Clinical trial · Interventional
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
NCT07815262CI-TRIAL-00126242ArtRehabactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ArtRehab | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ArtRehab
- interventionNames
- Dietary Supplement: ArtRehab
Primary outcomes (1)
- measure
- changes in Insomnia Severity Index (ISI) scores
- timeFrame
- 12month
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (20)
- BACKGROUNDHasan S, Chew KS. Unmet Psychosocial Needs and Quality of Life of Young Women with Breast Cancer: A Scoping Systematic Review. Asian Pac J Cancer Prev. 2024 Nov 1;25(11):3781-3788. doi: 10.31557/APJCP.2024.25.11.3781. PMID 39611900
- BACKGROUNDTehrani AM, Farajzadegan Z, Rajabi FM, Zamani AR. Belonging to a peer support group enhance the quality of life and adherence rate in patients affected by breast cancer: A non-randomized controlled clinical trial. J Res Med Sci. 2011 May;16(5):658-65. PMID 22091289
- BACKGROUND18.Peng, Y. W., Xiang, B. H., & Li, D. M. (2024). An experimental study on integrated art therapy group counseling to improve college students' self-acceptance and hope. University Student Work Research, (01), 179-191.
- BACKGROUND17.Nazemi, M., Ranjbaripour, T., Mashayekh, M., & Yousefi Kashi, A. (2022). Comparison of effectiveness of positive psychotherapy and psychodrama on the hope of breast cancer patients. Clinical Health Psychology, 1(1), 67-79.
- BACKGROUND16.Javidi, N., Khalatbari, G., & Javidi, N. (2022). The effectiveness of psychodrama on reducing generalized anxiety and changing metacognitive beliefs in women with breast cancer. Medbiotech Journal, 6(1).
- BACKGROUNDIrwin MR, Hoang D, Olmstead R, Sadeghi N, Breen EC, Bower JE, Cole S. Tai Chi compared with cognitive behavioral therapy and the reversal of systemic, cellular and genomic markers of inflammation in breast cancer survivors with insomnia: A randomized clinical trial. Brain Behav Immun. 2024 Aug;120:159-166. doi: 10.1016/j.bbi.2024.05.022. Epub 2024 May 20. PMID 38777285
- BACKGROUNDIrwin MR, Olmstead R, Carrillo C, Sadeghi N, Nicassio P, Ganz PA, Bower JE. Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial. J Clin Oncol. 2017 Aug 10;35(23):2656-2665. doi: 10.1200/JCO.2016.71.0285. Epub 2017 May 10. PMID 28489508