Study of Combination Psychoeducational Therapy and Open Label Placebo for Fatigue in Adults With Metastatic Cancer

What this Trial Is About

Researchers are evaluating whether combining psychoeducational interventions such as education, counseling, and self-managed therapies with an open-label placebo can improve quality of life better than either approach alone in patients with metastatic cancers experiencing cancer-related fatigue CRF. This trial aims to determine if this combination therapy reduces fatigue severity and improves mood, sleep, cognitive function, and inflammation compared to psychoeducational intervention alone. Participants will be randomly assigned to one of three groups psychoeducational intervention only, open-label placebo only, or a combination of both. The psychoeducational intervention involves completing educational sessions either in person or virtually, while the placebo group takes placebo capsules daily. The combination group receives both treatments. The study is open-label, meaning both participants and staff know the assigned treatment. During the study, participants will be assessed using various questionnaires and tests including fatigue scales, quality of life measures, mood and sleep assessments, cognitive tests, activity monitoring, and blood tests for inflammation markers. The main outcome measured is the incidence of adverse events throughout the study, lasting about one year. Participants will be followed for up to six months after treatment to evaluate lasting effects on fatigue and quality of life.

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers