Breast Cancer Female, Survivorship
Conditions
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.
Interventions
OTHERzhan-zhuang
zhan-zhuang as a fundamental type of qigong
OTHERself-acupressure
Self-acupressure as a common type of traditional Chinese medicine therapies
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 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). |
| Pain(severity and interference) | 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). |
| Sleep disturbance | 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
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | 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 |
| Psychological distress | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the study | After 12 weeks | Eligibility rate |
| Acceptability of the study | 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 |
Countries
China
Outcome results
None listed