pCHIP: Prostate Cancer Health Impact Program

NCT04293406 | Terminated

• 1 other identifier: 19-10021003
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

This project focuses on African American (AA) men and Hispanic/Latino (H/L) men with prostate cancer (PCa) in Brooklyn/Queens catchment. Evidence from randomized clinical trials support the efficacy of decision navigation intervention, with navigated patients showing greater confidence in their decisions about cancer treatment and less regret. The investigators will develop and test the acceptability and feasibility of a decision navigation intervention for AA or H/L men with prostate cancer. The primary aim for this study is to adapt and tailor an evidence based decision navigation intervention for AA and H/L men newly diagnosed with prostate cancer (PCa). The investigators hypothesize that men in the decision navigation intervention arm will report higher levels of decision self-efficacy, less decisional conflict, and regret about their treatment decisions compared to men engaged in standard of care.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Development of Evidence-Based Decision Navigation Intervention through Semi-Structured Interviews for AA and H/L men diagnosed with prostate cancer

  By conducting semi-structured interview, the investigators will adapt and tailor an evidence-based decision navigation intervention (DNI) for AA and H/L men diagnosed with prostate cancer. Semi-structured interviews consist of participant information and free-response questions. Participant information such as, contact information, health information, prostate cancer risk perception, basic demographic and chart abstractions will be recorded.

  1 Day

Secondary Outcomes (4)

• Decisional Self-Efficacy as measured by the Decisional Self-Efficacy Scale between Decision Navigation Intervention versus Standard of Care for AA and H/L men newly diagnosed with prostate cancer

  Up to 6 months

• Preference for Control in the Decision-making as measured by the Control Preference Scale between Decision Navigation Intervention versus Standard of Care for AA and H/L men newly diagnosed with prostate cancer

  Up to 6 months

• Health Information as measured by the Health Information National Trends Survey (HINTS) between Decision Navigation Intervention versus Standard of Care for AA and H/L men newly diagnosed with prostate cancer

  Up to 6 months

• Regret as Measured by the Decision Regret Scale between Decision Navigation Intervention versus Standard of Care for AA and H/L men newly diagnosed with prostate cancer

  Up to 6 Months

Study Arms (2)

Established Prostate Cancer Group

Established Prostate Cancer Group will consist of a qualitative study of 12 semi-structured interviews with self-identified AA patient undergoing prostate treatment (stages I-III) (N-12 patients) and 12 semi-structured interviews with H/L patient undergoing prostate treatment (stages I-III) (N=12 patients) at NYPH Queens and NYPH-BM. Interview content will focus on psycho-social and socio-cultural factors associated with prostate cancer decision making, social support, and physician-patient communication.

At Risk of Prostate Cancer Group

At Risk of Prostate Cancer Group will recruit 58 self-identified AA or H/L men at risk of prostate cancer (stages I-III) receiving care at NYPH-Queens and NYPHQ (29 at each hospital) to participate in the evaluation of the tailored DNI intervention. Men who consent to participate in the study will complete a baseline survey. After biopsy appointment, participants with a negative Prostate Cancer biopsy will receive a study closure phone call, ending study participation. Participants with positive Prostate Cancer biopsy will proceed with study procedures and be randomly assigned to decision navigation intervention (DNI) or standard of care (SOC). Participants with a positive Prostate Cancer biopsy will be followed for 6 months and complete assessments at 2 weeks, 1 month, and 6 months (close of the study).

Other: Decision Navigation Intervention (DNI)

Interventions

Decision Navigation Intervention (DNI) OTHER

This study will develop and test the acceptability and feasibility of a decision navigation intervention (DNI) for AA or H/L men with prostate cancer through consideration of the role of partners and family members in the decision-making process. In the decision navigation intervention (DNI), participants will meet with the navigator in person or via phone, prior to their specialist treatment consultation. At the end of the DNI visit, participants will receive a personalized list of prioritized questions. At the end of the decision navigation appointment, all navigated patients will complete a five-item navigation rating scale evaluating the intervention and its impact on their preparation for the consultation visit.

At Risk of Prostate Cancer Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Established Prostate Cancer Group will consist of a qualitative study of 12 semi-structured interviews with self-identified AA patient undergoing prostate treatment (stages I-III) (N=12 patients) and 12 semi-structured interviews with H/L patient undergoing prostate treatment (stages I-III) (N=12 patients) At Risk of Prostate Cancer Group will recruit 58 self-identified AA or H/L men at risk of Prostate Cancer (stages I-III) receiving care at NYP-Brooklyn Methodist and NYP-Queens (29 at each hospital)

You may qualify if:

• Participant must be designated male at birth
• Self-identified AA or H/L
• Be 18 years of age or older
• Fluent in English or Spanish
• Able to provide informed consent.

You may not qualify if:

• Patients or shared decision makers with cognitive or sensory impairment which impede their ability to provide informed consent as determined by consenting individual or documented in the medical record.
• At Risk of Prostate Cancer Group:
• Participant must be designated male at birth
• Self-identified AA or H/L
• Be 18 years of age or older
• Have stage I-III PCa, not yet begun cancer treatment
• Have no evidence of progressive disease or second primary cancer
• Men who have already begun cancer treatment
• Have evidence of progressive disease
• Second primary cancer

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (2)

New York-Presbyterian Brooklyn Methodist

Brooklyn, New York, 11217, United States

Location

New York-Presbyterian Queens

Fresh Meadows, New York, 11366, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Joseph Osborne, MD/Ph.D

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: February 10, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)