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NCT Number: NCT07437144

Exploring the Effects of Shangshou Daoyin Method on Improving Sleep Quality, Quality of Life, and TCM Constitution in Breast Cancer Patients With Insomnia

Breast cancer patients often experience insomnia and physical imbalances during and after treatment, indirectly affecting their quality of life. Therefore, the sleep quality, quality of life, and TCM constitution of breast cancer patients need to be taken seriously. Oral sleep aids are prone to causing additional side effects; therefore, in addition to medication, non-pharmacological therapies can be used to alleviate the insomnia caused by breast cancer patients, thereby improving their quality of life. Because guided exercises are simple to learn, gentle, safe, and can be performed without time constraints, clinicians can apply them to the care of breast cancer patients. It is hoped that the results of this study can provide a reference for other related research.

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Key information

Conditions

Breast Cancer Patients Diagnosed With Stage 0-III

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Breast cancer patients aged ≥20 years diagnosed with 0-III cancer, without any signs of metastasis or recurrence
Cases who have completed surgery, targeted therapy, chemotherapy, or radiotherapy at least 3 months ago.
Cases who have started taking anti-hormone inhibitors and traditional Chinese medicine for 3 months.
Pittsburgh Sleep Quality Scale (CPSQI) score ≥5.
Cases who are willing to participate and complete the consent form.

Exclusion criteria

Patients with other cancers.
Illiterate
Patients with physical disabilities or inability to perform physical activities.
Patients diagnosed with mental illness by a physician.

Treatment and study plan

Shangshou Daoyin Method

Behavioral

During the trial, the intervention involved performing Shangshou Daoyin Method exercises at least three times a week,while the control group received only routine care for 12 weeks. During the intervention, daily reminders were sent via Line (to wear an activity tracker 30 minutes before bedtime to monitor sleep time and efficiency, and to review the sleep log every morning), and weekly reminders were sent to submit sleep time, efficiency, and seven-day sleep log results.

Routine Nursing Care

Behavioral

Researchers provided individualized routine care and administered activity recorders, along with paper logbooks. Participants were instructed on how to fill out the logbook and use the activity recorder. After joining the official Line group, participants were instructed on how to use Line. In addition to daily reminders and support via Line, participants were asked to wear the activity recorder 30 minutes before bedtime and to regularly submit data via Line.

Primary outcomes

Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)

Time frame: Baseline (Pre-test), Week 4, Week 8, and Week 12.

Primarily measures the subject's sleep quality over the past month. The questionnaire includes seven dimensions: subjective sleep quality, sleep latency, total sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.

Scores for the seven dimensions range from 0 to 3, with a total score from 0 to 21. Higher scores indicate poorer sleep quality. A total score of 5 or less indicates good sleep quality, while a total score greater than 5 indicates poor sleep quality.

Secondary outcomes

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30)

Time frame: Baseline (Pre-test), Week 4, Week 8, and Week 12.

The primary measure was the degree of distress experienced by participants due to cancer-related issues. The questionnaire consisted of 30 questions across 5 functional dimensions, 9 symptom dimensions, and 1 overall quality of life dimension, for a total of 15 dimensions. The total score ranged from 0 to 100. Higher scores on the functional and overall quality of life dimensions indicated a better quality of life; higher scores on the symptom dimensions indicated more severe symptom problems.
Body Constitution Questionnaire(BCQ)

Time frame: Baseline (Pre-test), Week 12.

The primary objective was to measure the occurrence of subjective physical symptoms reported by the subjects over the past month. The scale consisted of three independent body mass scales: a 16-item phlegm-dampness stagnation scale, a 19-item yin-blood deficiency scale, and a 19-item yang-qi deficiency scale. Since some items were shared across the three scales, the total number of items was 44. A five-point Likert scale was used for scoring; higher scores indicated a stronger affinity for that constitution type. A total score of ≥27 on the phlegm-dampness stagnation scale indicated a phlegm-dampness stagnation constitution; a total score of ≥30 on the yin-blood deficiency scale indicated a yin-blood deficiency constitution; and a total score of ≥31 on the yang-qi deficiency scale indicated a yang-qi deficiency constitution. If the scores on all three scales did not reach the cut-point, the subject was classified as having a balanced constitution.

Study contacts

Contact information is provided by the study sponsor or research team.

YUN TZU HUANG, R.N., Ph.D. Candidate

CONTACT

[email protected]

+886-4-22052121 ext. 11335

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 27, 2026
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.