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

NCT ID: NCT06470750

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-25

Study Completion Date

2026-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational group 1

Participants take part in a focus group or complete questionnaires and may take part in an interview on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Observational group 2

Participants complete questionnaires throughout the study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Congressionally Directed Medical Research Programs

FED

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roxana S. Dronca, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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W81XWH2210969

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W81XWH2210968

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCI-2024-04792

Identifier Type: REGISTRY

Identifier Source: secondary_id

22-004375

Identifier Type: OTHER

Identifier Source: secondary_id

CaP PCHC

Identifier Type: OTHER

Identifier Source: secondary_id

CaP PCHC

Identifier Type: -

Identifier Source: org_study_id

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