- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03610243
Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients
Use of Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients: A Randomized Wait-list Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong, 000
- Queen Mary Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chinese ethnicity, 18 years of age or older, and ability to communicate in Cantonese or Putonghua;
- 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);
- An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1; and
- 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:
- are receiving in-patient hospice care; or
- are taking any medications for insomnia or depression; or
- have psychiatric or serious medical disorders that may prevent them from comprehending or performing the intervention; or
- received acupressure or acupuncture in the previous 3 months; or
- are pregnant or lactating; or
- have any injury or ulcers around the acupoints
Study Plan
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 |
Intervention / Treatment |
---|---|
Experimental: 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). |
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).
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No Intervention: Wait-list control
The wait-list control group will be contacted in the third week to attend a health talk unrelated to symptom management.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Fatigue Inventory (BFI)
Time Frame: post-intervention (T1, 4 weeks later)
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The questionnaire will be used for assessing levels of fatigue.
The first three items (fatigue severity subscale) ask patients to describe their current fatigue, usual fatigue, and worst fatigue in the past 24 hours, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine."
The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life, with 0 = "does not interfere" and 10 = "completely interferes."
The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
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post-intervention (T1, 4 weeks later)
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Brief Fatigue Inventory (BFI)
Time Frame: follow-up (T2, 8 weeks after T0)
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The questionnaire will be used for assessing levels of fatigue.
The first three items (fatigue severity subscale) ask patients to describe their current fatigue, usual fatigue, and worst fatigue in the past 24 hours, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine."
The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life, with 0 = "does not interfere" and 10 = "completely interferes."
The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
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follow-up (T2, 8 weeks after T0)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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This 19-item questionnaire will be used to assess participants' sleep disturbance levels.
The items form seven component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The scores for each component range from 0 to 3 and are summed to produce a global score ranging from 0 to 21, with higher scores denoting poorer sleep quality.
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pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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Brief Pain Inventory (BPI)
Time Frame: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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The pain severity subscale (4 items) will be used to assess participants' pain intensity.
The 4-item subscale assesses pain at its "worst," "least," "average," and "now" using an 11-point response format ranging from 0 ("no pain") to 10 ("pain as bad as you can imagine").
Average scores will be calculated and range from 0 to 10.
The higher scores refer to higher pain intensity.
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pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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This 14-item questionnaire will be used to measure the severity of participants' psychological distress.
Responses are measured on a 4-point scale ranging from 0 ("not present") to 3 ("considerable").
The total score is the sum of the subscale scores (range: 0-42), with a higher score indicating more severe distress.
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pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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The questionnaire consists of 27 items and will be used to assess health-related quality of life.
Respondents have to rate each item with a score between 0 ("not at all") and 4 ("very much").
The subscale scores are added to obtain a total score (range=0-108), with a higher score representing a higher level of HRQOL.
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re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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Symptom cluster severity
Time Frame: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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the average scores of the BFI and BPI severity subscales and the item on overall sleep quality in the PSQI (to be transformed to a 0-10 scale) will be used.
The symptom cluster severity score will be calculated by averaging the fatigue, sleep disturbance, and pain summary scores.
The average severity score range from 0 to 10, with higher scores representing higher severity.
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re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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Actigraphy
Time Frame: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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Actigraphy will serve as an objective measure of activity levels (fatigue) and sleep quality.
Patients will be asked to wear the device for three separate 72-hour periods.
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re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shuk Ting Cheung, PhD, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW18381
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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