Clinical trial NCT06937606: Decrease Caregiving Fatigue in Group Leaders of a Support Group for Women After Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Caregiver Burden
Keywords: self-compassion training
cancer care
empathy fatigue
burnout
resilience
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: Robert Bosch Medical Center
name: University Hospital Tuebingen
First posted: 2025-04-22
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: self-compassion as assessed by Self-compassion scale in german version (SCS-D)
timeFrame: 6 weeks after baseline
Secondary outcomes:
measure: Decrease in compassion fatigue as assessed by ProQoL
timeFrame: 12 weeks after baseline
measure: secondary traumatic stress/burnout risk as assesd by ProQoL
timeFrame: 12 weeks after baseline
measure: personal distress (PSS-10)
timeFrame: 12 weeks after baseline
measure: decrease in fears of self-compassion (FCS)
timeFrame: 12 weeks after baseline
measure: compassion for others (COS-7)
timeFrame: 12 weeks after baseline
measure: increase in mindfulness (FFMQ)
timeFrame: 12 weeks after baseline
measure: increase in self-efficacy (SWE)
timeFrame: 12 weeks after baseline
measure: increase in resilience (BRS)
timeFrame: 12 weeks after baseline
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 12 weeks after baseline
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Comprehensive Cancer Center Würzburg
state: Bavaria
Study officials:
affiliation: Medizinische klinik und Poliklinik II
name: Claudia Löffler, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: