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Trial Title:
Self-acupressure and Zhan Zhuang for Symptom Cluster Management
NCT ID:
NCT06497582
Condition:
Breast Cancer Female
Survivorship
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
zhan-zhuang
Description:
zhan-zhuang as a fundamental type of qigong
Arm group label:
Zhan-zhuang group
Intervention type:
Other
Intervention name:
self-acupressure
Description:
Self-acupressure as a common type of traditional Chinese medicine therapies
Arm group label:
Self-acupressure group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Hong Kong Polytechnic University (posters, Facebook, WhatsApp groups etc.)
Address:
City:
Hong Kong
Country:
China
Status:
Recruiting
Contact:
Last name:
Huilin Cheng
Phone:
(852)27664771
Start date:
June 15, 2024
Completion date:
October 14, 2025
Lead sponsor:
Agency:
The Hong Kong Polytechnic University
Agency class:
Other
Source:
The Hong Kong Polytechnic University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06497582
