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

Advanced Cancer Clinical Trial

Official title:

Use of Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients: A Randomized Wait-list Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610243
• Other study ID #: UW18381
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: April 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acupressure
• Advanced Cancer
• Neoplasms

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Fatigue Inventory (BFI)	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).	post-intervention (T1, 4 weeks later)
Primary	Brief Fatigue Inventory (BFI)	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).	follow-up (T2, 8 weeks after T0)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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.	pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Secondary	Brief Pain Inventory (BPI)	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.	pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Secondary	Hospital Anxiety and Depression Scale (HADS)	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.	pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Secondary	Functional Assessment of Cancer Therapy - General (FACT-G)	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.	re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Secondary	Symptom cluster severity	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.	re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Secondary	Actigraphy	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.	re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)