)
- measure
- Illness Perceptions Questionnaire (IPQ scores)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * An enrolled participant in the main observational study * Completed 18-month follow-up interview * Have at least 1 SMB target (Scored less than scored \<4.5 on the MARS for DM, and/or \<80% on objective adherence at 12-month (DM), and/or scored \<7 on SDSCA) * Must be willing to participate in the pilot intervention Exclusion Criteria: \- Participant with suspected clinical depression on CESD (scored ≥20)
References
Publications (0)
Data not yet available