Clinical trial · Interventional
Optimizing Quality of Life in Women Living With Metastatic Breast Cancer
Optimizing Quality of Life in Women Living With Metastatic Breast Cancer: Feasibility and Preliminary Efficacy of a Tailored, eHealth Supportive Oncology Intervention
- 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 study is to develop and tailor an intervention program to improve the quality of life in women living with metastatic breast cancer. In the first phase of this study, we conducted patient focus groups to gather information about the unique challenges of living with MBC and what kinds of support women would like to receive in a tailored Acceptance and Commitment Therapy (ACT) intervention. In the second phase of the study, we will conduct a three-arm randomized controlled trial to the tailored ACT intervention with both a Cognitive Behavioral Stress Management (CBSM) intervention and usual care. The CBSM and ACT intervention groups will meet with a trained facilitator and 8-9 other patients, once per week via videoconference for 90 minute sessions over the course of 8 weeks.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Behavioral | — | UNRESOLVED |
| Cognitive Behavioral Stress Management (CBSM) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Acceptance and Commitment Therapy (ACT)
- description
- Weekly video conference groups led by a trained facilitator introducing key concepts of ACT
- interventionNames
- Behavioral: Acceptance and Commitment Therapy (ACT)
- type
- ACTIVE_COMPARATOR
- label
- Cognitive Behavioral Stress Management (CBSM)
- description
- Weekly video conference groups led by a trained facilitator introducing key concepts of CBSM
- interventionNames
- Behavioral: Cognitive Behavioral Stress Management (CBSM)
- type
- NO_INTERVENTION
- label
- Usual care
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be diagnosed with metastatic (stage IV \[M1\]) female breast cancer, via physician diagnosis and confirmed through staff review of electronic medical record (i.e. imaging, surgical pathology reports, etc.). * Patients must be comfortable speaking English for participation in group sessions. * Patients must be age ≥ 18 years. * Patients taking part in the 8 week online pilot trial must have a physician-anticipated life expectancy of \> 6 months. * Patients must have the ability to understand, and the willingness to sign, a written informed consent prior to registration on study. Exclusion Criteria: * Patients who have severe or impairing psychiatric illness/social situations that would limit compliance with study requirements are not eligible to enroll. * Patients with early stage/non metastatic breast cancer (Stages I-III) are not eligible to enroll.
References
Publications (0)
Data not yet available