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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
21
8-week intervention of self-acupressure on acupoints
8-week intervention of self-acupressure on non-acupoints
routine care by hospitals
The Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, Guangdong, China
Feasibility measure
Eligibility rate
Time frame: Immediately after completion of the intervention (T1)
Feasibility measure
Recruitment rate
Time frame: Immediately after completion of the intervention (T1)
Feasibility measure
Attrition rate
Time frame: Immediately after completion of the intervention (T1)
Feasibility measure
Time to complete the recruitment
Time frame: Immediately after completion of the intervention (T1)
Feasibility measure
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 )
Time frame: Immediately after completion of the intervention (T1)
Acceptability measure
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)
Time frame: Immediately after completion of the intervention (T1)
Arthralgia
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
Time frame: Baseline(T0) and Immediately after completion of the intervention (T1)
Fatigue
The Brief Fatigue Inventory to measure fatigue on a scale of 0=no fatigue, 10=extreme fatigue
Time frame: Baseline(T0) and Immediately after completion of the intervention (T1)
Sleep disturbance
The Pittsburgh Sleep Quality Index (PSQI) to measure sleep disturbance (with different item options) \[a global score ranges from 0 to 21, with a higher score indicating poor sleep quality\]
Time frame: Baseline(T0) and Immediately after completion of the intervention (T1)
Health-related quality of life
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
Time frame: Baseline(T0) and Immediately after completion of the intervention (T1)
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