Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors

November 2, 2026 updated by: TU, PEI-CHIUNG, Chung Yuan Christian University

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • Cheng Ching General Hospital
        • Contact:
      • Taoyuan City, Taiwan, 320314
        • Recruiting
        • Department of Psychology, Chung Yuan Christian University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindful Self-Compassion Plus Usual Care

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.
Behavioral: Mindful Self-Compassion

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.

Other Names:
  • MSC
Other: Usual care

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.
Other: Usual-Care Waitlist Control

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.
Other: Usual care

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).
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.
Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Positive Self-Compassion Score
Time Frame: Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).

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.
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).

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.
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).

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.
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).

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.
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).

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.
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).

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.
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).

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.
Baseline (T0), immediately after the eight-week program (T1), and three months after program completion (T2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chung Yuan Christian University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science and Technology Council, Taiwan
Cheng Ching General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pei-Chiung Tu, PhD, Chung Yuan Christian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HP250023
  • NSTC 114-2410-H-033-033-MY2 (Other Grant/Funding Number: National Science and Technology Council, Taiwan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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