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NCT07539649
LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training
Conditions: Survivorship
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: Medical University of South Carolina
Summary
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
Inclusion Criteria:
1. identify as female
2. be diagnosed with metastatic (AJCC stage IV) breast cancer
3. be receiving care for metastatic breast cancer at Hollings Cancer Center
4. endorse \>3 out of 10 on the NCCN distress thermometer over the past week plus at least one emotional concern on the problem checklist
5. be \> 18 years of age
6. be able to understand, speak, and read English
7. be able to provide informed consent.
Exclusion Criteria:
1. reported or suspected cognitive impairment
2. presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
3. expected survival \
Source: ClinicalTrials.gov (NCT07539649). StuddyBuddy aggregates publicly available trial information.
