Optimizing Quality of Life in Women Living With Metastatic Breast Cancer
Completed · Not applicable
Conditions studied: Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04374825
- Run by
- Northwestern University
- People needed
- 31
- Starts
- 2019-04-24
- Expected to finish
- 2021-03-08
- Last updated by the study team
- 2021-09-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.