Feasibility of Patient-Centered Home Care (PCHC) to Reduc... | NCT06470750

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

NCT06470750

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Jan 20, 2026Actual

Enrollment

77Estimated

Phase

Not provided

Conditions

Prostate Adenocarcinoma

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
W81XWH2210969	Other Grant/Funding Number	Department of Defense
W81XWH2210968	Other Grant/Funding Number	Department of Defense
NCI-2024-04792	Registry Identifier	CTRP (Clinical Trial Reporting Program)
22-004375	Other Identifier	Mayo Clinic Institutional Review Board
CaP PCHC	Other Identifier	Mayo Clinic in Florida

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2024Actual

Primary Completion Date

Jul 30, 2026Estimated

Completion Date

Jul 30, 2026Estimated

First Submitted Date

Jun 18, 2024

First Submission Date that Met QC Criteria

Jun 18, 2024

First Posted Date

Jun 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2026

Last Update Posted Date

Jan 20, 2026Actual

Name	Class
Congressionally Directed Medical Research Programs	FED

Description Module

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.

Label	Type	Description	Intervention Names
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
Observational group 2		Participants complete questionnaires throughout the study.	Other: Non-Interventional Study

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational group 1 Observational group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of Patient-centered Home Care (PCHC)	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.	Up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Time to emergency room visit	Time to first emergency room visit will be recorded.	Up to 6 months
Time to hospital visit	The time to first hospitalization will be recorded.

Other Outcomes

Not provided

Eligibility Module

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:
- 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals identifying as Black and male who are familiar with the landscape of medical care and cancer, as well as individuals identifying as an African American/Black man with prostate adenocarcinoma requiring prostate cancer therapy and individuals identifying as an African American/Black man with prostate adenocarcinoma requiring active standard hormone-based therapies, antibone resorptive agents, oral anticancer treatments, or intravenous chemotherapy and receiving part of supportive care/symptom management and/or anti-cancer therapy in the home as part of the Advanced Care at Home Program

Sampling Method

Non-Probability Sample