Decrease Caregiving Fatigue in Group Leaders of a Support Group for Women After Cancer

Официальное название

A Randomized, Controlled Trial to Increase Self-compassion and Decrease Caregiving Fatigue in Group Leaders of a Support Group for Women After Cancer (GLOW) - an Adaption of the Mindful Self-Compassion Program for Healthcare Communities

Обзор

This exploratory study aims to evaluate the effect of a self-compassion training developed for health professionals on leaders of self-help groups. Hypothesis/primary goal: An online group intervention adapted from the "Self-compassion for health-care communities program" validated for health professionals leads to an increase in self-compassion among leaders of cancer self-help groups. Secondary goals: level of self-compassion at the end of the course as a mediator for therapeutic variables after 6 weeks, decrease in caregiver fatigue, secondary traumatic stress/burnout risk, personal distress and sick leave, decrease in fears of self-compassion/compassion for others; increase in mindfulness, self-efficacy, compassion for others and resilience; direct costs; safety; Intervention: Online group intervention: led by a certified mindfulness teacher for Mindful Self-Compassion and additional qualification in Self-Compassion in Healthcare Communities (duration: 6 weekly appointments of 90 min each); control intervention: waiting group

Вмешательства

• Поведенческое Self-compassion training
  Online group intervention: led by a certified mindfulness teacher for mindful self-compassion and additional qualification in self-compassion in healthcare communities (duration: 6 weekly appointments of 90 min each);

Первичные конечные точки

• self-compassion as assessed by Self-compassion scale in german version (SCS-D) [Срок оценки: 6 weeks after baseline]

Вторичные конечные точки (9)

• Decrease in compassion fatigue as assessed by ProQoL [Срок оценки: 12 weeks after baseline]
• secondary traumatic stress/burnout risk as assesd by ProQoL [Срок оценки: 12 weeks after baseline]
• personal distress (PSS-10) [Срок оценки: 12 weeks after baseline]
• decrease in fears of self-compassion (FCS) [Срок оценки: 12 weeks after baseline]
• compassion for others (COS-7) [Срок оценки: 12 weeks after baseline]
• increase in mindfulness (FFMQ) [Срок оценки: 12 weeks after baseline]
• increase in self-efficacy (SWE) [Срок оценки: 12 weeks after baseline]
• increase in resilience (BRS) [Срок оценки: 12 weeks after baseline]
• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: 12 weeks after baseline]

Критерии участия

Критерии включения

• Group leaders of a self-help group for cancer patients
• written informed consent

Критерии исключения

• Medical or mental condition that, in the opinion of the investigator, does not allow the participant to take part in the study or to provide a legally valid signature of the informed consent (e.g. insufficiently controlled pre-existing mental illness or post-traumatic stress disorder)
• Lack of willingness to store and share personal health data as part of the protocol
• Participation in another mindfulness study
• Lack of knowledge of German

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

Профилактика

Центры проведения

Германия · 1 центр

• Comprehensive Cancer Center Würzburg — Würzburg

Идентификаторы

NCT: NCT06937606 · 171/23-am

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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