This phase II/III trial tests how well a psychoeducational intervention and placebo administration work together for the treatment of cancer related fatigue in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The psychoeducational intervention consists of education, counseling, and self-managed therapies. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness and has been used in previous studies for cancer related fatigue with beneficial effects. Giving psychoeducational interventions in combination with placebo may improve the quality of life better than either the psychoeducational interventions or the placebo alone in patients with metastatic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06085716.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Sriram Yennu
Phone: 713-792-6085
PRIMARY OBJECTIVE:
I. To determine if the combination therapy of psychoeducational intervention (PI) with open-label placebo (OLP) (combination therapy group) is superior to PI alone group in the treatment of cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.
SECONDARY OBJECTIVES:
I. To determine if combination therapy group is superior to PI only group for the treatment of CRF at 3 months and 6 months after treatment.
II. To determine the effects of combination therapy on fatigue-related quality-of-life, mood, sleep-wake activity, cognitive measures, and inflammation.
EXPLORATORY OBJECTIVES:
I. To investigate the additive effect of the combination of OLP and PI in improving cancer related fatigue.
II. To examine the change after 4 weeks of intervention in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) in the combination treatment group versus (vs) OLP alone group.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients receive placebo orally (PO) twice daily (BID) for 4 weeks and complete psychoeducational intervention (PI) training sessions over 1 hour each week for 4 weeks. The PI involves receiving education about managing fatigue and activity level, the importance of sleep/rest, pacing oneself, prioritizing, balancing exercise and rest, and using restorative activity. Patients also undergo blood sample collection on study.
GROUP II: Patients receive placebo PO BID for 4 weeks on study. Patients also undergo blood sample collection on study.
GROUP III: Patients complete PI training sessions over 1 hour each week for 4 weeks. The PI involves receiving education about managing fatigue and activity level, the importance of sleep/rest, pacing oneself, prioritizing, balancing exercise and rest, and using restorative activity. Patients also undergo blood sample collection on study.
After completion of study intervention, patients are followed up at 30 days and at 3 and 6 months.
Trial PhasePhase II/III
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSriram Yennu
