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

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Enrolling

Conditions

Cancer, Breast
Acupressure
Fatigue
Exercise

Treatments

Behavioral: Self-administered acupressure
Behavioral: Aerobic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05409352
UW21084

Details and patient eligibility

About

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.

Full 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.

Enrollment

138 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

138 participants in 2 patient groups

Self-administered acupressure
Experimental group
Description:
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.
Treatment:
Behavioral: Self-administered acupressure
Aerobic exercise
Active Comparator group
Description:
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.
Treatment:
Behavioral: Aerobic exercise

Trial contacts and locations

1

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Central trial contact

Sheung Yiu Chan, MNurs; Denise Shuk Ting Cheung, PhD

Data sourced from clinicaltrials.gov

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