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NCT07815262
Study on the Efficacy and Safety of "Body-Tuning, Voice-Tuning, Mind-Tuning" Three-Dimensional Integrated Art Therapy in Regulating the Physical-Mental-Social Status of Young and Middle-Aged Breast Cancer Patients After Surgery
Conditions: Breast Cancer
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 66
Sponsor: Keda Yu
Location: Shanghai Cancer Hospital, Fudan University Shanghai Xuhui
Summary
To evaluate the improvement effect of the "Body-Tuning, Voice-Tuning, Mind-Tuning" three-dimensional integrated art therapy on insomnia and physical-mental-social status in breast cancer patients aged ≤45 years, and to explore its positive effects on patients' hope, psychological resilience and social role adaptation, so as to provide a standardized insomnia intervention tool for clinical practice.
Eligibility Criteria
Inclusion Criteria:
* Female, aged ≤ 45 years;
* Histopathologically confirmed diagnosis of breast cancer;
* At least 1 month after completion of postoperative radiotherapy and/or chemotherapy (if applicable);
* ECOG performance status score ≤ 1;
* Good cognitive function and satisfactory compliance;
* Completed physical-mental-social status assessment, with an Insomnia Severity Index (ISI) score ≥ 5;
* Participants voluntarily enrolled in this study and provided written informed consent.
Exclusion Criteria:
* Subjects with a prior definite diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or mental disorders secondary to other medical conditions;
* Complicated with severe physical diseases;
* Received other systematic psychological interventions within the past 3 months;
* Unable to tolerate or cooperate with integrated art therapy, including but not limited to Tai-Chi training, breathing-vocalization training, poetry recitation, storytelling, script reading, etc.;
* Unable to complete follow-up;
* Judged by the researcher to be unsuitable for participation in this study.
Source: ClinicalTrials.gov (NCT07815262). StuddyBuddy aggregates publicly available trial information.