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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Patients Diagnosed With Stage 0-III
• Intervention / Treatment: Behavioral: Shangshou Daoyin Method; Behavioral: Routine Nursing Care

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YUN TZU HUANG, R.N., Ph.D. Candidate; Phone Number: 11335 +886-4-22052121; Email: monkey3618@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shangshou Daoyin Method and Routine Care; The experimental group received instruction in the Shangshou Daoyin Method Exercise and routine care for a total of 20 minutes. Patients were then instructed to perform the Shangshou Guiding Exercise at home at least three times a week for 20 minutes each time, for 12 weeks.	Behavioral: Shangshou Daoyin Method; 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.; Behavioral: Routine Nursing Care; 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.
Placebo Comparator: Routine Care	Behavioral: Routine Nursing Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)	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.	Baseline (Pre-test), Week 4, Week 8, and Week 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30)	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.	Baseline (Pre-test), Week 4, Week 8, and Week 12.
Body Constitution Questionnaire(BCQ)	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.	Baseline (Pre-test), Week 12.

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Breast cancer、Shangshou Daoyin、Sleep quality、Traditional Chinese medicine constitution、quality of life
• Other Study ID Numbers: CMUH114-REC2-225; DMR-115-140 (Other Grant/Funding Number: ChinaMUH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No