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
Summary
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.
Detailed description
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.
Arms & interventions
- DrugCancer Therapeutic Procedure
Given standard of care cancer treatment in clinic
- DrugCancer Therapeutic Procedure
Given standard of care cancer treatment in home
- OtherHealth Care Delivery
Receive in home cancer treatment with CCBW
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Patient rating of overall cancer care experience - CAHPS
Patient rating of their overall cancer care experience after 12 weeks of at-home cancer treatment will be compared to the same rating after 6 or 12 weeks of in-clinic cancer treatment. Will be assessed using patient ratings from a single item from the Consumer Assessment of Healthcare Providers (CAHPS). Participants will rate "your overall cancer care experience" on a 0 to 10 scale where 0 is the worst experience possible and 10 is the best experience possible.
Time frame: Up to 48 weeks
Patient preferences regarding the location of cancer treatment delivery
Will be assessed by a single item asking patients to rate their preferred location for cancer treatment delivery on a 1 to 7 scale: 1=strongly prefer in clinic, 2=moderately prefer in clinic, 3=slightly prefer in clinic, 4=no preference, 5=slightly prefer at home, 6=moderately prefer at home, 7=strongly prefer at home.
Time frame: Up to 48 weeks
Incidence of grade 3+ adverse events (AEs)
Incidence, type, and severity of AEs experienced during the study period will be reported. The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For individual adverse events and overall, the frequency and proportion of grade 3+ adverse events and grade 3+ adverse events at least possibly related to cancer treatment delivery will be reported for the entire study treatment period and by location of cancer treatment delivery (i.e., in clinic versus at home).
Time frame: Up to 30 days after last dose of study treatment
Acute care visits, emergency room visits, and hospitalizations
The frequency and proportion of patients who experience an acute care visit, emergency room visit, or hospitalization will be reported for the entire study treatment period and by location of cancer treatment delivery (i.e., during in clinic cancer treatment versus at-home cancer treatment).
Time frame: Up to 48 weeks
Avoidable acute care visits, emergency room visits and hospitalizations
The frequency and proportion of patients who experience an avoidable acute care visit, emergency room visit, or hospitalization while receiving at-home cancer treatment will be reported. Whether an acute care visit, emergency room visit, or hospitalization could have been avoided from changing the location of cancer treatment delivery will be in the opinion of the treating physician.
Time frame: Up to 48 weeks
Secondary
Patient-reported function and global health status/quality of life
Time frame: Up to 48 weeks
Patient-reported symptoms as measured by Patient Reported Outcomes (PRO)-CTCAE
Time frame: Up to 48 weeks
Patient-reported symptoms as measured by Functional Assessment of Cancer Therapy General Population 5 (FACT GP5)
Time frame: Up to 48 weeks.
Patient Satisfaction and Feedback Questionnaire
Time frame: Up to 48 weeks
Patient satisfaction - Was It Worth It Questionnaire
Time frame: Up to 48 weeks
Eligibility criteria
Study locations (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980