Study Summary
This trial is testing whether a type of psychotherapy called Acceptance and Commitment Therapy (ACT) can help reduce fatigue, interference with activities, mood, and cognition in people with metastatic breast cancer (MBC). ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, work), and engaging in activities consistent with these values. A total of 250 patients will be randomly assigned to either the ACT intervention or an education/support condition. Patients in both conditions will participate in six weekly 50-minute telephone sessions. Outcomes will be assessed at baseline, 2 weeks post
- Metastatic Breast Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 6 Secondary · Reporting Duration: 2 weeks, 3 months, and 6 months post-intervention
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Education/Support
1 of 2
Acceptance and Commitment Therapy
1 of 2
Active Control
Experimental Treatment
250 Total Participants · 2 Treatment Groups
Primary Treatment: Acceptance and Commitment Therapy · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are there still opportunities to join this experimental research?
"Affirmative. Data available on clinicaltrials.gov reveals that this scientific experiment, initially posted in June of 2019, is actively seeking participants. Approximately 250 individuals must be recruited from a single research facility." - Anonymous Online Contributor
What is the current enrollment size of this experiment?
"Affirmative, the contents on clinicaltrials.gov demonstrate that this medical experiment is actively recruiting volunteers. It was initially announced on June 20th 2019 and has been edited as of December 29 2021. The study requires 250 participants from one location." - Anonymous Online Contributor
Has the FDA confirmed the efficacy of Acceptance and Commitment Therapy?
"This treatment is backed by preliminary safety evidence, resulting in an estimated score of 2. Unfortunately, there are no available studies which have looked at the efficacy of Acceptance and Commitment Therapy at this time." - Anonymous Online Contributor