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Completed

NCT Number: NCT07415629

Evaluation of a Self-compassion App in People With Cancer: Feasibility, Acceptability and Changes in Well-being

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.

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Key information

Conditions

Cancer Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Emotional Regulation Mental Disorders Neoplasms Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Self-Control Social Behavior Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health Sciences, Health Psychology Section, University Medical Center Groningen

Groningen, 9713 AV, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.
  • Exclusion criteria:
  • 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

Treatment and study plan

A digital self-help self-compassion app intervention

Other

A 6 week self-help self-compassion app intervention providing psychoeducation and brief exercises via the app

Primary outcomes

  1. 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").

  2. 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").

Secondary outcomes

  1. 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.

    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").

  2. 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.

    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").

  3. 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.

    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").

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

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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