pCHIP: Prostate Cancer Health Impact Program

Weill Cornell Medicine (WCM)

Status: Terminated

Conditions: Prostate Cancer

Treatments: Other: Decision Navigation Intervention (DNI)

Study type: Observational

Funder types: Other

Identifiers

NCT04293406

19-10021003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 82 patients

Sex: Male

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Established Prostate Cancer Group:

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.

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:

Inclusion Criteria:

• 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:

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

Trial design

82 participants in 2 patient groups

Established Prostate Cancer Group

Description:

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

Description:

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).

Treatment:

Other: Decision Navigation Intervention (DNI)