Clinical trial NCT06497582: Self-acupressure and Zhan Zhuang for Symptom Cluster Management
Official title: Self-acupressure and Zhan Zhuang for Pain, Fatigue, and Sleep Disturbance in Breast Cancer Survivors: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Survivorship
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* a female adult aged 18 and older;
* a diagnosis of early-stage (Stage I, II, or III) breast cancer;
* completion of surgery, and/or chemotherapy and/or radiotherapy;
* have at least a moderate level of pain, fatigue and sleep disturbance as measured on 0-10 numerical rating scales, with a score of ≥ 3 for each symptom during the past one month;
* willing to use WhatsApp messenger for follow-ups;
* being able to communicate in Chinese

Exclusion Criteria:

* prior use of acupuncture, acupressure, Zhan Zhuang, or other types of Zhan Zhuang within the past three months;
* currently receiving progressive muscle relaxation, mindfulness-based stress reduction, and other body mind exercise (e.g. yoga) for the treatment of pain, fatigue, and sleep disturbance;
* mentally incapable of participating in the study as indicated by the Hong Kong version of Montreal Cognitive Assessment score;
* inability to perform self-care as indicated by the Karnofsky Performance Scale score\<70

Primary outcomes:
measure: Pain(severity and interference)
timeFrame: Baseline, after 8 weeks, after 12 weeks
measure: Fatigue
timeFrame: Baseline, after 8 weeks, after 12 weeks
measure: Sleep disturbance
timeFrame: Baseline, after 8 weeks, after 12 weeks
Secondary outcomes:
measure: Psychological distress
timeFrame: Baseline, after 8 weeks, after 12 weeks
measure: Health-related quality of life
timeFrame: Baseline, after 8 weeks, after 12 weeks
Other outcomes:
measure: Feasibility of the study
timeFrame: After 12 weeks
measure: Feasibility of the study
timeFrame: After 12 weeks
measure: Feasibility of the study
timeFrame: After 12 weeks
measure: Feasibility of the study
timeFrame: After 12 weeks
measure: Acceptability of the study
timeFrame: After 8 weeks of the intervention
measure: Acceptability of the study
timeFrame: After 8 weeks of the intervention
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University (posters, Facebook, WhatsApp groups etc.)
Study officials:
References: