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A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer
This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.
PRIMARY OBJECTIVES: I. To establish patient-centeredness by comparing patient ratings of their overall cancer care experience in the clinic versus in the home. II. To establish patient-centeredness by evaluating patient preferences regarding the location of cancer treatment delivery. SAFETY OBJECTIVES: I. To assess the safety of home administered intravenous (IV)/subcutaneous (SQ) drug treatment by a home health provider with remote patient monitoring and Command Center support as measured by the incidence of grade 3+ adverse events at least possibly related to cancer treatment delivery. II. To describe the incidence of acute care visits, emergency room visits, and hospitalizations during the entire study treatment period and by location of cancer treatment delivery (i.e., during in-clinic cancer treatment versus at-home cancer treatment). III. To describe the incidence of avoidable (in the opinion of the treating physician) acute care visits, emergency room visits, and hospitalizations during at-home cancer treatment. SECONDARY OBJECTIVE: I. To evaluate the impact of home cancer treatment delivery on patient-reported function and global health/quality of life, patient-reported symptoms, satisfaction, and clinical outcomes. EXPLORATORY OBJECTIVES: I. To summarize patient perceptions and reasons for patient preferences regarding the location of cancer treatment delivery. II. To describe overall survival. III. To assess the cost outcomes related to patient treatment in the clinic or in the home. OUTLINE: Patients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Mayo Clinic in Florida
Jacksonville, Florida, United States
Start Date
August 27, 2025
Primary Completion Date
August 27, 2028
Completion Date
August 27, 2028
Last Updated
January 28, 2026
38
ESTIMATED participants
Cancer Therapeutic Procedure
DRUG
Cancer Therapeutic Procedure
DRUG
Health Care Delivery
OTHER
Questionnaire Administration
OTHER
Lead Sponsor
Mayo Clinic
Collaborators
NCT04550494
NCT06305598
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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