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Completed

NCT Number: NCT02564120

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

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.

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Key information

Conditions

Cancer Of Prostate Cancer of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

35 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cancer-specific Quality of Life

    Time frame: 4 years

    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."

  2. Overall Quality of Life

    Time frame: 4 years

    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.

  3. Prostate Cancer Recurrence

    Time frame: 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.

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

Secondary outcomes

  1. Prostate Cancer Anxiety

    Time frame: 4 years

    Prostate cancer anxiety was measured by the validated Memorial Anxiety Scale for Prostate Cancer (MAX-PC), with 18 questions assessing anxiety related to prostate cancer (11 items, total score 0 to 33), PSA testing (3 items, total score 0 to 9), and fear of recurrence (4 items, total score 0 to 12). The subscale for prostate cancer anxiety asks the patient to report how frequently comments about prostate cancer were true for them during the past week (not at all, rarely, sometimes, or often). The subscale for PSA testing anxiety asks the patient to indicate how frequently situations have ever been true for them. The subscale for anxiety related to prostate cancer recurrence asks the patient to indicate how much they agree or disagree with statements about their own health during the past week. A higher score in each subscale indicates more anxiety.

  2. Decisional Regret

    Time frame: 4 years

    Decisional regret was measured by a validated scale for prostate cancer. The five items of the decisional regret scale assess (on a Likert scale) a patient's feeling that he chose the wrong treatment, a wish to change the decision, or doubt about treatment value.

    Answers are converted to a score from 0 (no regret) to 100 (maximum regret). Decisional regret provides an assessment of the overall decisional and treatment experience from a patient perspective.

  3. 5-year Mortality

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

    Percentage of patients who died within 5 years of follow-up.

Other outcomes

  1. Number of Physician Visits During Follow-up

    Time frame: 4 years

    Number of physician and specialist visits during treatment, subsequent monitoring of recurrence and management of prostate cancer treatment-related morbidity. Assessed through analysis of healthcare claims linked to cohort data.

  2. Number of Diagnostic Tests and Procedures During Follow-up

    Time frame: 4 years

    Number of diagnostic tests and procedures including biopsies, radiographic scans, laboratory tests, and procedures to assess cancer progression (active surveillance) or recurrence and work-up for treatment-related morbidity. Assessed through analysis of healthcare claims linked to cohort data.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2015
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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