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

The Hong Kong Polytechnic University

Status and phase: Terminated; Phase 2

Conditions: Cancer Survivor; Breast Neoplasms

Treatments: Other: Usual care; Other: Ture self-acupressure; Other: Sham self-acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT04927910

01

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 3 patient groups

True self-acupressure

Experimental group

Description:

1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks.

Treatment:

Other: Ture self-acupressure

Sham self-acupressure

Sham Comparator group

Description:

Same protocol to the true self-acupressure group but on the sham acupoints

Treatment:

Other: Sham self-acupressure

Usual care

Other group

Description:

General advise on managing symptoms provided by healthcare providers

Treatment:

Other: Usual care