Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Advanced Prostate Cancer (CaP)

Clinicaltrials.gov ID: NCT06470750
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 77

Conditions

Advanced Prostate Adenocarcinoma, Metastatic Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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 Study

    Description:

    Non-interventional study

Observational group 2

Participants complete questionnaires throughout the study.

  • OTHER:

    Non-Interventional Study

    Description:

    Non-interventional study

Outcome Measures

Primary Outcome Measures

Feasibility of Patient-centered Home Care (PCHC)

Time Frame: Up to 6 months

Secondary Outcome Measures

Time to emergency room visit

Time Frame: Up to 6 months

Time to hospital visit

Time Frame: Up to 6 months

Timeline

  • Last Updated
    July 29, 2024
  • Start Date
    June 24, 2024
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    July 30, 2026

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