CancerNCT07415629
Evaluation of a Self-compassion App in People With Cancer: Feasibility, Acceptability and Changes in Well-being
A study testing A digital self-help self-compassion app intervention in people with Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
To support patients with cancer with managing psychological distress due to their illness and treatment, a self-help digital Compassionate Mind Training (i.e., Compas-Y App) was developed in co-creation with people with cancer and nurses in oncology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- A digital self-help self-compassion app intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Apr 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 and older;
- Diagnosed with cancer (stage I-III);
- Completed medical treatment in the past 2 years;
- Reporting a reduced well-being (Mental Health Inventory (MHI-5) = <76 score (Kelly et al., 2008) [lower scores indicate worse well-being]);
- Proficient in Dutch;
- willing to try out the app for about 2 hours per week during 6 weeks and fill in the questionnaires for 8-10 weeks;
- Participants should have a smartphone, computer or tablet with internet access for digital intervention and data-collection.
Who cannot join
- 1. Participants have a current psychological or psychiatric treatment outside this study. 2. Insufficient Dutch language skills to follow the group sessions or complete homework exercises
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Health Sciences, Health Psychology Section, University Medical Center Groningen
Groningen, 9713 AV
About this study
To support patients with cancer with managing psychological distress due to their illness and treatment, a self-help digital Compassionate Mind Training (i.e., Compas-Y App) was developed in co-creation with people with cancer and nurses in oncology.
This study will examine : What is the feasibility, acceptability, and effectiveness of Compas-Y app in distressed cancer patients? The reseachers use a multiple baseline design, with a 2-3 week baseline phase and a 6-week intervention phase.
Read more
Adult patients (>= 18 years) will be approached for the study, who finished their medical treatment and who experience a reduced well-being.
To examine the effects of Compas-Y, the researchers will examine changes in self-compassion and self-criticism (primary outcomes) and mindfulness, emotion regulation strategies, and positive and negative affect (secondary outcomes). We will use EMA items to assess momentary levels of these primary and secondary outcomes.
These assessments will be 3 times per week at 7:00 PM, both during the 2-3 week baseline phase ( 6-9 assessments in total) and the 6-week intervention phase (18 times assessments in total).
The expectation is increases in self-compassion, reductions in self-criticism, and improved affect as well as improved mindfulness and emotion regulation. In addition, the expectation is more improvement in outcomes in those patients with greater usage of the app.
- Conditions
- Cancer
- Being tested
- A digital self-help self-compassion app intervention
- Keywords
- Compassion, Self-criticism, App, Emotion Regulation, Intervention, EMA assessment, Self-compassion, Self-help
- Medical subject headings
- Neoplasms, Alzheimer Disease, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A digital self-help self-compassion app interventionOther
A 6 week self-help self-compassion app intervention providing psychoeducation and brief exercises via the app
| Study group | Role | What they receive |
|---|---|---|
| Digital self-help self-compassion app (Compas-Y) | Experimental | 6-week self-help app intervention Receives: Other: A digital self-help self-compassion app intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-compassion
Momentary self-compassion is assessed using ecological momentary assessment (EMA) items. We use five items based on the Sussex-Oxford Compassion for the Self Scale (SOCS-S), with each of the five facets of self-compassion covered by one EMA item: (1) "I'm quick to notice early signs of distress in myself.", (2) "I understand that feeling upset at times is part of human nature.", (3) "I feel kindly towards myself.", (4) "I connect with my own suffering without judging myself.", (5) "I try to look after myself." Items are rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").
Measured: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Self-criticims
Momentary self-criticism is assessed with a single item derived from the Self-Compassion Scale: "I am a bit cold-hearted towards myself when I'm experiencing suffering", rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").
Measured: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Secondary outcomes (3)
Mindfulness
Mindfulness is assessed with two validated momentary assessments items from the platform HowNutsAreTheDutch: (1) "I did activities automatically, without being aware of what I was doing"; (2) "I was easily distracted". Both items are rated on 0-100 scale (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").
Measured: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Affect
Affect is assessed with eight items from the platform HowNutsAreTheDutch. Four items for Positive affect: "I feel excited/relaxed/satisfied/energetic". Four items for Negative affect: "I feel anxious/down/irritable/tired". All items are rated on 0-100 scale (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").
Measured: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Emotion regulation
Emotion Regulation is assessed by four items from existing validated questionnaires adapted for momentary assessment. For all four items the stem is: "Today when unpleasant thoughts came to me .... The items are: "I think that I have to accept the situation (Cognitive Emotion Regulation Questionnaire (CERQ), acceptance subscale), "I think I can learn something from the situation" (CERQ, positive reappraisal subscale), "I am preoccupied with what I think and feel about what I have experienced" (CERQ, rumination subscale), "I try to put them out of my mind" (Multidimensional Experiential Avoidance Questionnaire, avoidance subscale). The four items are rated on 0-100 scale (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").
Measured: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start27 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernst Bohlmeijer, Prof. dr., Principal investigator, Twente University Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415629
- Sponsor's protocol ID
- 17009
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Meta data will be put on the official Groningen University Data Repository to inform researchers about the data and support open science
Publications
Austin J, Drossaert CHC, Schroevers MJ, Sanderman R, Kirby JN, Bohlmeijer ET. Compassion-based interventions for people with long-term physical conditions: a mixed methods systematic review. Psychol Health. 2021 Jan;36(1):16-42. doi: 10.1080/08870446.2019.1699090. Epub 2020 Mar 2.
PubMed 32116052Austin J, Drossaert CHC, van Dijk J, Sanderman R, Borosund E, Mirkovic J, Schotanus-Dijkstra M, Peeters NJ, Van 't Klooster JJR, Schroevers MJ, Bohlmeijer ET. Integrating Top-down and Bottom-up Requirements in eHealth Development: The Case of a Mobile Self-compassion Intervention for People With Newly Diagnosed Cancer. JMIR Cancer. 2022 Aug 1;8(3):e37502. doi: 10.2196/37502.
PubMed 35916691Austin J, Schroevers MJ, Van Dijk J, Sanderman R, Borosund E, Wymenga AMN, Bohlmeijer ET, Drossaert CHC. Compas-Y: A mixed methods pilot evaluation of a mobile self-compassion training for people with newly diagnosed cancer. Digit Health. 2023 Oct 19;9:20552076231205272. doi: 10.1177/20552076231205272. eCollection 2023 Jan-Dec.
PubMed 37868157
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Self-compassion App in People With Cancer: Feasibility, Acceptability and Changes in Well-being
- ClinicalTrials.gov ID
- NCT07415629
- Acronym / sponsor ID
- 17009
- Conditions
- Cancer
- Keywords
- Compassion, Self-criticism, App, Emotion Regulation, Intervention, EMA assessment, Self-compassion, Self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 17 Feb 2026 (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.
To support patients with cancer with managing psychological distress due to their illness and treatment, a self-help digital Compassionate Mind Training (i.e., Compas-Y App) was developed in co-creation with people with cancer and nurses in oncology.
This study will examine : What is the feasibility, acceptability, and effectiveness of Compas-Y app in distressed cancer patients? The reseachers use a multiple baseline design, with a 2-3 week baseline phase and a 6-week intervention phase.
Adult patients (>= 18 years) will be approached for the study, who finished their medical treatment and who experience a reduced well-being.
To examine the effects of Compas-Y, the researchers will examine changes in self-compassion and self-criticism (primary outcomes) and mindfulness, emotion regulation strategies, and positive and negative affect (secondary outcomes). We will use EMA items to assess momentary levels of these primary and secondary outcomes.
These assessments will be 3 times per week at 7:00 PM, both during the 2-3 week baseline phase ( 6-9 assessments in total) and the 6-week intervention phase (18 times assessments in total).
The expectation is increases in self-compassion, reductions in self-criticism, and improved affect as well as improved mindfulness and emotion regulation. In addition, the expectation is more improvement in outcomes in those patients with greater usage of the app.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital self-help self-compassion app (Compas-Y) | Experimental | Other: A digital self-help self-compassion app intervention6-week self-help app intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged 18 and older;
- Diagnosed with cancer (stage I-III);
- Completed medical treatment in the past 2 years;
- Reporting a reduced well-being (Mental Health Inventory (MHI-5) = <76 score (Kelly et al., 2008) [lower scores indicate worse well-being]);
- Proficient in Dutch;
Key exclusion criteria (1 listed)
- 1. Participants have a current psychological or psychiatric treatment outside this study. 2. Insufficient Dutch language skills to follow the group sessions or complete homework exercises
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 |
|---|---|---|
| A digital self-help self-compassion app interventionA 6 week self-help self-compassion app intervention providing psychoeducation and brief exercises via the app | Other | Digital self-help self-compassion app (Compas-Y) |
Primary outcome
Self-compassion
Time frame: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Momentary self-compassion is assessed using ecological momentary assessment (EMA) items. We use five items based on the Sussex-Oxford Compassion for the Self Scale (SOCS-S), with each of the five facets of self-compassion covered by one EMA item: (1) "I'm quick to notice early signs of distress in myself.", (2) "I understand that feeling upset at times is part of human nature.", (3) "I feel kindly towards myself.", (4) "I connect with my own suffering without judging myself.", (5) "I try to look after myself." Items are rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").
Self-criticims
Time frame: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Momentary self-criticism is assessed with a single item derived from the Self-Compassion Scale: "I am a bit cold-hearted towards myself when I'm experiencing suffering", rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").
3 secondary outcomes
Mindfulness
Time frame: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Affect
Time frame: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Emotion regulation
Time frame: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 32116052Austin J, Drossaert CHC, Schroevers MJ, Sanderman R, Kirby JN, Bohlmeijer ET. Compassion-based interventions for people with long-term physical conditions: a mixed methods systematic review. Psychol Health. 2021 Jan;36(1):16-42. doi: 10.1080/08870446.2019.1699090. Epub 2020 Mar 2.
- Background: PubMed 35916691Austin J, Drossaert CHC, van Dijk J, Sanderman R, Borosund E, Mirkovic J, Schotanus-Dijkstra M, Peeters NJ, Van 't Klooster JJR, Schroevers MJ, Bohlmeijer ET. Integrating Top-down and Bottom-up Requirements in eHealth Development: The Case of a Mobile Self-compassion Intervention for People With Newly Diagnosed Cancer. JMIR Cancer. 2022 Aug 1;8(3):e37502. doi: 10.2196/37502.
- Background: PubMed 37868157Austin J, Schroevers MJ, Van Dijk J, Sanderman R, Borosund E, Wymenga AMN, Bohlmeijer ET, Drossaert CHC. Compas-Y: A mixed methods pilot evaluation of a mobile self-compassion training for people with newly diagnosed cancer. Digit Health. 2023 Oct 19;9:20552076231205272. doi: 10.1177/20552076231205272. eCollection 2023 Jan-Dec.
- Individual participant dataSharing planned: Yes. Meta data will be put on the official Groningen University Data Repository to inform researchers about the data and support open science
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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. This study is not recruiting at the moment.
Ernst Bohlmeijer, Prof. dr. principal investigator
Twente University Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A digital self-help self-compassion app intervention in people with Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 7 inclusion and 1 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: finished, as of the sponsor's last update on 17 Feb 2026. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07415629, which also lists 3 linked publications.
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 17 Feb 2026.