LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- PROMIS Depression Short Form (8a)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
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.
干预措施: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program (Behavioral)
Usual Care
Will receive a handout with general support resources available at Hollings Cancer Center.
结局指标
主要结局
PROMIS Depression Short Form (8a)
时间窗: Baseline (week 0), post-intervention (week 11), and 1-month follow-up (week 15)
Depression will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater depressive symptomology.
PROMIS Anxiety Short Form (7a)
时间窗: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)
Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (7 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater anxiety symptomology.
次要结局
- Intolerance of Uncertainty Scale - Short Form (IUS-12)(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(Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15))
- PROMIS Positive Affect Short Form (15a)(Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15))
- Difficulty in Regulating Emotions Scale (DERS-18)(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)(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)(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)(Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15))
- PROMIS Self-Efficacy for Managing Emotions Short Form (8a)(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)(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)(Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15))
- PROMIS Emotional Support(Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15))
- Group Therapy Experience Scale(Post-intervention (week 11))
研究者
Kelly Hyland
Assistant Professor
Medical University of South Carolina