Virtual Group Resilient Living Program For Patients Living With Advanced Cancer

Обзор

This study is a prospective, minimal risk, non-randomized, single-arm study to determine feasibility and assess effectiveness of a Virtual Group Resilient Living Program (RLP) on anxiety, stress, quality of life (QOL), coping, and fatigue among patients with advanced cancer. The group RLP is a psychosocial intervention that consists of a total of 7 weekly sessions in which the interventionalist teaches the patients techniques on stress management and building resilience (mindfulness, uplifting emotions, reframe experiences through principles of gratitude, compassion, acceptance, meaning, and forgiveness). The group setting allows for support and connection amongst the patients, providing further support and motivation to practice the principles of the program.

Вмешательства

• Поведенческое Virtual Group Resilient Living Program (RLP)
  The Resilient Living Program (RLP) is a virtual program consisting of online modules and virtual training sessions focused on techniques for managing stress and building resilience (mindful presence, uplifting emotions, and reframing experiences through principles of gratitude, compassion, acceptance, meaning, and forgiveness).
• Другое Survey Completion
  Participants will complete study-related surveys.

Первичные конечные точки

• Enrollment Feasibility [Срок оценки: Up to 1 year]
• Completion Feasibility [Срок оценки: Up to 1 year]
• Acceptability - Was it Worth it (WIWI) [Срок оценки: After week 7 session]

Вторичные конечные точки (5)

• Change in Anxiety - GAD-7 [Срок оценки: Baseline, after week 7 session, 30 days after week 7 session]
• Change in Stress - PSS [Срок оценки: Baseline, after week 7 session, 30 days after week 7 session]
• Change in Quality of Life (QoL) - FACT-G [Срок оценки: Baseline, after week 7 session, 30 days after week 7 session]
• Change in Coping - Brief COPE [Срок оценки: Baseline, after week 7 session, 30 days after week 7 session]
• Change in Fatigue - PROMIS-Fatigue [Срок оценки: Baseline, after week 7 session, 30 days after week 7 session]

Критерии участия

Критерии включения

• English fluency
• Diagnosis of advanced (stage III/IV) malignancy
• Baseline distress score ≥ 4/10. Patients can answer questions orally rather than complete worksheet, if applicable
• Life expectancy of ≥ 6 months
• Provide informed consent
• Ability to complete questionnaire(s) by themselves or with assistance
• Has a reliable internet connection
• Has the ability to utilize technology to watch online modules, \& participate in virtual sessions

Критерии исключения

• As determined through self-report, those diagnosed with a history of a psychotic episode ≤ 5 years
• All psychological co-morbidities such as a history of untreated schizophrenia, \& bipolar disease
• A diagnosis of severe cognitive impairment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT07659158 · MC250905 · 25-011765 · MNCCTN043

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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