Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance in Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance Symptom Cluster in Breast Cancer Survivors Receiving Aromatase Inhibitors

Conditions
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Breast Neoplasms, Cancer Survivor

Intervention / Treatment
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* Other: Ture self-acupressure
* Other: Sham self-acupressure
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Female adult aged 18 and older; Clinical diagnosis of early-stage (Stage I, II, or IIIa), hormone-receptor-positive breast cancer; Completion of surgery, and/or chemotherapy and/or radiotherapy; Currently taking the third generation of AIs (anastrozole, letrozole, or exemestane) for at least 1 month; Based on their self-reports of moderate symptoms of joint pain and fatigue or sleep disturbance; Willing to comply with the intervention protocol, and Being able to communicate in Chinese . Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: True self-acupressure<br>1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. | Other: Ture self-acupressure<br>* 8-week intervention of self-acupressure on acupoints<br>|
| Sham Comparator: Sham self-acupressure<br>Same protocol to the true self-acupressure group but on the sham acupoints | Other: Sham self-acupressure<br>* 8-week intervention of self-acupressure on non-acupoints<br>|
| Other: Usual care<br>General advise on managing symptoms provided by healthcare providers | Other: Usual care<br>* routine care by hospitals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility measure | Eligibility rate | Immediately after completion of the intervention (T1) | 
| Feasibility measure | Recruitment rate | Immediately after completion of the intervention (T1) | 
| Feasibility measure | Attrition rate | Immediately after completion of the intervention (T1) | 
| Feasibility measure | Time to complete the recruitment | 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 ) | 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) | Immediately after completion of the intervention (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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] | 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 | Baseline(T0) and Immediately after completion of the intervention (T1) |