Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance in Breast Cancer
- Conditions
- Breast NeoplasmsCancer Survivor
- Interventions
- Other: Sham self-acupressureOther: Usual careOther: Ture self-acupressure
- Registration Number
- NCT04927910
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
This study aims to evaluate the feasibility, acceptability and preliminary effects of self-applied acupressure on arthralgia-fatigue-sleep disturbance symptom cluster in breast cancer survivors receiving aromatase inhibitors. This is a preliminary randomized controlled trial, with a three-arm trial design including verum self-acupressure, sham self-acupressure, and usual care. Subjects will include 52 breast cancer survivors who are receiving aromatase inhibitors and have experienced a moderate level of joint pain and at least one of the two symptoms including fatigue and sleep disturbance. Subjects who are randomized to either the verum self-acupressure group (group A) or the sham self-acupressure group (group B) will receive up to 8 weeks of the intervention consisting of two components: (1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. The method and duration of self-acupressure in the sham group will be the same to those in the verum intervention group. The control group will receive usual care. The outcome measures of this study will be related to feasibility, acceptability and preliminary effects of self-acupressure. Individual in-depth interviews will be conducted with selected participants in group A and B to understand their perceptions and perceived effectiveness of the intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 21
Not provided
- Previous receipt of acupuncture and acupressure within the past six months;
- Currently receiving medications (unchanged for 3 month), physical therapy and other complementary and alternative medicines for the treatment of joint pain, fatigue and sleep disturbance;
- Prior joint surgery or fracture during the past six months;
- Mentally incapable of participating in the study (Hong Kong version of Montreal Cognitive Assessment score<22);and
- Inability to perform self-care (Karnofsky Performance Scale score<70).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham self-acupressure Sham self-acupressure Same protocol to the true self-acupressure group but on the sham acupoints Usual care Usual care General advise on managing symptoms provided by healthcare providers True self-acupressure Ture self-acupressure 1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks.
- Primary Outcome Measures
Name Time Method Feasibility measure Immediately after completion of the intervention (T1) Intervention adherence (using a patient-reported diary to document if the patient has completed the intervention daily, experienced any side effects, any other feelings or thoughts )
Acceptability measure Immediately after completion of the intervention (T1) Appropriateness of the intervention components using a self-developed questionnaire (15 close-ended questions mostly on a scale of 1 to 5, higher score indicating higher acceptability and 3 open-ended questions)
- Secondary Outcome Measures
Name Time Method Fatigue Baseline(T0) and Immediately after completion of the intervention (T1) The Brief Fatigue Inventory to measure fatigue on a scale of 0=no fatigue, 10=extreme fatigue
Arthralgia Baseline(T0) and Immediately after completion of the intervention (T1) The Brief Pain Inventory- Short Form to assess joint pain related to aromatase inhibitor-induced arthralgia on a scale of 0=no pain, 10=extreme pain
Sleep disturbance Baseline(T0) and Immediately after completion of the intervention (T1) The Pittsburgh Sleep Quality Index (PSQI) to measure sleep disturbance (with different item options) \[a global score ranges from 0 to 21, with a higher score indicating poor sleep quality\]
Health-related quality of life Baseline(T0) and Immediately after completion of the intervention (T1) The Functional Assessment of Cancer Therapy scale (FACT-G) to measure health-related quality of life on a scale of 0=lower health-related quality of life, 4=higher health-related quality of life
Trial Locations
- Locations (1)
The Huazhong University of Science and Technology Union Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China