LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program.
- Кому может быть актуально
- Состояния в реестре: Survivorship. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer
Обзор
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).
Подробное описание
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.
Вмешательства
- Поведенческое LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
Первичные конечные точки
- PROMIS Depression Short Form (8a) [Срок оценки: Baseline (week 0), post-intervention (week 11), and 1-month follow-up (week 15)]
- PROMIS Anxiety Short Form (7a) [Срок оценки: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
Вторичные конечные точки (12)
- Intolerance of Uncertainty Scale - Short Form (IUS-12) [Срок оценки: 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 [Срок оценки: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- PROMIS Positive Affect Short Form (15a) [Срок оценки: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- Difficulty in Regulating Emotions Scale (DERS-18) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- PROMIS Self-Efficacy for Managing Emotions Short Form (8a) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- PROMIS Emotional Support [Срок оценки: Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15)]
- Group Therapy Experience Scale [Срок оценки: Post-intervention (week 11)]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07539649 · Pro00149650