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| ID | Type | Description | Link |
|---|---|---|---|
| DMR-115-140 | Other Grant/Funding Number | ChinaMUH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Routine Care | Placebo Comparator | Routine Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YUN TZU HUANG, R.N., Ph.D. Candidate | Contact | +886-4-22052121 | 11335 | monkey3618@gmail.com |
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| 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. |
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| 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. |