Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Study Overview
Brief 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.
Detailed 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 combination of OLP+PI in these patients will result in a greater reduction of CRF after 3 months and 6 months after treatment
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Have a hemoglobin level of ≥10 g/dL within 2 weeks of enrollment.
- •Be able to understand the description of the study and sign a written informed consent.
- •Have a ECOG performance status score of 0 to 2; and
- •Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or its Houston Area Locations (HALs)
- •Able to read, write and speak English
Exclusion Criteria
- •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.
Arms & Interventions
Open Label Placebo
Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:
Intervention: Open Label Placebo (Drug)
Psychoeducational Intervention
Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:
Intervention: Psychoeducational Intervention (Behavioral)
Psychoeducational Intervention+Placebo
Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:
Intervention: Psychoeducational Intervention+Placebo (Behavioral)
Outcomes
Primary Outcomes
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 year
Secondary Outcomes
No secondary outcomes reported