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AzTrials

Breast CancerArtRehabNCT07815262

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

A study testing ArtRehab in people with Breast Cancer, run by Keda Yu at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
ArtRehab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
1 Apr 2026to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Cancer Hospital, Fudan University

    Shanghai, Xuhui, 200032

Other trials in China

About this study

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.

Read the detailed description

At present, integrated art therapy interventions for insomnia among young- and middle-aged breast cancer patients not only lack unified standardized implementation protocols, but also have relatively scarce long-term follow-up data for relevant interventions. Meanwhile, targeted clinical application and empirical exploration of such interventions have not yet been carried out in this population. In view of this, this study intends to implement integrated art therapy interventions for this group. While verifying its clinical efficacy, long-term follow-up and data tracking will be performed to fill the research gaps in this field. Therefore, conducting targeted empirical research to explore whether this integrated model can simultaneously relieve insomnia and improve physical-mental-social adaptability among young- and middle-aged breast cancer patients is of great practical and academic significance. It can also provide key practical evidence and theoretical references for the expanded application of this intervention model to other cancer patient populations.

Conditions
Breast Cancer
Being tested
ArtRehab
Keywords
ArtRehab
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ArtRehabDietary supplement

    ArtRehab

Study groups in NCT07815262
Study groupRoleWhat they receive
ArtRehabExperimentalNot described
Receives: Dietary Supplement: ArtRehab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in Insomnia Severity Index (ISI) scores

    Measured: 12month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2026
  2. Study start1 Apr 2026
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07815262
Sponsor's protocol ID
BCR2026-02
Acronym
ArtRehab
Status last verified
Sep 2026
First submitted
17 Aug 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39611900

  • 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.

    PubMed 22091289

  • 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.

  • 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.

  • 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).

  • 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.

    PubMed 38777285

  • 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.

    PubMed 28489508

  • 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.

  • 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.

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

    PubMed 12186352

  • 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).

  • 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.

  • 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.

    PubMed 19626593

  • 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.

    PubMed 23181706

  • 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.

    PubMed 31355357

Questions about this trial

What is this clinical trial studying?

A study testing ArtRehab in people with Breast Cancer, run by Keda Yu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in Insomnia Severity Index (ISI) scores (time frame: 12month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07815262, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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