30 Participants Needed

CRC Screening Toolkit for Diabetes

DO
CA
Overseen ByCilgy Abraham
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Targeted CRC Screening Toolkit for diabetes?

The research highlights that colorectal cancer (CRC) screening is effective in reducing mortality and that tailored risk information can improve screening rates. This suggests that a targeted CRC screening toolkit, which likely includes personalized risk assessments, could be effective in increasing screening adherence and outcomes.12345

Is the CRC Screening Toolkit for Diabetes safe for humans?

The available research does not provide specific safety data for the CRC Screening Toolkit for Diabetes, but it emphasizes the importance of minimizing adverse events in colorectal cancer screening programs.14678

How does this treatment for colorectal cancer screening differ from others?

This treatment is unique because it uses a tablet-based system to assess individual risk factors and provide tailored screening recommendations, which can help improve adherence to screening guidelines compared to standard methods that do not personalize recommendations.39101112

Research Team

DO

Denalee O'Malley, PhD

Principal Investigator

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

Eligibility Criteria

This trial is for people aged 50-74 with diabetes who are overdue for colorectal cancer (CRC) screening. They must not be up-to-date with CRC tests and can join even if they've started but not finished screening over six months ago. It's not open to those with conditions like past CRC, inflammatory bowel disease, or renal failure.

Inclusion Criteria

You have not had the recommended colon cancer screening tests within the specified timeframes.
I have been referred for a colon cancer screening test but haven't completed it.
I am between 50 and 74 years old.
See 1 more

Exclusion Criteria

I have a medical condition that affects when I should be screened for colorectal cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of targeted CRC screening strategies for patients with diabetes in safety-net primary care settings

12 months
Regular clinic visits as per implementation plan

Follow-up

Participants are monitored for safety and effectiveness after implementation

4 weeks

Treatment Details

Interventions

  • Targeted CRC Screening Toolkit
Trial OverviewThe study is testing a 'Targeted CRC Screening Toolkit' designed to improve the rate of CRC screenings in patients with diabetes within safety-net primary care settings. The approach involves interventions at patient, team, and organizational levels.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Targeted CRC Screening ToolkitExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

An electronic primer message sent through a patient portal significantly increased colorectal cancer (CRC) screening completion rates from 32.1% to 37.6% in a study of 2339 average-risk patients aged 50 to 75 years.
Patients who opened the electronic primer message had a 7.3% higher screening completion rate, and the time to complete screening was also shorter in the intervention group, indicating that digital reminders can effectively enhance participation in CRC screening programs.
Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial.Goshgarian, G., Sorourdi, C., May, FP., et al.[2022]
In a study of 1278 individuals aged 50 to 80 in Switzerland, 21.3% had adenomas and 6.5% had advanced adenomas, with those having advanced adenomas at screening being nearly five times more likely to develop further advanced adenomas.
Only 59.8% of participants adhered to follow-up colonoscopies, highlighting a need for improved long-term adherence strategies; additionally, the high costs of screening and follow-up suggest that less expensive screening methods for low-risk individuals could be beneficial.
Colorectal cancer surveillance by colonoscopy in a prospective, population-based long-term Swiss screening study - outcomes, adherence, and costs.Zgraggen, A., Stoffel, ST., Barbier, MC., et al.[2022]
The Cancer Risk Intake System (CRIS) significantly increased participation in colorectal cancer testing, with 47% of users participating compared to only 16% in the no-contact group, highlighting its effectiveness in promoting screening.
Tailored information provided to patients and their physicians through CRIS further enhanced testing participation among users aged 50 and older, with a notable increase from 44% to 53%, suggesting that personalized risk assessments can improve adherence to screening guidelines.
Impact of Risk Assessment and Tailored versus Nontailored Risk Information on Colorectal Cancer Testing in Primary Care: A Randomized Controlled Trial.Skinner, CS., Halm, EA., Bishop, WP., et al.[2020]

References

Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial. [2022]
Colorectal cancer surveillance by colonoscopy in a prospective, population-based long-term Swiss screening study - outcomes, adherence, and costs. [2022]
Impact of Risk Assessment and Tailored versus Nontailored Risk Information on Colorectal Cancer Testing in Primary Care: A Randomized Controlled Trial. [2020]
Evaluation of fecal immunochemical tests for colorectal cancer screening. [2021]
Enhancing the use and quality of colorectal cancer screening. [2022]
Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. [2022]
Colorectal Cancer in the Young: Does Screening Make Sense? [2020]
Colorectal cancer screening participation among citizens not recommended to be screened: a cohort study. [2023]
Colorectal Cancer Screening. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Emerging technologies in colorectal cancer screening. [2005]
Current status of screening for colorectal cancer. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. [2022]