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

NCT ID: NCT03610243

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2019-05-31

Brief Summary

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.

Detailed 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.

Conditions

Advanced Cancer; Acupressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Self-administered acupressure

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).

Group Type: EXPERIMENTAL

Self-administered acupressure

Intervention Type: BEHAVIORAL

Two 2-hour one-on-one training sessions in patient-centered self-administered acupressure will be provided by trainers in the first week (4 hours) in the patient's home or at the university, depending on his/her preference. From the second to fourth weeks of the intervention, participants will engage in 15 minutes of self-administered acupressure twice a day (for a total of 10.5 hours over the 3 weeks). They will log the frequency of self-practice in a diary and be encouraged to undertake self-practice beyond the 4-week intervention. At weeks 2, 3, and 4, a 1-hour follow-up visit will be conducted by the same team of trainers to reinforce learning and self-practice (for a total of 3 hours over the 3 weeks).

Wait-list control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self-administered acupressure

Two 2-hour one-on-one training sessions in patient-centered self-administered acupressure will be provided by trainers in the first week (4 hours) in the patient's home or at the university, depending on his/her preference. From the second to fourth weeks of the intervention, participants will engage in 15 minutes of self-administered acupressure twice a day (for a total of 10.5 hours over the 3 weeks). They will log the frequency of self-practice in a diary and be encouraged to undertake self-practice beyond the 4-week intervention. At weeks 2, 3, and 4, a 1-hour follow-up visit will be conducted by the same team of trainers to reinforce learning and self-practice (for a total of 3 hours over the 3 weeks).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuk Ting Cheung, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

UW18381

Identifier Type: -

Identifier Source: org_study_id