Optimizing Quality of Life in Women Living With Metastatic Breast Cancer: Feasibility and Preliminary Efficacy of a Tailored, eHealth Supportive Oncology Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Change in wellbeing and disease symptom bother
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in wellbeing and disease symptom bother
Time Frame: Approx. 3 months
Using the previously validated Functional Assessment of Cancer-Therapy-Breast (FACT-B), change in wellbeing and symptom bother will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.
Change in health-related quality of life (HRQoL)
Time Frame: Approx. 3 months
Using the previously validated NIH PROMIS profile, change in HRQoL will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.
Secondary Outcomes
- Change in meaning and purpose in life and positive affect(Approx. 3 months)
- Change in social support(Approx. 3 months)
Investigators
Patricia Moreno
Assistant Professor
Northwestern University