Clinical trial NCT03610243: Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients
Official title: Use of Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients: A Randomized Wait-list Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Acupressure
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
First posted: 2018-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Brief Fatigue Inventory (BFI)
timeFrame: post-intervention (T1, 4 weeks later)
measure: Brief Fatigue Inventory (BFI)
timeFrame: follow-up (T2, 8 weeks after T0)
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
measure: Brief Pain Inventory (BPI)
timeFrame: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: pre-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
measure: Symptom cluster severity
timeFrame: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
measure: Actigraphy
timeFrame: re-intervention (T0, baseline); post-intervention (T1, 4 weeks later); follow-up (T2, 8 weeks after T0)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Shuk Ting Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: