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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate Cancer Anxiety | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Physician Visits During Follow-up | 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. | 4 years |
| Number of Diagnostic Tests and Procedures During Follow-up |
Inclusion Criteria:
Exclusion Criteria:
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Newly-diagnosed, early stage (localized, non-metastatic) prostate cancer patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NC ProCESS Cohort | NC ProCESS is a cohort of patients 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 started treatment, and were then followed prospectively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The analytic cohort comprised 1413 men who completed baseline survey information and either underwent active surveillance (n=390, 27.6%) or received treatment with SBRT (n=104, 7.4%), radical prostatectomy (n=547, 38.7%), conventional fractionation external beam radiation therapy (EBRT; n=247, 17.5%), or brachytherapy (n=125, 8.8%).
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Surveillance | Men placed on active surveillance (i.e., did not receive immediate treatment) |
| BG001 | SBRT | Men who received stereotactic body radiation therapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy. | Posted | Mean | 95% Confidence Interval | score on a scale | 4 years |
|
5 years
Serious and other (not including serious) adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NC ProCESS Cohort | NC ProCESS cohort is a population-based, prospective prostate cancer patient cohort. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronald Chen | The University of North Carolina at Chapel Hill | 984-974-0400 | ronald_chen@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2019 | Sep 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 4 years |
| Decisional Regret | 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. | 4 years |
| 5-year Mortality | Percentage of patients who died within 5 years of follow-up. | From date of diagnosis until date of death or end of follow-up up to 5 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. |
| 4 years |
| Other medical condition |
|
| BG002 | Radical Prostatectomy | Men treated with radical prostatectomy (i.e., surgery) |
| BG003 | EBRT | Men treated with external beam radiation therapy |
| BG004 | Brachytherapy | Men treated with brachytherapy |
| BG005 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan. |
| OG001 | Stereotactic Body Radiation Therapy | Patients who received initial treatment with stereotactic body radiation therapy (SBRT). |
| OG002 | Radical Prostatectomy | Patients who received initial treatment with radical prostatectomy. |
| OG003 | External Body Radiation Therapy | Patients who received initial treatment with external body radiation therapy (EBRT). |
| OG004 | Brachytherapy | Patients who received initial treatment with brachytherapy. |
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| Primary | 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. | We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy. | Posted | Mean | 95% Confidence Interval | score on a scale | 4 years |
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| Primary | Prostate Cancer Recurrence | Percentage of patients who had a recurrence of prostate cancer during 5 years of follow-up. | We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Prostate Cancer Anxiety | 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. | We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy. | Posted | Mean | 95% Confidence Interval | score on a scale | 4 years |
|
|
|
| Secondary | Decisional Regret | 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. | We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy. | Posted | Number | 95% Confidence Interval | percentage of participants | 4 years |
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| Secondary | 5-year Mortality | Percentage of patients who died within 5 years of follow-up. | We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of diagnosis until date of death or end of follow-up up to 5 years |
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| Other Pre-specified | Number of Physician Visits During Follow-up | 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. | We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy. | Posted | Mean | Standard Deviation | visits | 4 years |
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| Other Pre-specified | Number of Diagnostic Tests and Procedures During Follow-up | 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. | We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy. | Posted | Mean | Standard Deviation | tests or procedures | 4 years |
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| 58 |
| 1,110 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Physical Health - 3-months |
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| Physical Health - 12-months |
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| Physical Health - 24-months |
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| Physical Health - 36-months |
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| Physical Health - 48-months |
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| Mental Health - Baseline |
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| Mental Health - 3-months |
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| Mental Health - 12-months |
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| Mental Health - 24-months |
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| Mental Health - 36-months |
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| Mental Health - 48-months |
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| Prostate cancer anxiety - 24-months |
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| Prostate cancer anxiety - 36-months |
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| Prostate cancer anxiety - 48-months |
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| Recurrence anxiety - 12-months |
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| Recurrence anxiety - 24-months |
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| Recurrence anxiety - 36-months |
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| Recurrence anxiety - 48-months |
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| PSA test anxiety - 12-months |
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| PSA test anxiety - 24-months |
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| PSA test anxiety - 36-months |
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| PSA test anxiety - 48-months |
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| 24-months |
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| 36-months |
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| 48-months |
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| Total physician visits |
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| General practitioner visits |
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| Urology/Oncology visits |
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| Other specialists visits |
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| Other tests and procedures |
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| Total tests and procedures |
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