BridgeMD
New treatment option for Metastatic Cancers
Official title Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
ClinicalTrials.gov ID: NCT06085716
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less...
- 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...
- Have a hemoglobin level of ≥10 g/dL within 2 weeks of enrollment.
You likely can't join if
- Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study medications or their constituents), or conditions making...
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.