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

NCT06470750 | Recruiting

• 5 other identifiers: CaP PCHCW81XWH2210969W81XWH2210968NCI-2024-0479222-004375
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Time to emergency room visit

  Up to 6 months

• Time to hospital visit

  Up to 6 months

Study Arms (2)

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

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational group 1; Observational group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Roxana S. Dronca, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)