pCHIP: Prostate Cancer Health Impact Program

NCT ID: NCT04293406

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2024-04-01

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.

Detailed Description

Objectives This study will develop and test the acceptability and feasibility of a decision navigation intervention (DNI) for AA or H/L men with PCa through consideration of the role of partners and family members in the decision-making process.

Hypotheses / Research Questions Among AA or H/L men diagnosed with early stage PCa, the primary aims of this study are to:

Aim 1:

Adapt and tailor an evidence-based decision navigation intervention (DNI) for AA and H/L men diagnosed with prostate cancer. The investigators hypothesize that key concepts around information sharing and counseling, health behavior coordination, and emotional social support will be elicited

Aim 2:

Evaluate the feasibility, acceptability, and preliminary efficacy of the tailored DNI among AA and H/L men newly diagnosed with prostate. First, the investigators hypothesize that feasibility and acceptability benchmarks will be met. Second, the investigators hypothesize that men in the DNI arm will report higher levels of decision self-efficacy, less decisional conflict, and regret about their treatment decisions at 6 months, compared to men engaged in standard-of-care (SOC). Third, the investigators hypothesize (exploratory) that men in the DNI arm will engage more in discussions about appropriate clinical trials, resulting in more navigated men considering clinical trial enrollment, compared to men receiving SOC.

Overall Design

This study will be conducted in two Groups:

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 NYPHQueens and NYPH-BM. Interview content will focus on psychosocial and sociocultural factors associated with PCa 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 DNI or 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).

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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).

Decision Navigation Intervention (DNI)

Intervention Type: 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.

Interventions

Decision Navigation Intervention (DNI)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

Exclusion Criteria

• 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:

• Men who have already begun cancer treatment
• Have evidence of progressive disease
• Second primary cancer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Osborne, MD/Ph.D

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

New York-Presbyterian Brooklyn Methodist

Brooklyn, New York, United States

New York-Presbyterian Queens

Fresh Meadows, New York, United States

Countries

United States

Other Identifiers

19-10021003

Identifier Type: -

Identifier Source: org_study_id