Study Comparing Home-Based and Clinic-Based Cancer Therapy in Black Men with Advanced Prostate Cancer
Sponsor: Mayo Clinic
ClinicalTrials ID:NCT07073794
This clinical trial is exploring whether receiving cancer treatment at home is as safe and effective as receiving it in a clinic for Black men with advanced prostate cancer. The study will also look at patient satisfaction and preferences for treatment location.
Patient Parameters
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Program Overview
This study is investigating the effects of receiving cancer treatment at home compared to in a clinic for Black men with prostate cancer that is advanced, has returned after treatment, or has spread to other parts of the body. The trial aims to see if home treatment can reduce stress and improve satisfaction without compromising safety or effectiveness. Patients will first receive treatment in a clinic and then at home, using a system called Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW).
Description
The main goals of this study are to compare how patients feel about their cancer care experience when treatment is given at home versus in a clinic, and to see which location patients prefer for their treatment.
Safety will be assessed by monitoring any serious side effects related to home treatment and tracking visits to the emergency room or hospital. The study will also look at how home treatment affects patients' quality of life, symptoms, and overall health.
Patients will start with standard treatment in a clinic for 6-12 weeks, then switch to home treatment for 12-24 weeks, as long as their cancer does not worsen or they do not experience severe side effects. Any remaining treatment will be completed in the clinic.
Eligibility Criteria
Inclusion Criteria
- Black or African American men aged 18 or older with advanced prostate cancer.
- Currently receiving or planning to start specific cancer treatments, including hormone therapy, chemotherapy, immunotherapy, or bone-strengthening drugs.
- Must be able to receive at least one treatment at home by a nurse.
- Expected to continue treatment for at least 18-24 weeks.
- Live within the service area of the treatment provider.
- Able to provide written consent and follow study procedures.
- Have a performance status score indicating they are fully active or have some limitations but can still care for themselves.
- Able to complete questionnaires with or without help.
- Agree to follow birth control guidelines if they can father children.
Exclusion Criteria
- Currently receiving experimental cancer treatments.
- Hospitalized, except for those in a specific home care program.
- Have other serious health conditions that could interfere with the study.
- Have uncontrolled illnesses like infections or heart problems.
- Have had a severe infection or hospitalization for infection complications in the last 4 weeks.
- Need major surgery during the study.
- Not approved for home treatment due to social factors.
- Previously received home treatment in another similar study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic in Florida | 32224-9980 | Jacksonville | Florida |
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