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

April 17, 2025 updated by: Dr. Claudia Loeffler, Wuerzburg University Hospital

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Wuerzburg, Bavaria, Germany, 97080
        • Comprehensive Cancer Center Würzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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);
Behavioral: 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);
No Intervention: waiting list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-compassion as assessed by Self-compassion scale in german version (SCS-D)
Time Frame: 6 weeks after baseline
Determining 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
6 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in compassion fatigue as assessed by ProQoL
Time Frame: 12 weeks after baseline
Professional 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.
12 weeks after baseline
secondary traumatic stress/burnout risk as assesd by ProQoL
Time Frame: 12 weeks after baseline
Professional 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.
12 weeks after baseline
personal distress (PSS-10)
Time Frame: 12 weeks after baseline
The 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.
12 weeks after baseline
decrease in fears of self-compassion (FCS)
Time Frame: 12 weeks after baseline
The 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.
12 weeks after baseline
compassion for others (COS-7)
Time Frame: 12 weeks after baseline
The 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
12 weeks after baseline
increase in mindfulness (FFMQ)
Time Frame: 12 weeks after baseline
The 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).
12 weeks after baseline
increase in self-efficacy (SWE)
Time Frame: 12 weeks after baseline

The 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.
12 weeks after baseline
increase in resilience (BRS)
Time Frame: 12 weeks after baseline
The 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.
12 weeks after baseline
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 12 weeks after baseline
12 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Collaborators

University Hospital Tuebingen
Robert Bosch Medical Center

Investigators

  • Principal Investigator: Claudia Löffler, PD Dr. med., Medizinische klinik und Poliklinik II

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Estimated)

June 16, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 171/23-am

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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