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

NCT02564120 | Completed Results

• 1 other identifier: UNC-10-1483
• Study Type: observational
• Target: 1,556
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Cancer-specific Quality of Life

  Prostate Cancer Symptom Indices (PCSI) - measures treatment-related morbidity and adverse effects and is comprised of 4 functional scales measuring Sexual Dysfunction, Bowel Problems, Urinary Incontinence, and Urinary Obstruction/Irritation. Four parallel distress indices measure distress from symptoms. In each index, patient answers are converted to a score from 0 (no symptom/distress) to 100 (maximum symptoms/distress). A 5-10 point difference in QOL is considered "clinically meaningful."

  4 years

• Overall Quality of Life

  Short Form-12 (SF12) - Measures health-related quality of life. Consists of Likert response formats that assess overall health, mental health, vitality, social functioning, and whether ones health or pain limits their daily physical activities. The SF-12 also contains four categorical questions (yes or no) that assess limitations in functioning due to physical and emotional health. The SF-12 provides the Mental Component Summary score (MCS) and Physical Component Summary score (PCS), calculated using norm-based scoring, with the mean set at 50 and standard deviation 10. A lower score indicates lower QOL.

  4 years

• Prostate Cancer Recurrence

  Percentage of patients who had a recurrence of prostate cancer during 5 years of follow-up.

  From date of completion of treatment (radiation or surgery) until the date of recurrence or date of death from any cause, whichever came first, assessed up to 5 years.

Secondary Outcomes (3)

• Prostate Cancer Anxiety

  4 years

• Decisional Regret

  4 years

• 5-year Mortality

  From date of diagnosis until date of death or end of follow-up up to 5 years

Other Outcomes (2)

• Number of Physician Visits During Follow-up

  4 years

• Number of Diagnostic Tests and Procedures During Follow-up

  4 years

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly-diagnosed, early stage (localized, non-metastatic) prostate cancer patients

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Ronald Chen
• Organization: The University of North Carolina at Chapel Hill

ronald_chen@med.unc.edu

984-974-0400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 30, 2015
• Study Start: January 1, 2011
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 28, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-04

Locations

US (1)