Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings

NCT05785780 | Enrolling By Invitation DMC

• 3 other identifiers: 002056Pro2020002075R00CA256043
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to optimize CRC screening for patients with diabetes in primary care safety-net settings.

Conditions

Colorectal Cancer Screening; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Colonoscopy uptake

  Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy

  12 months

• Up-to-date CRC screening

  Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening

  12 months

Secondary Outcomes (1)

• Rate of CRC Screening Uptake by Glucose Control (Controlled vs. Uncontrolled) Among Participants with Type 2 Diabetes

  12 months

Other Outcomes (2)

• Participant Acceptability

  12 months

• Implementation Fidelity

  12 months

Study Arms (1)

Targeted CRC Screening Toolkit

EXPERIMENTAL

Based on national survey data and a community engagement participatory implemention planning group, a tailored combination of widely accepted implementation strategies will be adapted for targeting CRC screening for patients with diabetes. These strategies include but are not limited to: identification of patient and practice-level barriers, patient education, provider reminders, and audit and feedback.

Behavioral: Targeted CRC Screening Toolkit

Interventions

Targeted CRC Screening Toolkit BEHAVIORAL

Strategies in the toolkit include but are not limited to: identification of patient and practice-level barriers, routine tailored patient reminders, provider reminders, \& clinic staff feedback.

Targeted CRC Screening Toolkit

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of diabetes mellitus;
• Participants not up-to-date with CRC screening based on electronic health record (e.g. FOBT/FIT in last year; flexible sigmoidoscopy within four years; or colonoscopy within nine years);
• Age-eligible for CRC screening (50-74 years of age);
• Participants in process of undergoing screening are eligible for participation if they have a FIT/FOBT incomplete test ordered for more than six months or a sigmoidoscopy or colonoscopy referral not completed for greater than one year.

You may not qualify if:

• Medical conditions not concordant with standard CRC screening intervals (e.g. prior CRC diagnosis, inflammatory bowel disease, renal failure, etc.).

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Rutgers, The State University of New Jersey: lead

Study Sites (1)

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Related Publications (1)

• O'Malley DM, Crabtree BF, Kaloth S, Ohman-Strickland P, Ferrante J, Hudson SV, Kinney AY. Strategic use of resources to enhance colorectal cancer screening for patients with diabetes (SURE: CRC4D) in federally qualified health centers: a protocol for hybrid type ii effectiveness-implementation trial. BMC Prim Care. 2024 Jul 5;25(1):242. doi: 10.1186/s12875-024-02496-0.

  PMID: 38969987 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Denalee O'Malley, PhD

  Rutgers Robert Wood Johnson Medical School; Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study uses a pilot, pre-post, hybrid effectiveness-implementation design to compare the adapted implementation strategy to usual care on: (1) effectiveness and (2) implementation outcomes.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)