Паллиативная помощь и медицина

Абстрактный

Feasibility of a Randomized Controlled Trial of Light Therapy in Cancer Patients with Insomnia

Dev R, Delgado-Guay MO, De La Cruz M, Rhondali W, Hui D and Bruera E

Purpose: The primary objective of our study was to compare bright light therapy versus dim red light for global sleep quality in palliative care patients with cancer. Methods: The study was designed as a randomized, double blind, placebo controlled trial. Patients initiated blinded phase, either daily bright light versus red light placebo, from day 1 to day 14, then proceeded to an open label phase between day 15 to day 28. Results: Of the 319 outpatients assessed for eligibility, 97 patients (30%) fulfilled criteria for the study. Of the 97 patients, only 12 patients (12%) enrolled in the study with the majority unwilling to participate or reported a lack of interest in light therapy. Only 4 patients (33%) completed the trial to the primary endpoint at 2 weeks. Conclusion: At our institution, a randomized controlled trial examining bright light therapy, a potentially safe and effective non-pharmacological approach to treat sleep disturbances, was not feasible for palliative care patients with cancer. Future studies should be tailored to advanced cancer patients who are often frail and have a high symptom burden, incorporate alternative trial designs such as randomization without a placebo arm, and consider integration of home visits or assessment by phone calls to lessen the burden of participation in a clinical trial.