Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06470750

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Roxana S. Dronca, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Feasibility of Patient-centered Home Care (PCHC)

    Time frame: 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 outcomes

  1. Time to emergency room visit

    Time frame: Up to 6 months

    Time to first emergency room visit will be recorded.

  2. Time to hospital visit

    Time frame: Up to 6 months

    The time to first hospitalization will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.