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

2026年11月2日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Taichung、台湾
        • 招聘中
        • Cheng Ching General Hospital
        • 接触:
      • Taoyuan City、台湾、320314
        • 招聘中
        • Department of Psychology, Chung Yuan Christian University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

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.

其他名称:
  • 海运中心

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.

其他: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.

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Psychological Distress Measured by the Hospital Anxiety and Depression Scale
大体时间: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
大体时间: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).

次要结果测量

结果测量
措施说明
大体时间
Change in Positive Self-Compassion Score
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Pei-Chiung Tu, PhD、Chung Yuan Christian University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年11月2日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年9月20日

研究注册日期

首次提交

2026年10月28日

首先提交符合 QC 标准的

2026年10月28日

首次发布 (实际的)

2026年11月3日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • HP250023
  • NSTC 114-2410-H-033-033-MY2 (其他赠款/资助编号:National Science and Technology Council, Taiwan)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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