Caregiver BurdenGLOWNCT06937606
Decrease Caregiving Fatigue in Group Leaders of a Support Group for Women After Cancer
A study testing Self-compassion training in people with Caregiver Burden, run by Wuerzburg University Hospital at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Self-compassion training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group leaders of a self-help group for cancer patients
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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;
Read more
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
- Conditions
- Caregiver Burden
- Being tested
- Self-compassion training
- Keywords
- self-compassion training, cancer care, empathy fatigue, burnout, resilience
- Medical subject headings
- Caregiver Burden, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-compassion trainingBehavioural
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);
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion training | Experimental | 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); Receives: Behavioral: Self-compassion training |
| waiting list control | No intervention | waiting list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-compassion as assessed by Self-compassion scale in german version (SCS-D)
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
Measured: 6 weeks after baseline
Secondary outcomes (9)
Decrease in compassion fatigue as assessed by ProQoL
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.
Measured: 12 weeks after baseline
secondary traumatic stress/burnout risk as assesd by ProQoL
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.
Measured: 12 weeks after baseline
personal distress (PSS-10)
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.
Measured: 12 weeks after baseline
decrease in fears of self-compassion (FCS)
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.
Measured: 12 weeks after baseline
compassion for others (COS-7)
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
Measured: 12 weeks after baseline
increase in mindfulness (FFMQ)
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).
Measured: 12 weeks after baseline
increase in self-efficacy (SWE)
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.
Measured: 12 weeks after baseline
increase in resilience (BRS)
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.
Measured: 12 weeks after baseline
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start31 Jul 2024
- Primary completion16 Jun 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch Medical Center, University Hospital Tuebingen
- Responsible party
- Principal investigator, Dr. Claudia Loeffler, Wuerzburg University Hospital
- Investigators
- Claudia Löffler, PD Dr. med., Principal investigator, Medizinische klinik und Poliklinik II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937606
- Sponsor's protocol ID
- 171/23-am
- Acronym
- GLOW
- Status last verified
- Apr 2025
- First submitted
- 23 Sep 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06937606
- Acronym / sponsor ID
- GLOW / 171/23-am
- Conditions
- Caregiver Burden
- Keywords
- self-compassion training, cancer care, empathy fatigue, burnout, resilience
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- Robert Bosch Medical Center, University Hospital Tuebingen
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 16 Jun 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-compassion training | Experimental | Behavioral: Self-compassion trainingOnline 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); |
| waiting list control | No intervention | –waiting list control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Group leaders of a self-help group for cancer patients
- written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-compassion trainingOnline 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); | Behavioural | Self-compassion training |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Löffler, PD Dr. med. principal investigator
Medizinische klinik und Poliklinik II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassion training in people with Caregiver Burden, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-compassion as assessed by Self-compassion scale in german version (SCS-D) (time frame: 6 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.