Clinical trial NCT04293406: pCHIP: Prostate Cancer Health Impact Program
Official title: WCM Catchment Prostate Cancer Health Impact Program (pCHIP)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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).

Eligibility 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

Primary outcomes:
measure: Development of Evidence-Based Decision Navigation Intervention through Semi-Structured Interviews for AA and H/L men diagnosed with prostate cancer
timeFrame: 1 Day
Secondary outcomes:
measure: 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
timeFrame: Up to 6 months
measure: 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
timeFrame: Up to 6 months
measure: 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
timeFrame: Up to 6 months
measure: 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
timeFrame: Up to 6 Months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York-Presbyterian Brooklyn Methodist
state: New York
city: Fresh Meadows
country: United States
facility: New York-Presbyterian Queens
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Joseph Osborne, MD/Ph.D
role: PRINCIPAL_INVESTIGATOR
References: