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

NCT07815262 | Active Not Recruiting

• 1 other identifier: BCR2026-02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

ArtRehab

Outcome Measures

Primary Outcomes (1)

• changes in Insomnia Severity Index (ISI) scores

  12month

Study Arms (1)

ArtRehab

EXPERIMENTAL

Dietary Supplement: ArtRehab

Interventions

ArtRehab DIETARY_SUPPLEMENT

ArtRehab

ArtRehab

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keda Yu: lead

Study Sites (1)

Shanghai Cancer Hospital, Fudan University

Shanghai, Xuhui, 200032, China

Location

Related Publications (20)

• Hasan 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 BACKGROUND

• Tehrani 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 BACKGROUND

• 18.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.

  BACKGROUND

• 17.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.

  BACKGROUND

• 16.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).

  BACKGROUND

• Irwin 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 BACKGROUND

• Irwin 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 BACKGROUND

• 13.Tsang, W. W. N., Loo, W. T. Y., Chow, L. W. C., Ng, E. L. Y., Yip, A. Y. S., & Chen, J. (2014). Effect of Tai Chi Chuan on serotonin and cortisol for monitoring stress and quality of life in post-treatment breast cancer patients. Chinese Journal of Breast Disease, 8(4), 266-272.

  BACKGROUND

• 12.Wang, H. Y. (2015). Effect of Tai Chi exercise mode on postoperative anxiety of breast cancer patients. Chinese Journal of Modern Nursing, (28), 3386-3388.

  BACKGROUND

• Harvey AG. A cognitive model of insomnia. Behav Res Ther. 2002 Aug;40(8):869-93. doi: 10.1016/s0005-7967(01)00061-4.

  PMID: 12186352 BACKGROUND

• 10.Daboui, P., Janbabai, G., Akbari, M. E., & Nouri, M. (2022). Effect of Masnavi-based poetry therapy on anxiety, depression and stress of women with breast cancer. Iranian Journal of Psychiatry and Behavioral Sciences, 16(4).

  BACKGROUND

• 9.Yang, J., Xie, X. X., Zhang, Y. H., Chen, J. M., & Chen, J. (2025). A review of the current status and influencing factors of sleep disorders in breast cancer patients. Journal of Contemporary Nurses (Second Half), 32(11), 1-6.

  BACKGROUND

• Vargas S, Wohlgemuth WK, Antoni MH, Lechner SC, Holley HA, Carver CS. Sleep dysfunction and psychosocial adaptation among women undergoing treatment for non-metastatic breast cancer. Psychooncology. 2010 Jun;19(6):669-73. doi: 10.1002/pon.1603.

  PMID: 19626593 BACKGROUND

• Caplette-Gingras A, Savard J, Savard MH, Ivers H. Is insomnia associated with cognitive impairments in breast cancer patients? Behav Sleep Med. 2013;11(4):239-57. doi: 10.1080/15402002.2012.672940. Epub 2012 Nov 26.

  PMID: 23181706 BACKGROUND

• Liou KT, Ahles TA, Garland SN, Li QS, Bao T, Li Y, Root JC, Mao JJ. The Relationship Between Insomnia and Cognitive Impairment in Breast Cancer Survivors. JNCI Cancer Spectr. 2019 Jun 7;3(3):pkz041. doi: 10.1093/jncics/pkz041. eCollection 2019 Sep.

  PMID: 31355357 BACKGROUND

• Vandraas K, Reinertsen KV, Smedsland S, Bohn S, Kiserud C, Falk RS, Lie HC. Fear of cancer recurrence eight years after early-stage breast cancer - results from a national survey. Acta Oncol. 2023 Jun;62(6):635-641. doi: 10.1080/0284186X.2023.2224052. Epub 2023 Jun 19.

  PMID: 37337306 BACKGROUND

• Haque R, Hsu JW, Avila C, Olmstead R, Carroll JE, Irwin MR. Insomnia and Susceptibility to Depressive Symptoms and Fatigue in Diverse Breast Cancer Survivors. J Womens Health (Larchmt). 2021 Nov;30(11):1604-1615. doi: 10.1089/jwh.2019.8135. Epub 2020 Oct 9.

  PMID: 33035108 BACKGROUND

• Fleming L, Randell K, Stewart E, Espie CA, Morrison DS, Lawless C, Paul J. Insomnia in breast cancer: a prospective observational study. Sleep. 2019 Mar 1;42(3):zsy245. doi: 10.1093/sleep/zsy245.

  PMID: 30521041 BACKGROUND

• 2.Gu, Y. H., Liu, Y., Ma, Y. M., et al. (2025). A qualitative study on social role imbalance and its causes in young breast cancer patients. Military Nursing, 42(6).

  BACKGROUND

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director,Department of Breast Surgery,Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 11, 2026
• Study Start: April 1, 2026
• Primary Completion: September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)