Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13/30).
Be aged 18 years or older.
Be willing to complete in-person or with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas.
Disqualifiers
Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician.
Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
Be pregnant (as documented in chart) or become pregnant while on study.
Trial design
Treatments tested in this trial
- Psychoeducational Intervention
- Open Label Placebo
- Psychoeducational Intervention+Placebo
Treatment groups
240 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov