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

NCT03610243 | Completed

• 1 other identifier: UW18381
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer; Acupressure

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• Pittsburgh Sleep Quality Index (PSQI)

  pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)

• Brief Pain Inventory (BPI)

  pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)

• Hospital Anxiety and Depression Scale (HADS)

  pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)

• Functional Assessment of Cancer Therapy - General (FACT-G)

  re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)

• Symptom cluster severity

  re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)

Study Arms (2)

Self-administered acupressure

EXPERIMENTAL

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).

Behavioral: Self-administered acupressure

Wait-list control

NO INTERVENTION

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

Interventions

Self-administered acupressure 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).

Self-administered acupressure

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000, Hong Kong

Location

Study Officials

• Shuk Ting Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 1, 2018
• Study Start: August 7, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 3, 2022

Record last verified: 2020-04

Locations

HK (1)