Self-acupressure and Zhan Zhuang for Symptom Cluster Management

Self-acupressure and Zhan Zhuang for Pain, Fatigue, and Sleep Disturbance in Breast Cancer Survivors: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female; Survivorship
• Intervention / Treatment: Other: zhan-zhuang; Other: self-acupressure

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • The Hong Kong Polytechnic University (posters, Facebook, WhatsApp groups etc.)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zhan-zhuang group; The intervention will last 8 weeks and comprise the following 1) Two sessions of Zhan Zhuang training(2 hours per session/week, totally 4 hours) for 2 weeks. (2) self-practice of zhan-zhuang for 6 weeks (daily, at least 20 mins) at home after passing the evaluation by a Zhan-Zhuang master	Other: zhan-zhuang; zhan-zhuang as a fundamental type of qigong
Experimental: Self-acupressure group; The intervention will last 8 weeks and comprise the following 1) Two sessions of self-acupressure training (2 hours per session/week, totally 4 hours) for 2 weeks. (2) self-practice of acupressure for 6 weeks (daily, around 20 mins) at home after passing the evaluation by a licensed traditional Chinese medicine doctor.	Other: self-acupressure; Self-acupressure as a common type of traditional Chinese medicine therapies
No Intervention: Waitlist control group; Usual care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): October 20, 2024

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No