Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Pei-Chiung Tu, PhD
- Telefonní číslo: +886-935220414
- E-mail: ihpsolab@gmail.com
Studijní místa
-
-
-
Taichung, Tchaj-wan
- Nábor
- Cheng Ching General Hospital
-
Kontakt:
- Dah-Cherng Yeh, MD
- Telefonní číslo: 52212 +886-4-24632000
- E-mail: dcyeh55@gmail.com
-
Taoyuan City, Tchaj-wan, 320314
- Nábor
- Department of Psychology, Chung Yuan Christian University
-
Kontakt:
- Pei-Chiung Tu, PhD
- Telefonní číslo: +886-32653440
- E-mail: ihpsolab@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
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. |
|
Jiný: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Psychological Distress Measured by the Hospital Anxiety and Depression Scale
Časové okno: 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
Časové okno: 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).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Positive Self-Compassion Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Pei-Chiung Tu, PhD, Chung Yuan Christian University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HP250023
- NSTC 114-2410-H-033-033-MY2 (Jiné číslo grantu/financování: National Science and Technology Council, Taiwan)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .