Self-acupressure and Zhan Zhuang for Symptom Cluster Management

NCT06497582 | Completed

• 1 other identifier: 04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Survivorship

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Psychological distress

  Baseline, after 8 weeks, after 12 weeks

• Health-related quality of life

  Baseline, after 8 weeks, after 12 weeks

Other Outcomes (6)

• Feasibility of the study

  After 12 weeks

• Feasibility of the study

  After 12 weeks

• Feasibility of the study

  After 12 weeks

Study Arms (3)

Zhan-zhuang group

EXPERIMENTAL

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

Self-acupressure group

EXPERIMENTAL

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

Waitlist control group

NO INTERVENTION

Usual care only

Interventions

zhan-zhuang OTHER

zhan-zhuang as a fundamental type of qigong

Zhan-zhuang group

self-acupressure OTHER

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

Self-acupressure group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

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

Hong Kong, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: July 12, 2024
• Study Start: May 15, 2024
• Primary Completion: September 20, 2024
• Study Completion: October 20, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)