Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients

The University of Hong Kong (HKU)

Status: Completed

Conditions: Advanced Cancer; Acupressure

Treatments: Behavioral: Self-administered acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03610243

UW18381

Details and patient eligibility

About

OBJECTIVE: To evaluate the effect of a patient-centered self-administered acupressure intervention on fatigue, sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, psychological distress, and health-related quality of life among Chinese advanced cancer patients.

HYPOTHESIS TO BE TESTED: Upon intervention completion, the intervention group will exhibit lower levels of fatigue, pain, fatigue-sleep disturbance-pain symptom cluster severity, and psychological distress and higher levels of sleep quality and health-related quality of life than the wait-list control group.

DESIGN and SUBJECTS: A randomized wait-list controlled trial with intervention and wait-list control groups. A total of 30 Chinese advanced cancer patients who screen positive for moderate/severe fatigue with symptoms of insomnia and/or pain will be recruited.

STUDY INSTRUMENTS: Chinese versions of the Brief Fatigue Inventory, Pittsburgh Sleep Quality Index, Brief Pain Inventory, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy - General, and a demographic questionnaire.

INTERVENTION: A 4-week patient-centered self-administered acupressure intervention comprising 17.5 hours of individual training and self-practice.

MAIN OUTCOME MEASURES: Primary: fatigue. Secondary: sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, psychological distress, health-related quality of life, actigraphy.

DATA ANALYSIS: Linear mixed-effects models to assess between-group differences in outcome measures post-intervention and changes between data collection points, as well as whether the between-group differences vary across time.

EXPECTED RESULTS: The proposed patient-centered self-administered acupressure intervention is useful for alleviating the fatigue and related symptoms experienced by Chinese advanced cancer patients.

Full description

The prevalence and impacts of fatigue and related symptoms in cancer patients have been clearly demonstrated in the literature, which also emphasizes the need for evidence-based interventions targeting symptom management in such advanced patients. The main challenge is identifying an intervention that is not only effective in managing cancer-related symptoms but is also feasible, acceptable, and safe for this patient group. The proposed study aims to test the effects of a patient-centered self-administered acupressure intervention on fatigue management for Chinese advanced cancer patients using the robust study design of a randomized, wait-list controlled trial.

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chinese ethnicity, 18 years of age or older, and ability to communicate in Cantonese or Putonghua;
2. Advanced-stage cancer diagnosis (i.e., colorectum- stage IV; lung - stage IIIB or IV non-small cell or extensive small cell; breast - stage IV; prostate- stage IV; liver - stage IV);
3. An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1; and
4. Experience of fatigue (rated ≥ 4 on the "fatigue worst" item of the BFI) AND sleep disturbance or pain, or both, in the past week (severity rated ≥ 3 on a 0-10 numeric rating scale)

Exclusion criteria

1. are receiving in-patient hospice care; or
2. are taking any medications for insomnia or depression; or
3. have psychiatric or serious medical disorders that may prevent them from comprehending or performing the intervention; or
4. received acupressure or acupuncture in the previous 3 months; or
5. are pregnant or lactating; or
6. have any injury or ulcers around the acupoints

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Self-administered acupressure

Experimental group

Description:

The proposed self-administered acupressure intervention is patient-centered comprising four pre-selected acupoints that should be applied pressure on by all patients and a list of additional acupoints from which patients can choose two for self-administration according to the personalized recommendations of trainers. In this way, each patient will receive an individualized protocol (four pre-selected and two self-selected acupoints). The intervention consists of: individual participant training (Two 2-hour one-on-one training sessions in week 1), self-practice (15 minutes of self-administered acupressure twice a day), and follow-up visits (a 1-hour follow-up visit at weeks 2, 3, and 4).

Treatment:

Behavioral: Self-administered acupressure

Wait-list control

No Intervention group

Description:

The wait-list control group will be contacted in the third week to attend a health talk unrelated to symptom management.