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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Psychoeducational Intervention
BehavioralParticipants in the PI group will complete the educational sessions only.
Open Label Placebo
DrugThis group will only take placebo capsules every day.
Psychoeducational Intervention+Placebo
BehavioralThis group will take the placebo capsules every day, as well as completing the educational sessions.
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Psychoeducational InterventionExperimental treatment 1 intervention
Group B: Open Label PlaceboExperimental treatment 1 intervention
Group C: Psychoeducational Intervention+PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov