Breast CancerNCT07911631
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
A study testing Mindful Self-Compassion in people with Breast Cancer, run by Chung Yuan Christian University at 2 sites in Taiwan.
Trial summary
This clinical trial will test a Mindful Self-Compassion (MSC) group program after breast cancer treatment. MSC teaches people to notice difficult feelings and respond to themselves with kindness. The study will enroll 80 adults aged 20 years or older. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mindful Self-Compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTaiwan
- Study dates
- 2 Nov 2026to 20 Sep 2027
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 years or older.
- Physician-diagnosed breast cancer and completion of the primary treatment required for the individual's condition within the 12 months before enrollment. Treatment may include surgery, chemotherapy, or radiotherapy; completion of all treatment types is not required.
- No known distant metastasis at enrollment and no other newly diagnosed cancer since the initial breast cancer diagnosis.
- Aware of the breast cancer diagnosis and able to understand the study information and provide informed consent independently.
- Able to participate in group sessions and complete questionnaires in the language used in the study, and willing to complete baseline, post-program, and three-month follow-up assessments.
Who cannot join
- Significant cognitive, hearing, or communication difficulties that prevent understanding the study or participating in the program despite appropriate assistance.
- Current acute psychiatric symptoms or another unstable physical or psychological condition that makes group participation unsuitable on clinical assessment.
- Acute risk of self-harm or suicide requiring priority intervention.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Cheng Ching General Hospital
Taichung
Dah-Cherng Yeh, MD, +886-4-24632000 ext. 52212, dcyeh55@gmail.com
- Recruiting
Department of Psychology, Chung Yuan Christian University
Taoyuan City, 320314
Pei-Chiung Tu, PhD, +886-32653440, ihpsolab@gmail.com
About this study
Official title: Exploring the Impact of Self-Compassion on Psychological Adjustment and Its Mechanisms Among Breast Cancer Survivors
This clinical trial will test a Mindful Self-Compassion (MSC) group program after breast cancer treatment. MSC teaches people to notice difficult feelings and respond to themselves with kindness.
The study will enroll 80 adults aged 20 years or older. They must have completed their main breast cancer treatment within 12 months before enrollment.
Read more
The main questions are:
- Does MSC support psychological growth after cancer? This includes appreciating life, closer relationships, new possibilities, personal strength, and spiritual changes.
- Does MSC lower emotional distress, including anxiety and depression?
- Do changes in self-compassion, repetitive thoughts, and ways of handling emotions help explain these effects?
Researchers will compare MSC plus usual care with usual care alone during a waiting period. They expect the MSC group to report greater psychological growth and less emotional distress.
Cheng Ching General Hospital will help recruit participants and explain the study before obtaining written consent.
The study will recruit participants in two cohorts of 40 people each. Within each cohort, participants will join the MSC group or waitlist group by chance. Each participant has an equal chance of joining either group. Each cohort will include 20 participants in each group. Across both cohorts, there will be 40 participants in each group.
Participants in the MSC group will:
- Attend one live online 105-minute group session each week for eight weeks.
- Take part in mindfulness exercises, self-compassion practices, writing, and group discussions.
- Be encouraged to practice these skills at home.
Both groups will continue their usual medical and psychological care. Both groups will complete questionnaires at three times:
- Before the eight-week program begins.
- At the end of the eight-week program.
- Three months after the program ends.
The waitlist group will continue usual care without the study's MSC program during these assessments. After completing the three-month follow-up questionnaires, they can choose to attend the MSC program.
Read the detailed description
This study will evaluate an adapted Mindful Self-Compassion (MSC) program and explore potential mechanisms of psychological adjustment among breast cancer survivors. Psychological adjustment encompasses both posttraumatic growth and psychological distress. Posttraumatic growth refers to perceived positive changes arising through coping with cancer, including appreciation of life, relationships with others, new possibilities, personal strength, and spiritual change.
The study will examine whether changes in self-compassion are associated with changes in these adjustment outcomes through cognitive and emotional processes. Proposed mechanisms include intrusive and deliberate rumination, cognitive reappraisal, expressive suppression, and experiential avoidance. Positive and negative dimensions of self-compassion will be scored and analyzed separately.
The study will use a two-arm, parallel-group, individually randomized controlled design. Eighty participants will be recruited in two cohorts of 40. Within each cohort, participants will be individually randomized in a 1:1 ratio to MSC plus usual care or a usual-care waitlist control group, with 20 participants per arm. Across both cohorts, each study arm will include 40 participants.
Cheng Ching General Hospital will assist with participant recruitment. Informed consent procedures will be conducted at the hospital under the responsibility of co-investigator Dr. Dah-Cherng Yeh. The Chung Yuan Christian University research team will coordinate the study and deliver the MSC program online through live videoconferencing.
Personnel independent of recruitment, baseline assessment, and program facilitation will generate computer-based randomization sequences using variable block sizes within each cohort. An independent custodian will retain the allocation information. Assignments will be disclosed only after written informed consent and baseline assessment have been completed.
The adapted MSC program will retain core content involving mindfulness, self-kindness, and common humanity. Adaptations to reduce participation demands include shortening weekly sessions to 105 minutes and omitting the standard midprogram retreat. Two experienced MSC facilitators will review the planned content for consistency with the MSC manual.
A licensed clinical psychologist with MSC-related training and group facilitation experience will lead the online program, supported by a research staff member with clinical psychology training. Each cohort will have one initial MSC course group with a planned enrollment of 20 participants. Facilitators will document attendance, delivered content, adjustments, and participant responses. Participants will be invited to record home-practice frequency, duration, and type. Participants who discontinue sessions will still be invited, with their consent, to complete subsequent assessments.
Participants and facilitators cannot be blinded to group assignment. Post-program questionnaire collection will, where possible, be conducted by research personnel who are not involved in program facilitation. Assessments will occur at baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2). Both groups will use corresponding assessment windows within each cohort.
The waitlist group will continue usual medical and psychological care throughout the controlled assessment period. Necessary treatment will not be restricted in either group. Additional psychological care, participation in mindfulness- or compassion-related programs, and major medical treatment changes will be documented.
After completing T2 for their respective cohort, waitlist participants will be offered an MSC program with the same structure. Data from their subsequent optional MSC participation will not be included in the primary controlled comparison.
A group-by-time mixed-design analysis of variance will examine changes across baseline, post-program, and three-month follow-up assessments. Mediation analyses within the MSC group will explore whether changes in rumination and emotion regulation statistically account for associations between changes in self-compassion and changes in psychological distress and posttraumatic growth. Bootstrap confidence intervals will be used to evaluate indirect effects.
- Conditions
- Breast Cancer
- Being tested
- Mindful Self-Compassion, Usual care
- Keywords
- Mindful Self-Compassion, Posttraumatic Growth, Psychological Distress, Rumination, Emotion Regulation, Breast Cancer Survivors
- Medical subject headings
- Breast Neoplasms, Rumination Syndrome, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self-CompassionBehavioural
Also called MSC
An adapted eight-week Mindful Self-Compassion (MSC) group program for breast cancer survivors, delivered online through live videoconferencing in weekly 105-minute sessions. A licensed clinical psychologist with MSC-related training and group facilitation experience will lead the program, supported by a research staff member with clinical psychology training. The program retains core MSC content involving mindfulness, self-kindness, and common humanity. Activities include guided mindfulness and self-compassion practices, compassionate writing, group sharing, and exercises for responding to difficult emotions and relationships. Participants will receive home-practice guidance and be invited to record practice frequency, duration, and type. To reduce participation demands, sessions are shortened from the standard 150 minutes to 105 minutes, and the midprogram four-hour retreat is omitted.
Usual careOther
Participants in both groups will continue their existing medical and psychological care as clinically indicated. The study will not restrict necessary treatment or assign a standardized usual-care regimen. Additional psychological care, participation in mindfulness- or compassion-related programs, and major medical treatment changes will be documented.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Self-Compassion Plus Usual Care | Experimental | Participants will receive an eight-week Mindful Self-Compassion (MSC) group program through live online videoconferencing, in addition to their usual medical and psychological care. The program consists of one 105-minute session per week, with mindfulness and self-compassion practices, writing, group discussions, and home-practice guidance. Receives: Behavioral: Mindful Self-Compassion; Other: Usual care |
| Usual-Care Waitlist Control | Other | Participants will continue their usual medical and psychological care without receiving the study's Mindful Self-Compassion (MSC) program during the controlled assessment period. After completing the three-month follow-up assessment (T2), participants will be offered the opportunity to attend the same eight-week MSC program. Their subsequent MSC participation will not be included in the primary controlled comparison. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological Distress Measured by the Hospital Anxiety and Depression Scale
Psychological distress will be assessed using the 14-item Hospital Anxiety and Depression Scale (HADS). Each item is scored from 0 to 3. Anxiety and depression items will be combined into a total psychological distress score ranging from 0 to 42, with higher scores indicating greater psychological distress.
Measured: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Posttraumatic Growth Inventory-Short Form Score
Posttraumatic growth will be assessed using a 10-item short form of the Posttraumatic Growth Inventory, with items referring to the breast cancer experience. The measure covers relating to others, new possibilities, personal strength, spiritual change, and appreciation of life. Each item is scored from 0 to 5. Total scores range from 0 to 50, with higher scores indicating greater posttraumatic growth.
Measured: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Secondary outcomes (7)
Change in Positive Self-Compassion Score
Positive self-compassion will be assessed using the six positive-dimension items of the Self-Compassion Scale-Short Form (SCS-SF), covering self-kindness, common humanity, and mindfulness. Items are rated from 1 (almost never) to 5 (almost always). The six item scores will be averaged, yielding a score from 1 to 5. Higher scores indicate greater positive self-compassion. This dimension will be scored and analyzed separately from negative self-compassion.
Measured: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Negative Self-Compassion Score
Negative self-compassion will be assessed using the six negative-dimension items of the Self-Compassion Scale-Short Form (SCS-SF), covering self-judgment, isolation, and over-identification. Items are rated from 1 (almost never) to 5 (almost always). Raw item scores will be averaged without reverse scoring, yielding a score from 1 to 5. Higher scores indicate greater negative self-responding. This dimension will be scored and analyzed separately from positive self-compassion; no combined overall score will be calculated.
Measured: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Intrusive Rumination Measured by the Event Related Rumination Inventory
Intrusive rumination will be assessed using the 10-item intrusive rumination subscale of the Event Related Rumination Inventory (ERRI), referring to the breast cancer experience. Items assess involuntary, recurring thoughts about the experience and are rated from 0 (not at all) to 3 (often). The 10 item scores will be summed, yielding a subscale total from 0 to 30. Higher scores indicate more frequent intrusive rumination. This subscale will be analyzed separately from deliberate rumination.
Measured: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Deliberate Rumination Measured by the Event Related Rumination Inventory
Deliberate rumination will be assessed using the 10-item deliberate rumination subscale of the Event Related Rumination Inventory (ERRI), referring to the breast cancer experience. Items assess intentional reflection on the experience and its meaning and are rated from 0 (not at all) to 3 (often). The 10 item scores will be summed, yielding a subscale total from 0 to 30. Higher scores indicate more frequent deliberate rumination. This subscale will be analyzed separately from intrusive rumination.
Measured: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Cognitive Reappraisal Measured by the Emotion Regulation Questionnaire
Cognitive reappraisal will be assessed using the six-item cognitive reappraisal subscale of the Emotion Regulation Questionnaire (ERQ). Items assess the use of changes in thinking to regulate emotional responses and are rated from 1 (strongly disagree) to 7 (strongly agree). The six item scores will be averaged, yielding a subscale score from 1 to 7. Higher scores indicate more frequent use of cognitive reappraisal. This subscale will be analyzed separately from expressive suppression.
Measured: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Expressive Suppression Measured by the Emotion Regulation Questionnaire
Expressive suppression will be assessed using the four-item expressive suppression subscale of the Emotion Regulation Questionnaire (ERQ). Items assess the tendency to inhibit the outward expression of emotions and are rated from 1 (strongly disagree) to 7 (strongly agree). The four item scores will be averaged, yielding a subscale score from 1 to 7. Higher scores indicate more frequent use of expressive suppression. This subscale will be analyzed separately from cognitive reappraisal.
Measured: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Experiential Avoidance Measured by the Acceptance and Action Questionnaire-II
Experiential avoidance will be assessed using the six-item Chinese version of the Acceptance and Action Questionnaire-II (AAQ-II). Instructions and item contexts refer to cancer- and treatment-related experiences. Items are rated from 1 (never true) to 7 (always true). All items are directly scored and summed, yielding a total from 6 to 42. Higher scores indicate greater experiential avoidance and lower psychological flexibility.
Measured: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start2 Nov 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Yuan Christian University
- Sponsor type
- University, hospital or other
- Collaborators
- Cheng Ching General Hospital, National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, TU, PEI-CHIUNG, Chung Yuan Christian University
- Investigators
- Pei-Chiung Tu, PhD, Principal investigator, Chung Yuan Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911631
- Sponsor's protocol ID
- HP250023
- Other IDs
- NSTC 114-2410-H-033-033-MY2
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data outside the study team due to participant privacy considerations and the scope of informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Self-Compassion on Psychological Adjustment and Its Mechanisms Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07911631
- Acronym / sponsor ID
- HP250023
- Conditions
- Breast Cancer
- Keywords
- Mindful Self-Compassion, Posttraumatic Growth, Psychological Distress, Rumination, Emotion Regulation, Breast Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chung Yuan Christian UniversityUniversity, hospital or other
- Collaborators
- Cheng Ching General Hospital, National Science and Technology Council, Taiwan
- Study start
- 2 Nov 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 3 Nov 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.
This clinical trial will test a Mindful Self-Compassion (MSC) group program after breast cancer treatment. MSC teaches people to notice difficult feelings and respond to themselves with kindness.
The study will enroll 80 adults aged 20 years or older. They must have completed their main breast cancer treatment within 12 months before enrollment.
The main questions are:
- Does MSC support psychological growth after cancer? This includes appreciating life, closer relationships, new possibilities, personal strength, and spiritual changes.
- Does MSC lower emotional distress, including anxiety and depression?
- Do changes in self-compassion, repetitive thoughts, and ways of handling emotions help explain these effects?
Researchers will compare MSC plus usual care with usual care alone during a waiting period. They expect the MSC group to report greater psychological growth and less emotional distress.
Cheng Ching General Hospital will help recruit participants and explain the study before obtaining written consent.
The study will recruit participants in two cohorts of 40 people each. Within each cohort, participants will join the MSC group or waitlist group by chance. Each participant has an equal chance of joining either group. Each cohort will include 20 participants in each group. Across both cohorts, there will be 40 participants in each group.
Participants in the MSC group will:
- Attend one live online 105-minute group session each week for eight weeks.
- Take part in mindfulness exercises, self-compassion practices, writing, and group discussions.
- Be encouraged to practice these skills at home.
Both groups will continue their usual medical and psychological care. Both groups will complete questionnaires at three times:
- Before the eight-week program begins.
- At the end of the eight-week program.
- Three months after the program ends.
The waitlist group will continue usual care without the study's MSC program during these assessments. After completing the three-month follow-up questionnaires, they can choose to attend the MSC program.
Detailed description
This study will evaluate an adapted Mindful Self-Compassion (MSC) program and explore potential mechanisms of psychological adjustment among breast cancer survivors. Psychological adjustment encompasses both posttraumatic growth and psychological distress. Posttraumatic growth refers to perceived positive changes arising through coping with cancer, including appreciation of life, relationships with others, new possibilities, personal strength, and spiritual change.
The study will examine whether changes in self-compassion are associated with changes in these adjustment outcomes through cognitive and emotional processes. Proposed mechanisms include intrusive and deliberate rumination, cognitive reappraisal, expressive suppression, and experiential avoidance. Positive and negative dimensions of self-compassion will be scored and analyzed separately.
The study will use a two-arm, parallel-group, individually randomized controlled design. Eighty participants will be recruited in two cohorts of 40. Within each cohort, participants will be individually randomized in a 1:1 ratio to MSC plus usual care or a usual-care waitlist control group, with 20 participants per arm. Across both cohorts, each study arm will include 40 participants.
Cheng Ching General Hospital will assist with participant recruitment. Informed consent procedures will be conducted at the hospital under the responsibility of co-investigator Dr. Dah-Cherng Yeh. The Chung Yuan Christian University research team will coordinate the study and deliver the MSC program online through live videoconferencing.
Personnel independent of recruitment, baseline assessment, and program facilitation will generate computer-based randomization sequences using variable block sizes within each cohort. An independent custodian will retain the allocation information. Assignments will be disclosed only after written informed consent and baseline assessment have been completed.
The adapted MSC program will retain core content involving mindfulness, self-kindness, and common humanity. Adaptations to reduce participation demands include shortening weekly sessions to 105 minutes and omitting the standard midprogram retreat. Two experienced MSC facilitators will review the planned content for consistency with the MSC manual.
A licensed clinical psychologist with MSC-related training and group facilitation experience will lead the online program, supported by a research staff member with clinical psychology training. Each cohort will have one initial MSC course group with a planned enrollment of 20 participants. Facilitators will document attendance, delivered content, adjustments, and participant responses. Participants will be invited to record home-practice frequency, duration, and type. Participants who discontinue sessions will still be invited, with their consent, to complete subsequent assessments.
Participants and facilitators cannot be blinded to group assignment. Post-program questionnaire collection will, where possible, be conducted by research personnel who are not involved in program facilitation. Assessments will occur at baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2). Both groups will use corresponding assessment windows within each cohort.
The waitlist group will continue usual medical and psychological care throughout the controlled assessment period. Necessary treatment will not be restricted in either group. Additional psychological care, participation in mindfulness- or compassion-related programs, and major medical treatment changes will be documented.
After completing T2 for their respective cohort, waitlist participants will be offered an MSC program with the same structure. Data from their subsequent optional MSC participation will not be included in the primary controlled comparison.
A group-by-time mixed-design analysis of variance will examine changes across baseline, post-program, and three-month follow-up assessments. Mediation analyses within the MSC group will explore whether changes in rumination and emotion regulation statistically account for associations between changes in self-compassion and changes in psychological distress and posttraumatic growth. Bootstrap confidence intervals will be used to evaluate indirect effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Self-Compassion Plus Usual Care | Experimental | Behavioral: Mindful Self-Compassion, Other: Usual careParticipants will receive an eight-week Mindful Self-Compassion (MSC) group program through live online videoconferencing, in addition to their usual medical and psychological care. The program consists of one 105-minute session per week, with mindfulness and self-compassion practices, writing, group discussions, and home-practice guidance. |
| Usual-Care Waitlist Control | Other | Other: Usual careParticipants will continue their usual medical and psychological care without receiving the study's Mindful Self-Compassion (MSC) program during the controlled assessment period. After completing the three-month follow-up assessment (T2), participants will be offered the opportunity to attend the same eight-week MSC program. Their subsequent MSC participation will not be included in the primary controlled comparison. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 20 years or older.
- Physician-diagnosed breast cancer and completion of the primary treatment required for the individual's condition within the 12 months before enrollment. Treatment may include surgery, chemotherapy, or radiotherapy; completion of all treatment types is not required.
- No known distant metastasis at enrollment and no other newly diagnosed cancer since the initial breast cancer diagnosis.
- Aware of the breast cancer diagnosis and able to understand the study information and provide informed consent independently.
- Able to participate in group sessions and complete questionnaires in the language used in the study, and willing to complete baseline, post-program, and three-month follow-up assessments.
Key exclusion criteria (3 listed)
- Significant cognitive, hearing, or communication difficulties that prevent understanding the study or participating in the program despite appropriate assistance.
- Current acute psychiatric symptoms or another unstable physical or psychological condition that makes group participation unsuitable on clinical assessment.
- Acute risk of self-harm or suicide requiring priority intervention.
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 |
|---|---|---|
| Mindful Self-CompassionAlso: MSCAn adapted eight-week Mindful Self-Compassion (MSC) group program for breast cancer survivors, delivered online through live videoconferencing in weekly 105-minute sessions. A licensed clinical psychologist with MSC-related training and group facilitation experience will lead the program, supported by a research staff member with clinical psychology training. The program retains core MSC content involving mindfulness, self-kindness, and common humanity. Activities include guided mindfulness and self-compassion practices, compassionate writing, group sharing, and exercises for responding to difficult emotions and relationships. Participants will receive home-practice guidance and be invited to record practice frequency, duration, and type. To reduce participation demands, sessions are shortened from the standard 150 minutes to 105 minutes, and the midprogram four-hour retreat is omitted. | Behavioural | Mindful Self-Compassion Plus Usual Care |
| Usual careParticipants in both groups will continue their existing medical and psychological care as clinically indicated. The study will not restrict necessary treatment or assign a standardized usual-care regimen. Additional psychological care, participation in mindfulness- or compassion-related programs, and major medical treatment changes will be documented. | Other | Mindful Self-Compassion Plus Usual Care, Usual-Care Waitlist Control |
Primary outcome
Change in Psychological Distress Measured by the Hospital Anxiety and Depression Scale
Time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Psychological distress will be assessed using the 14-item Hospital Anxiety and Depression Scale (HADS). Each item is scored from 0 to 3. Anxiety and depression items will be combined into a total psychological distress score ranging from 0 to 42, with higher scores indicating greater psychological distress.
Change in Posttraumatic Growth Inventory-Short Form Score
Time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Posttraumatic growth will be assessed using a 10-item short form of the Posttraumatic Growth Inventory, with items referring to the breast cancer experience. The measure covers relating to others, new possibilities, personal strength, spiritual change, and appreciation of life. Each item is scored from 0 to 5. Total scores range from 0 to 50, with higher scores indicating greater posttraumatic growth.
7 secondary outcomes
Change in Positive Self-Compassion Score
Time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Negative Self-Compassion Score
Time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Intrusive Rumination Measured by the Event Related Rumination Inventory
Time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Deliberate Rumination Measured by the Event Related Rumination Inventory
Time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Cognitive Reappraisal Measured by the Emotion Regulation Questionnaire
Time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Expressive Suppression Measured by the Emotion Regulation Questionnaire
Time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
Change in Experiential Avoidance Measured by the Acceptance and Action Questionnaire-II
Time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
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 4 Nov 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data outside the study team due to participant privacy considerations and the scope of informed consent.
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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.
Pei-Chiung Tu, PhD principal investigator
Chung Yuan Christian University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self-Compassion in people with Breast Cancer, run by Chung Yuan Christian University at 2 sites in Taiwan.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Contact Pei-Chiung Tu, PhD (+886-935220414, ihpsolab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological Distress Measured by the Hospital Anxiety and Depression Scale (time frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).). 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?
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 4 Nov 2026.