Self-acupressure and Zhan Zhuang for Symptom Cluster Management
NCT Number: NCT06497582
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female|Survivorship
Interventions: OTHER: zhan-zhuang|OTHER: self-acupressure
Sponsor: The Hong Kong Polytechnic University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-15
Completion Date: 2025-10-14
Locations: The Hong Kong Polytechnic University (posters, Facebook, WhatsApp groups etc.), Hong Kong, China

Summary:
The proposed study will be a 3-arm, parallel-group randomized controlled trial on the effects of self-acupressure and Zhan-Zhuang for alleviating pain, fatigue, and sleep disturbance in breast cancer survivors. Subjects will include 54 breast cancer survivors who have experienced a moderate level of pain, fatigue and sleep disturbance. All eligible subjects will be randomized into one of the three groups in a 1:1:1 ratio: Zhan Zhuang group, or self-acupressure group, or wait list control group. Subjects in the Zhan-Zhuang group will receive up to 8 weeks of the intervention consisting of a training course over two weeks followed by self-practice for 6 weeks. Those in the self-acupressure group will attend an acupressure training course for two weeks and then, will be asked to practice self-acupressure for 6 weeks. The wait list control group will be provided with delayed self-acupressure or Zhan Zhuang at the end of the study. Outcome assessment will be conducted at baseline, week 8 (post-intervention) and week 12 (4 week follow-up). Primary outcomes include pain, fatigue and sleep disturbance. Secondary outcomes include psychological distress and health-related quality of life. Qualitative data will be collected from selected participants who have received the intervention.

Primary Outcome Measures: Pain(severity and interference), Pain will be measured by the traditional Chinese version of the Brief Pain Inventory. The questionnaire has 9 items assessing pain severity and interference with activities. It is rated using a 0-10 scale (0= no pain and no interference, 10=pain as bad as one can imagine and interferes completely)., Baseline, after 8 weeks, after 12 weeks|Fatigue, Fatigue will be measured by the traditional Chinese version of the Brief Fatigue Inventory. The questionnaire has 9 items assessing pain severity and interference with activities. It is rated using a 0-10 scale (0= no pain and no interference, 10=pain as bad as one can imagine and interferes completely)., Baseline, after 8 weeks, after 12 weeks|Sleep disturbance, Sleep disturbance will be measured by the 19-item traditional Chinese version of the Pittsburgh Sleep Quality Index. The questionnaire consists of seven domains using 19 items: overall sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, day dysfunction due to sleepiness, and use of sleeping medication. The global score is calculated by summing up the scores of seven domains, with a higher score indicating greater sleep disturbance., Baseline, after 8 weeks, after 12 weeks
Secondary Outcome Measures: Psychological distress, Psychological distress will be measured by the 4-item traditional Chinese version of the Patient Health Questionnaire-4. The questionnaire has two subscales, with the 2-item General Anxiety Disorder screener for assessing anxiety and the 2-item Patient Health Questionnaire for assessing depression. Each item is rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day) and the subscale scale ranges from 0 to 6., Baseline, after 8 weeks, after 12 weeks|Health-related quality of life, Health-related quality of life will be measured by the 27-item Traditional Chinese version of the Functional Assessment of Cancer Therapy scale. The questionnaire is a 27-item cancer-specific measure and consists of four domains: physical, social/family, emotional, and functional. Scores of items in specific domains will be created to produce subscale scores and subsequently added to produce a total scale. A higher score reflects better health-related quality of life, Baseline, after 8 weeks, after 12 weeks
Other Outcome Measures: Feasibility of the study, Eligibility rate, After 12 weeks|Feasibility of the study, Recruitment rate, After 12 weeks|Feasibility of the study, Retention rate, After 12 weeks|Feasibility of the study, Reasons for withdrawal from the study as collected from participants through calling them, After 12 weeks|Acceptability of the study, Measured by the 10-item adapted Theoretical Framework of Acceptability Questionnaire (1=disagree, 5=agree). A higher score indicates higher acceptability, After 8 weeks of the intervention|Acceptability of the study, Qualitative in-depth interviews, After 8 weeks of the intervention