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

NCT ID: NCT04927910

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-05
• Study Completion Date: 2022-03-29

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.

Conditions

Breast Neoplasms; Cancer Survivor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

True self-acupressure

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

Group Type: EXPERIMENTAL

Ture self-acupressure

Intervention Type: OTHER

8-week intervention of self-acupressure on acupoints

Sham self-acupressure

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

Group Type: SHAM_COMPARATOR

Sham self-acupressure

Intervention Type: OTHER

8-week intervention of self-acupressure on non-acupoints

Usual care

General advise on managing symptoms provided by healthcare providers

Group Type: OTHER

Usual care

Intervention Type: OTHER

routine care by hospitals

Interventions

Ture self-acupressure

8-week intervention of self-acupressure on acupoints

Intervention Type: OTHER

Sham self-acupressure

8-week intervention of self-acupressure on non-acupoints

Intervention Type: OTHER

Usual care

routine care by hospitals

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Huazhong University of Science and Technology Union Shenzhen Hospital

UNKNOWN

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr CHENG Huilin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huilin Cheng, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Huazhong University of Science and Technology Union Shenzhen Hospital

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id