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Not yet recruitingNCT07437144Updated Feb 27, 2026

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

An interventional study of Shangshou Daoyin Method and Routine Nursing Care in Breast Cancer Patients Diagnosed With Stage 0-III, sponsored by China Medical University Hospital. Not yet recruiting. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
20 Years and older
Sex
Female
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Study summary

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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Conditions studied

  • Breast Cancer Patients Diagnosed With Stage 0-III

Keywords

  • Breast cancer、Shangshou Daoyin、Sleep quality、Traditional Chinese medicine constitution、quality of life
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In context

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • 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 · Behavioral: Routine Nursing Care

  • Placebo comparator
    Routine Care

    Routine Care

    Behavioral: Routine Nursing Care

Interventions

  • BehavioralShangshou 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.

  • BehavioralRoutine 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.

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What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07437144
Lead sponsor
China Medical University Hospital
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Mar 2, 2026 (estimated)
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

YUN TZU HUANG, R.N., Ph.D. Candidate
Contact
monkey3618@gmail.com
+886-4-22052121 ext. 11335

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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