Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Advanced Prostate Cancer (CaP)
Conditions
Advanced Prostate Adenocarcinoma, Metastatic Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8Summary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Clinical Trials Referral Office
- 855-776-0015
- [email protected]
Principal Investigator
- Roxana S. Dronca, M.D.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 Plan
Observational group 1
Participants take part in a focus group or complete questionnaires and may take part in an interview on study.
OTHER:
Non-Interventional StudyDescription:
Non-interventional study
Observational group 2
Participants complete questionnaires throughout the study.
OTHER:
Non-Interventional StudyDescription:
Non-interventional study
Outcome Measures
Primary Outcome Measures
Feasibility of Patient-centered Home Care (PCHC)
Secondary Outcome Measures
Time to emergency room visit
Time to hospital visit
Timeline
Last Updated
July 29, 2024Start Date
June 24, 2024Today
February 5, 2025Completion Date ( Estimated )
July 30, 2026
Sponsors of this trial
Lead Sponsor
Mayo Clinic