Depression Clinical Trials

Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety: a Feasibility Study

NCT03823456

Aim: To assess the acceptability and make estimations about the effectiveness of using self-acupressure to manage insomnia, depression, and anxiety in cancer patients undergoing chemotherapy. Study design: three-arms randomized sham-controlled trial. Participants will be assigned to the true self-acupressure group, sham acupressure group, or enhanced standard care group, with a ratio of 1:1:1 using block randomize. Participants: patients receiving chemotherapy. 114 patients will be recruited to the study. Inclusion criteria: Undergoing chemotherapy currently, Age 20 - 84 years' old, able to read and write Vietnamese, Karnofsky score ≥ 80, Insomnia Severity Index (ISI) score ≥ 11, Anxiety score measured by The Hospital Anxiety and Depression Scale (HADS) ≥ 8 and Depression score measured by HADS ≥ 8 Exclusion criteria: Patients are excluded from the trial if they are unable to understand or cooperate with study procedures, receiving other cancer treatments (e.g., radiotherapy, hormonal therapy) at the same time as receiving chemotherapy and during the period of their involvement in the trial, participating in other research studies which may have interacted with the current trial or affect insomnia, depression, anxiety perception, having difficulties or are unable to practice self-acupressure by themselves, are receiving insomnia or depression/anxiety treatment currently. Interventions Self-administered acupressure training section Participants in the true or sham self-acupressure groups will receive a self-administered acupressure training section based on their group assignment. Then, they will be requested to practice acupressure at home for 4 weeks. Patient leaflet All of the participants in three groups will receive a patient leaflet with tips to manage insomnia, depression, and anxiety. Weekly telephone reminder will be made to follow-up participants in all groups. Outcome measurement The recruitment rate, consent rate, refusal rate, attrition rate, adherence rate will be calculated. The acceptability of the intervention will be measured by the Intervention Rating Profile - 15. The ISI, The HADS, and The Functional Assessment of Cancer Therapy-General will be used to evaluate the effects of self-acupressure on the severity of insomnia, depression, anxiety. Others sleep parameters and adverse events associated with self-acupressure will be recorded.