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

2 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Pei-Chiung Tu, PhD
  • Numéro de téléphone: +886-935220414
  • E-mail: ihpsolab@gmail.com

Lieux d'étude

      • Taichung, Taïwan
        • Recrutement
        • Cheng Ching General Hospital
        • Contact:
          • Dah-Cherng Yeh, MD
          • Numéro de téléphone: 52212 +886-4-24632000
          • E-mail: dcyeh55@gmail.com
      • Taoyuan City, Taïwan, 320314
        • Recrutement
        • Department of Psychology, Chung Yuan Christian University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Autres noms:
  • MSC

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.

Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Psychological Distress Measured by the Hospital Anxiety and Depression Scale
Délai: 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
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Positive Self-Compassion Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Pei-Chiung Tu, PhD, Chung Yuan Christian University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 novembre 2026

Achèvement primaire (Estimé)

30 juin 2027

Achèvement de l'étude (Estimé)

20 septembre 2027

Dates d'inscription aux études

Première soumission

28 octobre 2026

Première soumission répondant aux critères de contrôle qualité

28 octobre 2026

Première publication (Réel)

3 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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