Clinical trial · Interventional
Creating Opportunities For Personal Empowerment (COPE) In Women With Breast Cancer During First-Line Therapy: A Pilot Randomized Controlled Trial
NCT07610499CI-TRIAL-00112798not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To learn if the Creating Opportunities for Personal Empowerment (COPE) intervention is feasible, acceptable, and helpful (compared to usual care) in women with breast cancer who are receiving first line treatment.
Conditions
Conditions (4)
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 |
| COPE | — | UNRESOLVED | — |
| First Line Therapy | — | UNRESOLVED | — |
| Randomized Controlled Trial (RCT) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention sessions | Other | — | UNRESOLVED |
| Standard of Care (SOC) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- COPE Intervention
- description
- There are seven sessions within the COPE intervention. Sessions will be facilitated by a research team member weekly over the course of seven weeks and each session will take approximately 45 minutes.
- interventionNames
- Other: Intervention sessions
- type
- OTHER
- label
- Control Group
- description
- Usual care will consist of standard care provided by the participant's healthcare team, including any recommendations regarding coping with stress, anxiety, depressive symptoms, resilience, and quality of life related to their breast cancer diagnosis and treatment.
- interventionNames
- Other: Standard of Care (SOC)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility Criteria * Female * Age 18 years and older * Diagnosed with stage I-III breast cancer * Receiving first line treatment for breast cancer * Receiving treatment at MD Anderson * Able to read, speak, and consent in English * Able to understand and be willing to sign a written informed consent document * Able to complete the study questionnaires and intervention sessions Exclusion Criteria * Diagnosed with multiple tumor types * Diagnosed with stage IV breast cancer * Unable to provide consent, such as cognitively impaired individuals * Has a preexisting psychiatric diagnosis (e.g., bipolar depression)
References
Publications (0)
Data not yet available
No reference posted for this study.