Skip to main content
OpenTrials
Completed

NCT Number: NCT06497582

Self-acupressure and Zhan Zhuang for Symptom Cluster Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Female Survivorship

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zhan-zhuang

Other

zhan-zhuang as a fundamental type of qigong

Self-acupressure

Other

Self-acupressure as a common type of traditional Chinese medicine therapies

Primary outcomes

  1. Pain(severity and interference)

    Time frame: Baseline, after 8 weeks, after 12 weeks

    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).

  2. Fatigue

    Time frame: Baseline, after 8 weeks, after 12 weeks

    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).

  3. Sleep disturbance

    Time frame: Baseline, after 8 weeks, after 12 weeks

    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.

Secondary outcomes

  1. Psychological distress

    Time frame: Baseline, after 8 weeks, after 12 weeks

    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.

  2. Health-related quality of life

    Time frame: Baseline, after 8 weeks, after 12 weeks

    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

Other outcomes

  1. Feasibility of the study

    Time frame: After 12 weeks

    Eligibility rate

  2. Feasibility of the study

    Time frame: After 12 weeks

    Recruitment rate

  3. Feasibility of the study

    Time frame: After 12 weeks

    Retention rate

  4. Feasibility of the study

    Time frame: After 12 weeks

    Reasons for withdrawal from the study as collected from participants through calling them

  5. Acceptability of the study

    Time frame: After 8 weeks of the intervention

    Measured by the 10-item adapted Theoretical Framework of Acceptability Questionnaire (1=disagree, 5=agree). A higher score indicates higher acceptability

  6. Acceptability of the study

    Time frame: After 8 weeks of the intervention

    Qualitative in-depth interviews

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.