Breast Neoplasms, Cancer Survivor
Conditions
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.
Interventions
OTHERTure self-acupressure
8-week intervention of self-acupressure on acupoints
8-week intervention of self-acupressure on non-acupoints
OTHERUsual care
routine care by hospitals
Sponsors
The Huazhong University of Science and Technology Union Shenzhen Hospital
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 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility measure | Immediately after completion of the intervention (T1) | Eligibility rate |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed