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NCT07911631
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Conditions: Breast Cancer
Sex: All
Ages: 20 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Chung Yuan Christian University
Location: Cheng Ching General Hospital Taichung
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. 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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07911631). StuddyBuddy aggregates publicly available trial information.