Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
M.D. Anderson Cancer Center
Summary
To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.
Description
Primary Objectives: 1\. To determine if the combination therapy of PI with 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. We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF compared to PI alone. Secondary Objectives: 1\. 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. We hypothesize that the c…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Be advanced cancer patients or s or have a history of advanced cancer, having fatigue with severity of ≥ 4/10, on a 0-10 scale (Edmonton Symptom Assessment Scale), and presence of fatigue for at least 2 weeks. 2. Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13/30). 3. Be aged 18 years or older. 4. Be willing to complete in-person or with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas. 5. Have a hemo…
Interventions
- BehavioralPsychoeducational Intervention
Participants in the PI group will complete the educational sessions only.
- DrugOpen Label Placebo
This group will only take placebo capsules every day.
- BehavioralPsychoeducational Intervention+Placebo
This group will take the placebo capsules every day, as well as completing the educational sessions.
Location
- MD Anderson Cancer CenterrHouston, Texas