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

November 27, 2023 updated by: Cheung Shuk-Ting, The University of Hong Kong

Effects of Self-administered Acupressure Versus Aerobic Exercise for Treating Cancer-related Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Equivalence Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cancer-related fatigue (CRF) is recognized as the most frequently reported and distressing symptom among cancer patients. CRF is particularly prevalent in patients undergoing chemotherapy, reported to affect 82-100% of such patients, which in some cases may lead to treatment interruption or discontinuation. If CRF is left untreated during chemotherapy, patients are more likely to have clinically significant CRF that persists for months and years after the treatment. CRF has pervasive impact on a patient's mood, ability to perform daily activities, social relationships, and quality of life (QoL). It also imposes significant financial burden by limiting a patient's ability to work. CRF has been shown to be a risk factor of cancer recurrence and shortened survival. In view of its high prevalence and negative impact, combined with growing survival rates, CRF can be considered as a major public health concern.

Aerobic exercise is the most recommended non-pharmacological strategy for CRF, but it has practical limitations due to a number of barriers to exercise during cancer treatment. Self-administered acupressure is emerging as a promising new strategy for reducing CRF in post-treatment disease-free cancer survivors, but has not been tested rigorously among cancer patients receiving chemotherapy. Both exercise and acupressure are inexpensive and safe self-management strategies that can alleviate CRF and co-occurring cancer symptoms, but as acupressure demands less energy, it may thus be acceptable for a wider range of patients undergoing chemotherapy and experiencing CRF. While previous RCTs on acupressure have focused on post-treatment cancer patients, studies targeting patients undergoing cancer treatment are scarce. A rigorously designed RCT of self-administered acupressure among patients receiving chemotherapy is warranted. To date, no study has examined the equivalence of self-administered acupressure and exercise for reducing CRF. Knowledge of the equivalence of aerobic exercise and acupressure for relieving CRF has important clinical implications that could allow practitioners to target recommendations on the basis of patient preference for a particular type of self-care management.

The primary aim of this study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), QoL, cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Denise Shuk Ting Cheung, PhD
  • Phone Number: 39176673
  • Email: denisest@hku.hk

Study Contact Backup

  • Name: Sheung Yiu Chan, MNurs
  • Phone Number: 39176966
  • Email: chansyc@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Denise Shuk Ting Cheung, PhD
          • Phone Number: 39176673
          • Email: denisest@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. aged 18 or above
  2. with a diagnosis of breast cancer
  3. scheduled to commence their first cycle of outpatient adjuvant chemotherapy
  4. have an Eastern Cooperative Oncology Group performance status of 0 or 1
  5. 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)
  6. written informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Self-administered acupressure
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
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).
Active Comparator: Aerobic exercise
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue levels
Time Frame: post-intervention (the week after the 12-week intervention)
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
Time Frame: one month after the end of all chemotherapy cycles
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported sleep quality
Time Frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
The Pittsburgh Sleep Quality Index (PSQI, 19 items) will be used to assess self-reported sleep quality. Seven component scores are formed: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The scores are summed to produce a global score (0 to 21), with higher scores denoting poorer 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)
Time Frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
The Functional Assessment of Cancer Therapy-Breast (FACT-B) will be used to assess health-related QoL. It has 5 domains: physical, emotional, social/family, and functional well-being. The higher the total scores, the higher levels of QoL.
post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Self-reported activity levels
Time Frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Self-reported activity levels will be measured by the 7-item International Physical Activity Questionnaire short form (IPAQ-SF). Participants will recall types of intensity of physical activity (for estimating total physical activity in metabolic equivalent task-min/week) and sitting time in the last 7 days.
post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Return to work
Time Frame: one month after the end of all chemotherapy cycles
Return to work will be calculated as the percentage of work resumption among those in paid employment at the time of diagnosis and absent from work before the start of treatment.
one month after the end of all chemotherapy cycles
Chemotherapy completion
Time Frame: one month after the end of all chemotherapy cycles
Chemotherapy completion will be calculated as the percentage of patients who would complete chemotherapy without dose adjustments.
one month after the end of all chemotherapy cycles
Objective measure of sleep quality and activity levels
Time Frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Actigraphy will serve as an objective measure of sleep quality and activity levels. The ActiGraph, a non-invasive, wristwatch-sized device, is a widely used, valid, and reliable measure of activity and sleep. Patients will be asked to wear it for three separate 72-hour periods at study entry, post-intervention, one month after the end of all chemotherapy cycles. The parameters of the activity-rest and sleep-wake patterns (e.g., step count, total sleep time, sleep efficiency) will be analyzed by the accompanying software. Participants will record daily activities, bedtimes, and rising times when wearing the device in the diary.
post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Adherence
Time Frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Adherence from study entry to post-intervention and from post-intervention to one month after the end of all chemotherapy cycles will be calculated based on the exercise/acupressure diary. Those who have completed ≥ 75% of prescription will be regarded as adherers.
post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Cognitive impairment
Time Frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Cognitive impairment will be assessed using the Montreal Cognitive Assessment (MoCA) 5-min and the cognitive functioning subscale of European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30).
post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW21084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available on reasonable request as decided by the principal investigator.

IPD Sharing Time Frame

Data will be available for 3 years after the manuscript on main findings is published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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