Self-administered Acupressure to Improve Cancer-related Fatigue Among Cancer Patients Undergoing Chemotherapy

NCT05409352 | Unknown

• 1 other identifier: UW21084
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), quality of life (QoL), cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention. This will be a prospective, assessor-blind, parallel group randomized controlled trial (RCT) that will strictly follow the CONSORT guidelines. A total of 138 patients aged 18 or above with a diagnosis of breast cancer scheduled to commence their first cycle of outpatient adjuvant chemotherapy will be recruited and randomized into self-administered acupressure and aerobic exercise groups. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. The acupressure arm comprises of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained Traditional Chinese Medicine (TCM) practitioner, and self-practice for 12 weeks. The exercise arm consists of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained exercise specialist, and self-practice for 12 weeks. Participants will be instructed to maintain self-practice after the intervention. Intention-to-treat analysis will be performed.

Conditions

Cancer, Breast; Fatigue; Acupressure; Exercise

Keywords

cancer; fatigue; acupressure; exercise; chemotherapy

Outcome Measures

Primary Outcomes (2)

• Fatigue levels

  The Brief Fatigue Inventory (BFI, 9 items) will be used to assess fatigue levels. The first 3 items (fatigue severity subscale) ask patients to describe their current, usual, and worst fatigue in the past 24 hours. The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life. The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).

  post-intervention (the week after the 12-week intervention)

• Fatigue levels

  The Brief Fatigue Inventory (BFI, 9 items) will be used to assess fatigue levels. The first 3 items (fatigue severity subscale) ask patients to describe their current, usual, and worst fatigue in the past 24 hours. The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life. The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).

  one month after the end of all chemotherapy cycles

Secondary Outcomes (8)

• Self-reported sleep quality

  post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles

• Health-related quality of life (QoL)

  post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles

• Self-reported activity levels

  post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles

• Return to work

  one month after the end of all chemotherapy cycles

• Chemotherapy completion

  one month after the end of all chemotherapy cycles

Study Arms (2)

Self-administered acupressure

EXPERIMENTAL

The entire intervention will last 12 weeks, including a one-on-one, 90-min instructional session at week 1 and a one-hour follow-up visit at week 2, which are conducted by a trained traditional Chinese medicine practitioner. Participants will be instructed to perform self-acupressure on the acupoints according to individualized protocol once a day. Participants will be instructed to maintain self-practice after the intervention.

Behavioral: Self-administered acupressure

Aerobic exercise

ACTIVE COMPARATOR

The 12-week aerobic exercise program consists of a one-on-one, 90-min instructional session at week 1 and a one-hour follow-up visit at week 2, which are conducted by a trained exercise specialist. Participants will be advised to perform aerobic exercise of moderate intensity 3 times per week for 30 minutes each time. Accumulating 90 min of exercise per week through more frequent short bouts (e.g. 10-20 min daily) are allowed during the first week of each chemotherapy cycle due to increased symptom burden. Participants will be instructed to maintain self-practice after the intervention.

Behavioral: Aerobic exercise

Interventions

Self-administered acupressure BEHAVIORAL

Participants will receive training of self-acupressure on the 5 standard acupoints by a trained traditional Chinese medicine (TCM) practitioner, have return-demonstration, be assessed by the practitioner with the use of a competency checklist, and be instructed to perform self-acupressure on the standard acupoints once a day. A follow-up visit will be conducted to reinforce learning, in which participants will demonstrate the acupressure technique while the practitioner observes and provides feedback, including suggestions for technique adjustments if necessary. The practitioner will recommend 2 additional acupoints from the list of optional acupoints based on the patients' sensitivity to acupoint stimulation and preference. Daily duration of self-practice will range from 8-10 minutes depending on the semi-individualized protocol (5 standard + 2 optional acupoints).

Self-administered acupressure

Aerobic exercise BEHAVIORAL

Participants will receive verbal and written information from a trained exercise specialist about the specific advice of the desired exercise frequency (3x/week), duration (30 min each time), and intensity (moderate determined by rating of 12 to 14 on the Borg Rating of Perceived Exertion scale). The exercise specialist will demonstrate how to perform walking at moderate intensity indoors and outdoors, followed by return-demonstration of the patient. Education on safety precautions and walk schedule planning will be provided. Competency check will be performed to assess participants' ability to self-monitor and self-regular exercise intensity using Borg Scale. One week after the start of the program, the exercise specialist will conduct a 1-hour follow-up visit to supervise the patient's walking session and assess whether there is any additional advice needed.

Aerobic exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 or above
• with a diagnosis of breast cancer
• scheduled to commence their first cycle of outpatient adjuvant chemotherapy
• have an Eastern Cooperative Oncology Group performance status of 0 or 1
• screened as no contraindications for exercise based on a pre-exercise safety assessment (including aspects of blood results, cardiorespiratory signs and symptoms, metastasis, and variations in cognitive functions)
• written informed consent

You may not qualify if:

• have received/self-administered acupressure or acupuncture in the previous 3 months
• have engaged in \>90 min of moderate intensity aerobic exercise per week in the previous 3 months
• are pregnant or lactating
• have any injury or ulcers around the acupoints
• unable to communicate in Cantonese, Mandarin, or English

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Motor Activity; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Denise Shuk Ting Cheung, PhD

CONTACT

39176673; denisest@hku.hk

Sheung Yiu Chan, MNurs

CONTACT

39176966; chansyc@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed using software that allows for replication by an independent randomizer. To aid allocation concealment, permuted blocks of varying sizes will be used. The randomizer will place the assignment results in sealed, sequentially numbered opaque envelopes and keep a secure copy of the randomization codes. Neither the research assistant (RA) conducting recruitment nor the participants will know the group assignments until the envelope is opened. All outcome assessments will be carried out by research staff blinded to allocation. Neither the specialist delivering exercise intervention nor the TCM practitioner delivering acupressure intervention will be told about the study design or involved in outcome assessment. The statistician performing data analysis will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 8, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 3 years after the manuscript on main findings is published.

Locations

HK (1)