Clinical trial NCT04927910: Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance in Breast Cancer
Official title: Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance Symptom Cluster in Breast Cancer Survivors Receiving Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasms
Cancer Survivor
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The Huazhong University of Science and Technology Union Shenzhen Hospital
First posted: 2021-06-16
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Feasibility measure
timeFrame: Immediately after completion of the intervention (T1)
measure: Feasibility measure
timeFrame: Immediately after completion of the intervention (T1)
measure: Feasibility measure
timeFrame: Immediately after completion of the intervention (T1)
measure: Feasibility measure
timeFrame: Immediately after completion of the intervention (T1)
measure: Feasibility measure
timeFrame: Immediately after completion of the intervention (T1)
measure: Acceptability measure
timeFrame: Immediately after completion of the intervention (T1)
Secondary outcomes:
measure: Arthralgia
timeFrame: Baseline(T0) and Immediately after completion of the intervention (T1)
measure: Fatigue
timeFrame: Baseline(T0) and Immediately after completion of the intervention (T1)
measure: Sleep disturbance
timeFrame: Baseline(T0) and Immediately after completion of the intervention (T1)
measure: Health-related quality of life
timeFrame: Baseline(T0) and Immediately after completion of the intervention (T1)
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: The Huazhong University of Science and Technology Union Shenzhen Hospital
state: Guangdong
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Huilin Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: