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Clinical Trials/NCT06470750
NCT06470750
Recruiting
Not Applicable

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

Mayo Clinic1 site in 1 country77 target enrollmentJuly 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Mayo Clinic
Enrollment
77
Locations
1
Primary Endpoint
Feasibility of Patient-centered Home Care (PCHC)
Status
Recruiting
Last Updated
3 months ago

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
July 25, 2024
End Date
July 30, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

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, 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:

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
  • 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

Outcomes

Primary Outcomes

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

  • Time to hospital visit(Up to 6 months)
  • Time to emergency room visit(Up to 6 months)

Study Sites (1)

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