Breast Cancer FemaleNCT06497582
Self-acupressure and Zhan Zhuang for Symptom Cluster Management
A study testing zhan-zhuang and self-acupressure in people with Breast Cancer Female and Survivorship, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Female, Survivorship
- What is being tested?
- zhan-zhuang and self-acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2024to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Hong Kong Polytechnic University (posters, Facebook, WhatsApp groups etc.)
Hong Kong
About this study
Official title: 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.
- Conditions
- Breast Cancer Female, Survivorship
- Being tested
- zhan-zhuang, self-acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zhan-zhuangOther
zhan-zhuang as a fundamental type of qigong
self-acupressureOther
Self-acupressure as a common type of traditional Chinese medicine therapies
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: self-acupressure |
| Waitlist control group | No intervention | Usual care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Baseline, after 8 weeks, after 12 weeks
Secondary outcomes (2)
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.
Measured: 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
Measured: Baseline, after 8 weeks, after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 May 2024
- Primary completion20 Sep 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497582
- Sponsor's protocol ID
- 04
- Status last verified
- Jun 2025
- First submitted
- 28 May 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-acupressure and Zhan Zhuang for Pain, Fatigue, and Sleep Disturbance in Breast Cancer Survivors: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06497582
- Acronym / sponsor ID
- 04
- Conditions
- Breast Cancer Female, Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zhan-zhuang group | Experimental | Other: zhan-zhuangThe 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 |
| Self-acupressure group | Experimental | Other: self-acupressureThe 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. |
| Waitlist control group | No intervention | –Usual care only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zhan-zhuangzhan-zhuang as a fundamental type of qigong | Other | Zhan-zhuang group |
| self-acupressureSelf-acupressure as a common type of traditional Chinese medicine therapies | Other | Self-acupressure group |
Primary outcome
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).
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).
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.
2 secondary outcomes
Psychological distress
Time frame: Baseline, after 8 weeks, after 12 weeks
Health-related quality of life
Time frame: Baseline, after 8 weeks, after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zhan-zhuang and self-acupressure in people with Breast Cancer Female and Survivorship, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain(severity and interference) (time frame: Baseline, after 8 weeks, after 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.