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

NCT04927910 | Terminated Phase 2

• 1 other identifier: 01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Arthralgia

  Baseline(T0) and Immediately after completion of the intervention (T1)

• Fatigue

  Baseline(T0) and Immediately after completion of the intervention (T1)

• Sleep disturbance

  Baseline(T0) and Immediately after completion of the intervention (T1)

• Health-related quality of life

  Baseline(T0) and Immediately after completion of the intervention (T1)

Study Arms (3)

True self-acupressure

EXPERIMENTAL

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

Other: Ture self-acupressure

Sham self-acupressure

SHAM COMPARATOR

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

Other: Sham self-acupressure

Usual care

OTHER

General advise on managing symptoms provided by healthcare providers

Other: Usual care

Interventions

Ture self-acupressure OTHER

8-week intervention of self-acupressure on acupoints

True self-acupressure

Sham self-acupressure OTHER

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

Sham self-acupressure

Usual care OTHER

routine care by hospitals

Usual care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The Huazhong University of Science and Technology Union Shenzhen Hospital: collaborator

Study Sites (1)

The Huazhong University of Science and Technology Union Shenzhen Hospital

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Huilin Cheng, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: June 16, 2021
• Study Start: June 5, 2021
• Primary Completion: January 29, 2022
• Study Completion: March 29, 2022
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)