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

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Neoplasms; Cancer Survivor
• Intervention / Treatment: Other: Ture self-acupressure; Other: Sham self-acupressure; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • The Huazhong University of Science and Technology Union Shenzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: The Huazhong University of Science and Technology Union Shenzhen Hospital
• Investigators: Principal Investigator: Huilin Cheng, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2021
• Primary Completion (Actual): January 29, 2022
• Study Completion (Actual): March 29, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Skin Diseases; Neoplasms; Sleep Wake Disorders; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Joint Diseases; Musculoskeletal Diseases; Breast Neoplasms; Arthralgia; Dyssomnias; Parasomnias
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No