Breast Cancer Patients Diagnosed With Stage 0-IIINCT07437144
Exploring the Effects of Shangshou Daoyin Method on Improving Sleep Quality, Quality of Life, and TCM Constitution in Breast Cancer Patients With Insomnia
A study testing Shangshou Daoyin Method and Routine Nursing Care in people with Breast Cancer Patients Diagnosed With Stage 0-III, run by China Medical University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer Patients Diagnosed With Stage 0-III
- What is being tested?
- Shangshou Daoyin Method and Routine Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 31 Dec 2026
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with other cancers.
- Illiterate
- Patients with physical disabilities or inability to perform physical activities.
- Patients diagnosed with mental illness by a physician.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Shangshou Daoyin Method, Routine Nursing Care
- Keywords
- Breast cancer、Shangshou Daoyin、Sleep quality、Traditional Chinese medicine constitution、quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shangshou Daoyin MethodBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Shangshou Daoyin Method and Routine Care | Experimental | 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. Receives: Behavioral: Shangshou Daoyin Method; Behavioral: Routine Nursing Care |
| Routine Care | Placebo comparator | Routine Care Receives: Behavioral: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Pre-test), Week 4, Week 8, and Week 12.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (Pre-test), Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Patients Diagnosed With Stage 0-IIIStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437144
- Sponsor's protocol ID
- CMUH114-REC2-225
- Other IDs
- DMR-115-140
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Shangshou Daoyin Method on Improving Sleep Quality, Quality of Life, and TCM Constitution in Breast Cancer Patients With Insomnia
- ClinicalTrials.gov ID
- NCT07437144
- Acronym / sponsor ID
- CMUH114-REC2-225
- Keywords
- Breast cancer、Shangshou Daoyin、Sleep quality、Traditional Chinese medicine constitution、quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shangshou Daoyin Method and Routine Care | Experimental | Behavioral: Shangshou Daoyin Method, Behavioral: Routine Nursing CareThe 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. |
| Routine Care | Placebo comparator | Behavioral: Routine Nursing CareRoutine Care |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with other cancers.
- Illiterate
- Patients with physical disabilities or inability to perform physical activities.
- Patients diagnosed with mental illness by a physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shangshou Daoyin MethodDuring 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. | Behavioural | Shangshou Daoyin Method and Routine Care |
| Routine Nursing CareResearchers 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. | Behavioural | Routine Care, Shangshou Daoyin Method and Routine Care |
Primary outcome
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.
2 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.
Body Constitution Questionnaire(BCQ)
Time frame: Baseline (Pre-test), Week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Shangshou Daoyin Method and Routine Nursing Care in people with Breast Cancer Patients Diagnosed With Stage 0-III, run by China Medical University Hospital.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact YUN TZU HUANG, R.N., Ph.D. Candidate (+886-4-22052121 ext. 11335, monkey3618@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) (time frame: Baseline (Pre-test), Week 4, Week 8, and Week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.