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Not yet recruiting Not applicable NCT07539649

LiveWell mBC Pilot RCT

No applicable phase (e.g. observational)
Conditions: Survivorship

Sponsor: Medical University of South Carolina

trial.available_in: БГ
Overview
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).
Description
Participants will be randomized 2:1 to receive LiveWell mBC, an adapted DBT Skills Training intervention delivered to small groups of women with mBC via telehealth, or usual care. LiveWell mBC involves orientation + an 8-session skills training protocol of mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness. Participants will complete self-report measures at baseline, mid-intervention (Week 5), post-intervention (Week 11) and 1 month post-intervention (Week 15). It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (\>70% overall retention rate, \>70% LiveWell mBC completion rate); 2) RCT methods will demonstrated evidence of acceptability (\>50% enrollment rate, \>80% participant satisfaction); and 3) LiveWell participants will demonstrate reductions in distress (primary outcome) compared to Usual Care at 11-week follow-up.
Who can participate
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 \<6 months, as indicated by a hospice referral
Interventions
LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
BEHAVIORAL
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
31.01.2027
Registry ID
NCT07539649
Source
clinicaltrials.gov
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