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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06937606
Acronym
GLOW
Enrollment
64
Registered
2025-04-22
Start date
2024-07-31
Completion date
2026-05-01
Last updated
2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burden

Keywords

self-compassion training, cancer care, empathy fatigue, burnout, resilience

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

Interventions

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);

Sponsors

Robert Bosch Medical Center
CollaboratorOTHER
University Hospital Tuebingen
CollaboratorOTHER
Wuerzburg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
self-compassion as assessed by Self-compassion scale in german version (SCS-D)6 weeks after baselineDetermining self-compassion after the intervention by means of a confirmatory test for group differences in the primary endpoint according to the ITT principle using a linear regression model; instrument: SCS-D

Secondary

MeasureTime frameDescription
Decrease in compassion fatigue as assessed by ProQoL12 weeks after baselineProfessional Quality of Life (ProQOL) is intended for any helper - health care professionals, social service workers, teachers, attorneys, emergency response, etc. Understanding the positive and negative aspects of helping those who experience trauma and suffering can improve your ability to help them and your ability to keep your own balance.
secondary traumatic stress/burnout risk as assesd by ProQoL12 weeks after baselineProfessional Quality of Life (ProQOL) is intended for any helper - health care professionals, social service workers, teachers, attorneys, emergency response, etc. Understanding the positive and negative aspects of helping those who experience trauma and suffering can improve your ability to help them and your ability to keep your own balance.
personal distress (PSS-10)12 weeks after baselineThe Perceived Stress Scale (PSS-10) is a 10-item questionnaire originally developed by Cohen et al. (1983) widely used to assess stress levels in young people and adults aged 12 and above. It evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable and overloading over the previous month.
decrease in fears of self-compassion (FCS)12 weeks after baselineThe FCS-A assesses fear of compassion for self, fear of compassion for others, and fear of compassion from others and. It identifies barriers to giving compassion to oneself (15 items), to others (10 items), and receiving compassion from others (13 items). The items are rated on a five-point Likert scale (0 = Don't agree at all, 4 = Completely agree). The higher the score, the greater the one's fears, blocks and resistances to compassion.
compassion for others (COS-7)12 weeks after baselineThe questionnaire uses a 7 point Likert scale ranging from 1 (not at all true of me) to 7 (very true of me) to capture levels of compassion. Total scores are derived by averaging all item scores. Higher total scores indicate higher levels of compassion for others (strangers). https://doi.org/10.1007/s12144-020-01344-5
increase in mindfulness (FFMQ)12 weeks after baselineThe Five Facet Mindfulness Questionnaire (FFMQ-15) is a 15 question self-report scale that measures mindfulness with regards to thoughts, experiences, and actions in daily life (Baer, Carmody, & Hunsinger, 2012).
increase in self-efficacy (SWE)12 weeks after baselineThe scales can be used to measure beliefs about subjective controllability and competence expectations in various demanding situations, namely at school, in higher education, and in everyday life. The method is primarily intended for use in scientific research. Jerusalem, M. & Schwarzer, R. (1981). Selbstwirksamkeit. WIRK. In R. Schwarzer (Hrsg.) (1986), Skalen zur Befindlichkeit und Persönlichkeit (Forschungsbericht 5. S. 15-28). Berlin: Freie Universität, Institut für Psychologie.
increase in resilience (BRS)12 weeks after baselineThe BRS is a reliable means of assessing resilience as the ability to bounce back or recover from stress and may provide unique and important information. The BRS consists of six items. Items 1, 3, and 5 are phrased positively, while items 2, 4, and 6 are phrased negatively. The BRS is evaluated by recoding items 2, 4, and 6 and calculating the mean value of the six items.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.012 weeks after baseline

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026