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Trial record 71 of 477 for:    colon cancer | ( Map: Texas, United States )

PROSPR Project 1: Identifying and Tracking Personalized CRC Screening Regimens for Patients in Clinical Settings

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ClinicalTrials.gov Identifier: NCT03705897
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
The overall goal of the Parkland-UT Southwestern Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) Center is to optimize colon cancer screening through personalized regimens in the integrated safety-net clinical provider network, which serves a large and diverse population of under- and un-insured patients in Dallas. Together, three research projects will assess clinic, system, and organizational factors associated with over-, under- and guideline-based screening among this important population and will compare benefits, harms, and costs of strategies for facilitating optimized screening regimens. The theme of optimizing colorectal cancer screening in a safety-net clinical provider network brings together several components. Its focus on colorectal cancer (CRC) screening which is important, because CRC is the second cancer killer in the US while being the only major cancer for which optimized screening results in primary prevention. Despite this strong potential benefit, CRC screening remains suboptimal overall, and especially among low-income and minority individuals served by safety-nets. Safety-net networks therefore offer tremendous potential for CRC prevention and control, but numerous factors at the clinics-, system-, and organization-level influence their ability to provide optimized care.

Condition or disease Intervention/treatment Phase
ColoRectal Cancer Other: Computerized Risk Stratification Tool Other: Algorithmic Risk Stratification Tool Other: Step completion assessment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9865 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: PROSPR Project 1: Identifying and Tracking Personalized CRC Screening Regimens for Patients in Clinical Settings
Study Start Date : August 2013
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Screening
Employ innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening. Interventions include Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool, and Step completion assessment.
Other: Computerized Risk Stratification Tool
Implement a novel computerized risk stratification tool in Parkland community-oriented primary-care clinics that collects data directly from patients and uses a computerized algorithm system to generate their personalized guideline-based next steps in the screening regimen

Other: Algorithmic Risk Stratification Tool
Implement a novel algorithmic risk stratification system in Parkland's endoscopy clinics that, based on test findings entered by colonoscopists, generates personalized guideline-based next steps in the screening regimen for patients with colorectal polyps removed at olonoscopy

Other: Step completion assessment
Assess completion of guideline-recommended steps in personalized screening regimens, under-screening, and over-screening




Primary Outcome Measures :
  1. Proportion of patients achieving appropriate screening regimen. [ Time Frame: Three years ]
    Proportion of patients achieving appropriate screening regimen.



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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female patients, ages 25-64, presenting for appointment will be eligible to participate.
  • Patients 25-49 must also have family hx of CRC or personal hx of inflammatory bowel disease or adenomatous polyps.
  • No racial or ethnic group will be excluded from participation.
  • Both English and Spanish speakers will be eligible for participation.

Exclusion Criteria:

  • Patients with a personal history of CRC are not eligible to participate.
  • Patients who do not speak Spanish or English or have severely impaired hearing or speech or do not give informed consent will also be excluded from participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705897


Contacts
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Contact: Celette Skinner, PhD 214-648-5499 celette.skinner@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Celette Skinner, PhD    214-648-5499    celette.skinner@utsouthwestern.edu   
Contact: Katharine McCallister, PhD    214-648-2973    katharine.mccallister@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Celette Skinner, PhD UT Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03705897     History of Changes
Other Study ID Numbers: SCCC-14311
STU 102011-068 ( Other Identifier: UT Southwestern Medical Center )
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases