Smart Prostate Specific Antigen (PSA) Screening Study

Prostate Cancer Clinical Trial

Official title:

Smart PSA Screening Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04782713
• Other study ID #: 2020-1251
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: November 2024

Study information

• Verified date: August 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This intervention includes the introduction of the Prostate Cancer Working Group (PCWG )Smart PSA Screening Guidelines and implementation of patient navigation/ care coordination for men with elevated PSA (>4.0 ng/mL).

The guidelines include:

1. What age to start?

2. How often to repeat screening?

3. What age to stop?

4. What PSA threshold should trigger a biopsy referral?

Description:

Primary care providers (PCP) hold the key to implementing effective early detection of Prostate Cancer (PCa), but uncertainty about how to use PSA for screening without causing undue overtreatment of indolent cancer, has greatly inhibited implementation, even in high-risk communities. This is a single-arm intervention study to test implementation of the Smart PSA strategy plus system-level patient navigation/ care coordination in the Mile Square Health Center(MSHC), in order to: a) identify barriers and facilitators to inform implementation of care, b) evaluate the impact on provider confidence regarding prostate cancer screening, and, c) measure its effect on observed PSA levels, biopsy referral rates, and biopsy outcomes.

100 PCPs employed by MSHC who provide care for male adults will be asked to participate in surveys at baseline, (prior to an in-service training) and at 3,6, 9 and 12 months. The surveys will use 5-point Likert scales to assess the respondent's self-report of their knowledge regarding PSA screening, attitudes, behavior; and confidence in presenting the issue, discussing it with patients, interpreting results and making recommendations based on them; and to elicit comments on how to improve implementation.

Historical data of 4500 patients covering a one year period prior to the intervention will be used to measure the impact of the intervention on measurable outcomes

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for PCP:

• PCP employed by MSHC who provides care for male adult patients

Exclusion Criteria for PCP:

• Not a PCP employed by MSHC who provides care for male adult patients

Inclusion Criteria for Patient navigator/care coordinator:

• Male

• Age 40-75

• Clinic visit at a MSHC site

• Elevated PSA (>4.0 ng/ml)

Exclusion Criteria for Patient navigator/care coordinator:

• Not meeting the inclusion criteria

Inclusion criteria for chart and database review:

• Male

• Age 40-75

• Clinic visit at a MSHC site from date of study start through 12 months (comparison of 12-month intervention period to periods before and after intervention implementation)

Exclusion Criteria for chart and database review:

• Not meeting the inclusion criteria

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• PSA

Intervention

Other:
• Completing surveys
Completing surveys at baseline, 3, 6, 9, and 12 months

Locations

Country	Name	City	State
United States	Mile Square Health Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of PSA tests ordered per number of clinical encounters 12 months prior to the intervention	Review Pathology Laboratory Services, Ambulatory Services Administration, UI Health for PSA orders	Monthly for 12 months prior to intervention
Primary	Number of PSA tests ordered per number of clinical encounters during the intervention	Review Pathology Laboratory Services, Ambulatory Services Administration, UI Health for PSA orders	Monthly for 12 months during intervention
Primary	Number of PSA levels categorized as <4.0, 4.0-10.0 and >10.0 12 month prior to the intervention	Review Pathology Laboratory Services, UI Health PSA results	Monthly for 12 months prior to intervention
Primary	PSA levels categorized as <4.0, 4.0-10.0 and >10.0 during the intervention	Review Pathology Laboratory Services, UI Health PSA results	Monthly for 12 months during intervention
Primary	Number of Urology referrals 12 months prior to the intervention	Review electronic medical records for urology referrals	12 months prior to intervention
Primary	Number of Urology referrals during the intervention	Review electronic medical records for urology referrals	12 months after intervention
Primary	Number of prostate biopsies performed using the risk levels of the National Comprehensive Cancer Network (NCCN) of very low, Favorable intermittent, Unfavorable intermittent, High, very high 12 months prior to the intervention	Review electronic medical records for biopsies performed	12 months prior to the intervention
Primary	Number of prostate biopsies performed using the risk levels of the National Comprehensive Cancer Network (NCCN) of very low, Favorable intermittent, Unfavorable intermittent, High, very high during the intervention	Review electronic medical records for biopsies performed	12 months after the intervention
Primary	Number of prostate biopsy complications 12 months prior to the intervention	Review electronic medical records and pharmacy database for biopsy complications using NCI Common Toxicity Criteria to rate complications from mild to life-threatening	12 months prior to intervention
Primary	Number of prostate biopsy complications during the intervention	Review electronic medical records and pharmacy database for biopsy complications using NCI Common Toxicity Criteria to rate complications from mild to life-threatening	12 months after intervention
Primary	Benefit and harm analysis 12 months prior to the intervention	Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient diagnosed per NCCN: Very Low, Low, Favorable intermediate, Unfavorable Intermediate, High, Very High. Subgroup analyses by age, race and previous screening history will be performed. Attention will be focused on relative changes in the number of clinically significant but treatable cases to the number of clinically insignificant cases. Clinically significant but treatable cases will be defined as NCCN Intermediate (thus all localized Gleason 7); clinically insignificant cases will be defined as NCCN Very Low (PSA<10, Gleason grade = 6, T1c, < 3 positive cores, no core > 50% cancer, PSA density < 0.15	12 months prior to intervention
Primary	Benefit and harm analysis 12 months prior to the intervention	Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on age and race	12 months prior to intervention
Primary	Benefit and harm analysis 12 months prior to the intervention	Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on previous screening history	12 months prior to intervention
Primary	Benefit and harm analysis 12 months prior to the intervention	Compare the number of clinically significant but treatable cases to the number of clinically insignificant cases. Clinically significant but treatable cases will be defined as NCCN Intermediate with localized Gleason grade 7, clinically insignificant cases will be defined as NCCN Very Low PSA<10, Gleason grade = 6, T1c, < 3 positive cores, no core > 50% cancer, PSA density < 0.15	12 months prior to intervention
Primary	Benefit and harm analysis during the intervention	Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient diagnosed per NCCN: Very Low, Low, Favorable intermediate, Unfavorable Intermediate, High, Very High.	12 months after intervention
Primary	Benefit and harm analysis during the intervention	Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on age and race	12 months after intervention
Primary	Benefit and harm analysis during the intervention	Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on previous screening history	12 months after intervention
Primary	Benefit and harm analysis during the intervention	Compare the number of clinically significant but treatable cases to the number of clinically insignificant cases. Clinically significant but treatable cases will be defined as NCCN Intermediate with localized Gleason grade 7, clinically insignificant cases will be defined as NCCN Very Low PSA<10, Gleason grade = 6, T1c, < 3 positive cores, no core > 50% cancer, PSA density < 0.15	12 months after intervention
Primary	Number of PCPs that have confidence in discussing prostate issues 12 months prior to the intervention	Analyses of graphing mean trajectories in response to repeat surveys among PCPs at baseline, 3, 6, 9 and 12 months. Subgroup analyses will compare responses stratified by gender, years in practice, race and site	12 months prior to intervention
Primary	Number of PCPs that have confidence in discussing prostate issues during the the intervention	Analyses of graphing mean trajectories in response to repeat surveys among PCPs at baseline, 3, 6, 9 and 12 months. Subgroup analyses will compare responses stratified by gender, years in practice, race and site	12 months after intervention
Primary	Number of patients referred to specialty care 12 months prior to patient navigation/ care coordination	Review electronic medical records for referral to specialty care	12 months prior to intervention
Primary	Number of patients referred to specialty care through patient navigation/ care coordination during the intervention	Review electronic medical records for referral to specialty care	12 months after intervention