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Enrolling by invitation NCT06937606

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

No phase Interventional Caregiver Burden

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-compassion training.
Who it may be relevant to
Registry conditions: Caregiver Burden. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • 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);

Primary outcome measures

  • self-compassion as assessed by Self-compassion scale in german version (SCS-D) [Time frame: 6 weeks after baseline]
Secondary outcome measures (9)
  • Decrease in compassion fatigue as assessed by ProQoL [Time frame: 12 weeks after baseline]
  • secondary traumatic stress/burnout risk as assesd by ProQoL [Time frame: 12 weeks after baseline]
  • personal distress (PSS-10) [Time frame: 12 weeks after baseline]
  • decrease in fears of self-compassion (FCS) [Time frame: 12 weeks after baseline]
  • compassion for others (COS-7) [Time frame: 12 weeks after baseline]
  • increase in mindfulness (FFMQ) [Time frame: 12 weeks after baseline]
  • increase in self-efficacy (SWE) [Time frame: 12 weeks after baseline]
  • increase in resilience (BRS) [Time frame: 12 weeks after baseline]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 12 weeks after baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Germany · 1 center
  • Comprehensive Cancer Center Würzburg — Würzburg

Identifiers

NCT: NCT06937606 · 171/23-am

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗