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.
Age ≥ 18 years
Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g., NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines
Black or African American male patients with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer who are currently receiving or planning to start treatment with one or more of the eligible regimens. Patients may be on any combination of these regimens, provided that at least one is administered by a home health nurse [co-administration with second generation antiandrogens, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted]
Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Ongoing or active infection
Single group
Cancer Therapeutic Procedure
DrugGiven standard of care cancer treatment in clinic
Cancer Therapeutic Procedure
DrugGiven standard of care cancer treatment in home
Health Care Delivery
Other interventionReceive in home cancer treatment with CCBW
Questionnaire Administration
Other interventionAncillary studies
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.
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.
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).
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).
Patient-reported function and global health status/quality of life
Will be measured by the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Functioning 17 (QLQ-F17), scored following its published scoring algorithm. Higher scores indicate better quality of life
Patient-reported symptoms as measured by Patient Reported Outcomes (PRO)-CTCAE
PRO-CTCAE uses a 0-4 scoring system for most items, with 0 representing the absence of a symptom or no impact, and 4 representing the highest severity or impact. Some items, specifically those assessing presence, use a 0/1 (absent/present) scale. The frequency and proportion of patients with a maximum baseline-adjusted composite score ≥ 3 during the study treatment period and by location of cancer treatment delivery will be reported.
Patient-reported symptoms as measured by Functional Assessment of Cancer Therapy General Population 5 (FACT GP5)
The FACT GP5 consists of a single question, "I am bothered by side effects of treatment," rated on a scale of 0-4 where 0=not at all and 4=very much.
Patient Satisfaction and Feedback Questionnaire
Patient satisfaction will be measured by the Patient Satisfaction and Feedback Questionnaire (specific to this study). The questionnaire consists of 30 questions evaluating different aspects of care, including level of care (excellent, very good, good, faire poor), preference for location of care (at home vs in clinic), comparison of care at home vs in clinic (strongly agree, disagree, neither agree nor disagree, agree, strongly agree), communication received from care team (0-10 where 0=worst communication possible and 10=best communication possible), transition to care at home and use of at-home equipment (very easy, easy, neither, difficult, very difficult). Patient responses will be summarized descriptively.
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Mayo Clinic
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
