North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)

NCT ID: NCT02564120

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1556 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2018-12-31

Brief Summary

NC ProCESS is a cohort of patients from diverse backgrounds diagnosed with early prostate cancer, who were enrolled from January 2011-June 2013. These patients were recruited throughout North Carolina, and also in partnership with institutions across the country. Patients enrolled before they start treatment, and are then followed prospectively through treatment and then afterwards. This observational study collects information on quality of life, cancer control, and health care received inclusive of treatment and management of subsequent effects including complications and recurrence. The objective of this study is to examine comparative outcomes among different modern prostate cancer treatment options in this cohort of patients.

Detailed Description

Localized prostate cancer treatment options is consistently a "highest priority" comparative effectiveness research (CER) topic according to the Institute of Medicine, Agency for Healthcare Research and Quality (AHRQ), and other summary reports. Patients urgently need information on the comparative outcomes of modern treatment options to guide decision-making for this disease that causes significant burden based on its high prevalence, mortality and treatment effects on quality of life. The status quo as it pertains to prostate cancer is significant overtreatment causing potential patient harm, rapid diffusion of new/expensive technologies without proven benefit and patients lacking high quality research evidence to balance direct-to-consumer advertising and guide individualized decision-making.

NC ProCESS is a population-based cohort designed specifically to address well-described knowledge gaps. It was designed in close collaboration with the unique AHRQ consortium stakeholder group, which included representatives from patients, clinicians and policymakers. Stakeholders helped define study design to emphasize "real-world" patients and select patient-centered and relevant outcomes, and have been involved throughout assembly of this patient cohort. The diverse cohort is well-represented by "hard to reach" patients; enrollment before treatment avoids biases with participation and recall. As clinical trials are not feasible to address the central questions in prostate cancer CER, this prospective study will yield the highest level of evidence to inform patients and other stakeholders. With an assembled cohort, this study is necessary to examine comparative outcomes.

Conditions

Cancer of Prostate; Cancer of the Prostate; Prostate Cancer; Prostatic Cancer

Study Design

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

Eligibility Criteria

Inclusion Criteria

• Newly-diagnosed, histologically-proven, localized prostate adenocarcinoma.
• Completion of baseline interview prior to initiating therapy.
• Patient ability to complete study interview: no cognitive impairment, language or hearing problems.
• Not diagnosed with prostate cancer through transurethral resection of the prostate (TURP).
• Age 35-80.
• English speaking.
• Has telephone.

Exclusion Criteria

• Initiation of treatment for prostate cancer prior to completion of baseline interview.
• Cognitive impairment.
• Hearing problems.
• Inability to speak or understand English.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UNC-10-1483

Identifier Type: -

Identifier Source: org_study_id