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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04927910
• Other study ID #: 01
• Status: Terminated
• Phase: Phase 2
• Start date: June 5, 2021
• Est. completion date: March 29, 2022

Study information

• Verified date: April 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: March 29, 2022
• Est. primary completion date: January 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthralgia
• Breast Neoplasms
• Cancer Survivor
• Dyssomnias
• Parasomnias

Intervention

Other:
• Ture self-acupressure
8-week intervention of self-acupressure on acupoints
• Sham self-acupressure
8-week intervention of self-acupressure on non-acupoints
• Usual care
routine care by hospitals

Locations

Country	Name	City	State
China	The Huazhong University of Science and Technology Union Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The Huazhong University of Science and Technology Union Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measure	Eligibility rate	Immediately after completion of the intervention (T1)
Primary	Feasibility measure	Recruitment rate	Immediately after completion of the intervention (T1)
Primary	Feasibility measure	Attrition rate	Immediately after completion of the intervention (T1)
Primary	Feasibility measure	Time to complete the recruitment	Immediately after completion of the intervention (T1)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)