pCHIP: Prostate Cancer Health Impact Program

Prostate Cancer Clinical Trial

Official title:

WCM Catchment Prostate Cancer Health Impact Program (pCHIP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04293406
• Other study ID #: 19-10021003
• Status: Recruiting
• Start date: February 10, 2021
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Weill Medical College of Cornell University
• Contact: Joseph Osborne, MD/Ph.D
• Phone: 212-746-6797
• Email: jro7001[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	New York-Presbyterian Brooklyn Methodist	Brooklyn	New York
United States	New York-Presbyterian Queens	Fresh Meadows	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	The Decisional Self-Efficacy scale will be used to assess confidence to participate in decision making at a level personally desired.; The 11 items require participants to reflect on confident levels about various aspects of the decision-making process. Responses are measured on a Likert scale that range from 0, not at all confident, to 4, very confident. Scores range from 0 (low self-efficacy) to 100 (high self-efficacy)	Up to 6 months
Secondary	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	Preference for control in the decision-making process will be assessed with the Control Preference Scale.; Individuals are asked, "Who should make medical decisions?" Response options included: "I make the final decision on my own;"; "I make the decision after seriously considering my doctor's opinion;"; "My doctor and I share responsibility for the decision;"; "I prefer that the doctor make the decision after seriously considering my opinion;"; "I prefer that the doctor make the decision."; Responses will be collapsed and categorized into 3 categories: Active decision-making styles (options a and b) Collaborative styles (option c) Passive styles (options d and e)	Up to 6 months
Secondary	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	The comprehensive Health Information National Trends Survey (HINTS) will be used to assess cancer education and healthcare access, history, and attitudes with a focus on prostate cancer prostate cancer and colorectal cancer (CRC) screening behaviors, knowledge of cancer trials, and use of internet/mHealth technologies assessment.; HINTS data can be used to inform the design, content, and evaluation of cancer control initiatives by revealing where knowledge of and/or behavioral engagement in cancer control strategies are low; by highlighting the media used most often to obtain cancer control information; and by providing national-level trends in behavioral factors related to cancer control. Additionally, subgroup-specific analyses of HINTS data can be used to inform tailored cancer control planning efforts (e.g., by gender, race/ethnicity, socioeconomic status, cancer history).	Up to 6 months
Secondary	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	The Decision Regret Scale measures "distress or remorse after a (health care) decision." In a short introductory statement, respondents are asked to reflect on a specific past decision, and then asked to indicate the extent to which they agree or disagree with the statements in the regret scale by indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. Regret is measured at a point in time when the respondent can reflect on the effects on the decision.; Items 2 and 4 should be reversed coded so that, for each item, a higher number will indicate more regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.	Up to 6 Months