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
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.
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. ;
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