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Enrolling by Invitation

NCT Number: NCT06937606

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Cancer Center Würzburg

Würzburg, Bavaria, 97080, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Compassion Training

Behavioral

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 outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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).

  7. 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.

  8. 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.

  9. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 12 weeks after baseline

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • Robert Bosch Medical Center
  • University Hospital Tuebingen

Registry information

Official study 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

Acronym: GLOW

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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