Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors

NCT02957357 | Completed Results

• 1 other identifier: AFT-30
• Study Type: observational
• Target: 11,314
• Locations: 0 countries
• Sites: N/A

Brief Summary

Through this study, the investigators seek to identify the benefits (improved survival) and harms (more procedures, more treatment, side effects, and quality-of-life impact) from different surveillance frequencies-every three vs. six vs. 12 months. Using the National Cancer Database and quality-of-life data from a large group of prostate cancer survivors, the investigators aim to compare survival, procedures/tests, treatments, and side effects in prostate cancer survivors who are followed with alternative surveillance frequencies and compare quality-of-life outcomes. The overall goal of the study is to provide high-quality data that will allow development of a personalized, risk-based tailored approach to post-treatment surveillance for prostate cancer.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Time to death or date of last follow-up after primary treatment with surgery or radiation.

  From completion of primary treatment with surgery or radiation to the earliest occurrence of death, loss to follow-up, or the end of the study period.

• Prostate Cancer Anxiety

  Prostate cancer anxiety was measured annually (starting 12 months after participant enrollment) using the validated Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The instrument contains 18 questions across 3 subscales assessing anxiety related to prostate cancer (11 items), PSA testing (3 items), and fear of recurrence (4 items). Each item was scored on a Likert-type scale (1 to 4), with a higher score indicating greater anxiety. The subscale means represent the average scores across the items in that sub-scale. The mean Total MAX-PC scores represent the average scores across the 3 subscales (anxiety related to prostate cancer; anxiety related to PSA testing; and anxiety related to prostate cancer recurrence).

  12 to 60 months after participant enrollment

Secondary Outcomes (4)

• Time to Prostate Cancer Recurrence

  Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period

• Treatment for Prostate Cancer Recurrence

  Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period

• Prostate Cancer-Specific Health-Related Quality of Life

  12 to 60 months after participant enrollment

• Global Health-Related Quality of Life

  12 to 60 months after participant enrollment

Study Arms (2)

National Cancer Data Base

Patients within the National Cancer Database with newly diagnosed prostate cancer between 2004 and 2010. Participating institutions each provided a random of sample of 10 patients to be included in the final cohort.

NC ProCESS

The North Carolina Prostate cancer Comparative Effectiveness \& Survivorship Study (NC ProCESS) is a prospective population-based cohort of \>1,000 patients with newly diagnosed prostate cancer, enrolled from January 2011 through June 2013.

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 14,000 prostate cancer patients in the National Cancer Data Base (nationwide cancer registry) will be analyzed. The investigators will analyze data from the National Cancer Data Base (NCDB), a cancer registry which is maintained by the American College of Surgeons Commission on Cancer (CoC). Cancer registry staff review hospital and provider records to collect necessary data for the cancer registry so data are available for analysis for this project. There are \>1400 CoC-hospitals; 10 patients will be sampled at each hospital thus 14,000 patients will be available for analysis. The NC ProCESS cohort consists of newly-diagnosed, early stage (localized, non-metastatic) prostate cancer patients.

You may qualify if:

• Patient data part of the NCDB
• Diagnosed with prostate cancer in 2004-2005.
• Treated for prostate cancer with surgery (prostatectomy) or radiation therapy

You may not 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.
• Initiation of treatment for prostate cancer prior to completion of baseline interview.
• Cognitive impairment.
• Hearing problems.
• Inability to speak or understand English.

Sponsors & Collaborators

• Alliance Foundation Trials, LLC.: lead
• Patient-Centered Outcomes Research Institute: collaborator

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

Study Officials

• Ronald Chen, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: February 1, 2016
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: October 20, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share