| Background: A placebo is an inert substance (e.g., sugar pill) or procedure (e.g., sham surgery) that should confer no beneficial effects. Nonetheless, typically, 30-50% of those randomized to placebos report significant benefits. New studies indicate that the use of disclosed or open-label placebos reduces self-reported symptoms among patients with irritable bowel syndrome, migraine attacks, and major depression.;Methods: The investigator conducted a 7-week pilot study to evaluate the feasibility and effects of an open-labeled administration of placebo pills on patient-reported clinical and psychosocial outcomes among cancer survivors seeking relief from cancer-related fatigue. The specific aims of this study were to: (1) assess the feasibility and acceptability of an open-labeled placebo intervention and, (2) explore within-group changes in fatigue-disrupted quality of life and fatigue symptom severity. Utilizing a crossover design, 39 CSs received a persuasive and reasonable rationale about the positive effects of open-label placebos and were randomly assigned to either Group1or Group2. Group1 participants were prescribed placebo pills during the first 21 days of the study while Group2 participants served as controls. After a 7-day "washout" period, Group2 participants were prescribed placebo pills for 21 days while Group1 participants served as controls. The primary outcome for this study was feasibility, as measured by recruitment, enrollment, retention and adherence rates and acceptability. The secondary outcome was changes in fatigue-related quality of life measured by the Multi-dimension Fatigue Symptom Inventory and global fatigue severity measured by the Fatigue Symptom Inventory.;Results: The intervention was found to be a feasible and acceptable treatment for cancer-related fatigue. Within-subjects analyses indicate that participants taking the placebo pills experienced improved fatigue-distressed quality of life (d = 1.00) and global fatigue symptom severity (d = .98) after 21 days and (d= .41, d= .64) after 49 days, respectively.;Conclusion: This pilot trial provides preliminary information on the feasibility and effects of using open-label placebos to treat cancer-related fatigue. However, because the study is ongoing and no between-subjects analyses were conducted, no inference should be made about the effectiveness of a placebo treatment for cancer-related fatigue. |
