About this trial
In this pilot randomized controlled trial, women with metastatic breast cancer and at least mild distress (N=48) will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol, or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes).
Eligibility criteria
Qualifiers
identify as female
be diagnosed with metastatic (AJCC stage IV) breast cancer
be receiving care for metastatic breast cancer at Hollings Cancer Center
endorse >3 out of 10 on the NCCN distress thermometer over the past week plus at least one emotional concern on the problem checklist
Disqualifiers
reported or suspected cognitive impairment
presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
expected survival <6 months, as indicated by a hospice referral
Trial design
Treatments tested in this trial
- LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
Treatment groups
Locations
Sponsors and collaborators
Medical University of South Carolina
Lead sponsor
American Cancer Society, Inc.
Collaborator