LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program.
- Who it may be relevant to
- Registry conditions: Survivorship. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer
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).
Detailed 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.
Interventions
- Behavioral LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
Primary outcome measures
- PROMIS Depression Short Form (8a) [Time frame: Baseline (week 0), post-intervention (week 11), and 1-month follow-up (week 15)]
- PROMIS Anxiety Short Form (7a) [Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
Secondary outcome measures (12)
- Intolerance of Uncertainty Scale - Short Form (IUS-12) [Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale [Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- PROMIS Positive Affect Short Form (15a) [Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- Difficulty in Regulating Emotions Scale (DERS-18) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)]
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)]
- DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS) [Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE) [Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- PROMIS Self-Efficacy for Managing Emotions Short Form (8a) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)]
- PROMIS Self-Efficacy for Managing Symptoms Short Form (8a) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 1 month follow-up (week 15)]
- Functional Assessment of Cancer Therapy - Breast (FACT-B) [Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- PROMIS Emotional Support [Time frame: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- Group Therapy Experience Scale [Time frame: Post-intervention (week 11)]
Eligibility criteria
Inclusion criteria
- 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
- be > 18 years of age
- be able to understand, speak, and read English
- be able to provide informed consent.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07539649 · Pro00149650