Clinical trial · Interventional
LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training
LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
- description
- Will receive 9 telehealth-delivered small group (6-8 participants) sessions (orientation + 8 session DBT skills training protocol) co-facilitated by two skills trainers. Sessions will be 90 minutes each and delivered approximately weekly. Sessions will teach skills from dialectical behavioral therapy (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) adapted for patients with metastatic breast cancer. Sessions follow a standardized structure, including 1) mindfulness practice, 2) home practice and diary card review, 3) learning and practicing new skills, and 4) closing ritual. Participants will have access to a resource library of skills training videos and mindfulness recordings.
- interventionNames
- Behavioral: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Will receive a handout with general support resources available at Hollings Cancer Center.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available