Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) with Advanced Prostate Cancer (CaP)
- Conditions
- Advanced Prostate AdenocarcinomaMetastatic Prostate AdenocarcinomaStage III Prostate Cancer AJCC V8Stage IVB Prostate Cancer AJCC V8
- Interventions
- Other: Non-Interventional Study
- Registration Number
- NCT06470750
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This study evaluates the possibility of patient-centered home care as a new model of cancer care to reduce disparities and improve health related quality of life and patient-reported outcomes in Black patients with advanced prostate cancer.
- Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate a highly innovative project evaluating the feasibility of patient-centered home care PCHC as a new model of cancer care to reduce disparities and improve health related QoL (HRQoL) and patient reported-outcomes (PROs) in Black patients with advanced prostate cancer (CaP). (Phase I) II. Establish patient-centeredness by exploring patients' choice relative to the place of CaP treatment for certain aspects of therapy as well as end-of-life care.
III. Establish the acceptance and impact of PCHC on PROs and HRQoL in BM with advanced CaP.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP 1: Participants take part in a focus group or complete questionnaires and may take part in an interview on study.
GROUP 2: Participants complete questionnaires throughout the study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 77
-
GROUP 1 FOCUS GROUPS:
- Individuals identifying as Black and male who are familiar with the landscape of medical care and cancer
GROUP 1 SURVEYS:
- Are 18 years of age or older
- Have histologic evidence of prostate adenocarcinoma
- Are requiring prostate cancer therapy
- Have an understanding of the protocol and its requirements
- Are willing to fill in a questionnaire and participate in a focused interview
- Are able and willing to sign an informed consent
GROUP 1 INTERVIEWS:
- Enrollment in the survey phase of the protocol
GROUP 2:
- Are 18 years of age or older
- Have histologic evidence of prostate adenocarcinoma
- Are requiring active standard hormone-based therapies (degarelix or leuprolide), antibone resorptive agents (zoledronic acid or denosumab), oral anticancer treatments (abiraterone or second-generation androgen receptor blockers) or intravenous chemotherapy (docetaxel)
- Are receiving part of supportive care/symptom management and/or anti-cancer therapy in the home as part of advanced care at home program (ACH)
- Have an understanding of the protocol and its requirements
- Are able and willing to sign an informed consent
-
GROUP 1 FOCUS GROUPS:
- Individuals who do not identify as Black or male or who have had no extensive interaction with the healthcare system
GROUP 1 SURVEYS:
- Do not identify as Black men
- Have not been diagnosed with advanced/metastatic CaP
- Are not requiring active standard anti-cancer therapy
GROUP 1 INTERVIEWS:
- Not enrolled in the survey phase of the protocol
GROUP 2:
- Do not identify as Black men
- Have not been diagnosed with advanced/metastatic CaP
- Are not requiring active standard anti-cancer therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational group 2 Non-Interventional Study Participants complete questionnaires throughout the study. Observational group 1 Non-Interventional Study Participants take part in a focus group or complete questionnaires and may take part in an interview on study.
- Primary Outcome Measures
Name Time Method Feasibility of Patient-centered Home Care (PCHC) Up to 6 months Participants will be asked to fill in a brief questionnaire regarding: patient preference for location of therapy (at the infusion center or in the home); perceived difficulties (isolation, less contact with hospital staff and other patients, feeling less secure with less back-up outside the hospital setting, the possibility of equipment malfunctions and complications in the home setting); and advantages (less travelling to specialized medical facilities, reduced risk of hospital acquired infections or blood clots, the ability to receive treatment in the comfort and security of the home, less disruption to family life, increased feeling of control over treatment and illness). Feasibility will be assessed based on responses to the questionnaire.
- Secondary Outcome Measures
Name Time Method Time to hospital visit Up to 6 months The time to first hospitalization will be recorded.
Time to emergency room visit Up to 6 months Time to first emergency room visit will be recorded.
Trial Locations
- Locations (1)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States