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

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Mayo Clinic

Status

Enrolling

Conditions

Prostate Adenocarcinoma

Treatments

Other: Non-Interventional Study

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT06470750
NCI-2024-04792 (Registry Identifier)
CaP PCHC (Other Identifier)
W81XWH2210969 (Other Grant/Funding Number)
W81XWH2210968 (Other Grant/Funding Number)
22-004375 (Other Identifier)

Details and patient eligibility

About

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 prostate cancer.

Full 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.

Enrollment

77 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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, have required, or will require prostate cancer treatment
    • 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
    • Are Black men or other discounted patients (older adults, individuals residing in rural or remote areas, and those facing transportation challenges)
    • 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 Cancer Care Beyond Walls (CCBW)
    • Have an understanding of the protocol and its requirements
    • Are able and willing to sign 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 prostate cancer
  • GROUP 1 INTERVIEWS:

    • Not enrolled in the survey phase of the protocol
  • GROUP 2:

    • Do not identify as Black men or other discounted patients (older adults, individuals residing in rural or remote areas, and those facing transportation challenges)
    • Have not been diagnosed with histologic evidence of prostate adenocarcinoma
    • Are not requiring active standard anti-cancer therapy

Trial design

77 participants in 2 patient groups

Observational group 1
Description:
Participants take part in a focus group or complete questionnaires and may take part in an interview on study.
Treatment:
Other: Non-Interventional Study
Observational group 2
Description:
Participants complete questionnaires throughout the study.
Treatment:
Other: Non-Interventional Study

Trial contacts and locations

1

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Central trial contact

Clinical Trials Referral Office

Data sourced from clinicaltrials.gov

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