CRC Screening Toolkit for Diabetes

Overseen By Cilgy Abraham

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Prior CRC, Inflammatory bowel, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a toolkit designed to improve colon cancer (CRC) screening for people with diabetes. It aims to identify the best ways for patients and healthcare providers to collaborate and ensure timely screenings. The Targeted CRC Screening Toolkit includes patient education, doctor reminders, and progress feedback. Individuals with diabetes who are behind on their colon cancer screenings might be suitable for this trial. As an unphased trial, it offers participants a unique opportunity to contribute to innovative strategies that could enhance healthcare outcomes for many.

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 prior data suggests that this toolkit is safe for optimizing CRC screening in patients with diabetes?

Research has shown that the Targeted CRC Screening Toolkit aims to improve colorectal cancer (CRC) screening for people with diabetes. This toolkit employs various methods, such as educating patients, reminding doctors, and providing feedback, to overcome screening obstacles.

The trial is labeled "Not Applicable" in phase, indicating that the toolkit is not a new drug or treatment that directly affects health. Instead, it seeks to enhance screening practices, which typically do not involve personal health risks. Safety concerns are minimal because it focuses on improving healthcare processes rather than introducing new medications or invasive procedures.

In summary, the toolkit is expected to be safe as it primarily involves educational and organizational strategies rather than direct medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Targeted CRC Screening Toolkit because it offers a customized approach to colorectal cancer screening specifically for patients with diabetes. Unlike standard screening methods that are one-size-fits-all, this toolkit uses a tailored combination of strategies, such as identifying individual and practice-level barriers, providing patient education, and reminding healthcare providers about screenings. By focusing on personalized implementation strategies, this toolkit aims to improve screening rates and outcomes among diabetic patients, who might face unique challenges.

What evidence suggests that the Targeted CRC Screening Toolkit is effective for optimizing CRC screening in patients with diabetes?

Research shows that tools like the Targeted CRC Screening Toolkit, which participants in this trial will use, can increase colorectal cancer (CRC) screening, particularly for people with diabetes. This toolkit uses various methods, such as identifying barriers for patients and doctors, educating patients, reminding doctors, and providing feedback. Studies have shown that these personalized methods can boost screening rates, which is crucial because early detection of CRC can prevent it. In primary care settings, especially those in under-resourced areas, these strategies optimize resources and improve health outcomes. Overall, evidence supports that this approach can significantly increase CRC screening rates. ^{1 2 4 5 6}

Who Is on the Research Team?

Denalee O'Malley, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Targeted CRC Screening Toolkit

Trial Overview The 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.

How Is the Trial Designed?

Group I: Targeted CRC Screening Toolkit Experimental Treatment 1 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.

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+

Published Research Related to This Trial

Colorectal cancer (CRC) is a leading cause of cancer-related deaths, but many cases can be prevented through early screening to detect and remove precancerous lesions.

New noninvasive molecular-based diagnostic tests show promise in improving CRC screening rates by accurately identifying patients at risk, which could lead to better adherence to screening guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal Cancer Screening. Bray, C., Bell, LN., Liang, H., et al.[2017]

The American Cancer Society now recommends colorectal cancer screening starting at age 45 due to rising incidence rates among younger adults, although there is limited evidence on the effectiveness and potential harms of screening in this age group.

There is a need for more research on the natural history of colorectal cancer in younger adults and the potential benefits of precision cancer screening, which tailors screening based on individual risk rather than just age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal Cancer in the Young: Does Screening Make Sense? Murphy, CC.[2020]

A study analyzing fecal immunochemical tests (FIT) from four proficiency testing programs found that five out of fourteen evaluated FIT brands had high accuracy, with sensitivities between 98.1% and 98.8% and specificities from 98.1% to 99.6%.

Despite the overall good performance of some FIT products, about one-third of the tests showed low sensitivity and specificity, indicating that not all FIT products are suitable for widespread colorectal cancer screening and further evaluation is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of fecal immunochemical tests for colorectal cancer screening. Daly, JM., Bay, CP., Levy, BT.[2021]

Colorectal cancer (CRC) screening is often underused, with factors like low income, lack of insurance, and certain ethnic backgrounds contributing to lower screening rates, while higher income, insurance, and physician recommendations are linked to higher rates.

Effective interventions to improve CRC screening include patient reminders and one-on-one interactions, but purely educational efforts have not shown to be effective; however, there is a need for more research on reducing overuse and misuse of screening methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the use and quality of colorectal cancer screening. Holden, DJ., Harris, R., Porterfield, DS., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Screening for colorectal cancer (CRC) is crucial for prevention, but current methods are underutilized due to discomfort and lack of awareness; new technologies like CT colonography and stool DNA testing offer less invasive and more accurate alternatives.

Before these new screening methods can be widely adopted, issues such as accuracy, preparation, availability, acceptability, and cost-effectiveness need to be resolved, with the potential for a revolutionary miniaturized endoscopic device to significantly improve CRC screening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging technologies in colorectal cancer screening. Moshkowitz, M., Arber, N.[2005]

Repetitive faecal occult blood testing (FOBT) has been shown to reduce colorectal cancer (CRC) mortality by 16%, while once-only flexible sigmoidoscopy (FS) reduces mortality by 28% and also decreases CRC incidence by 18%.

Colonoscopy may have a greater impact on CRC incidence and mortality, but there is currently a lack of randomized trials to confirm its effectiveness, highlighting the need for further research on new screening methods before they can be widely implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of screening for colorectal cancer. Garborg, K., Holme, Ø., Løberg, M., et al.[2022]

Colorectal cancer (CRC) is a major health concern in the U.S., being the third most common cancer and the second leading cause of cancer death, but it can largely be prevented through early detection and removal of adenomatous polyps.

Updated guidelines emphasize that screening should focus on both early cancer detection and the prevention of cancer by identifying and removing polyps, with clinicians encouraged to inform patients about all available screening options.

NCBI (Pubmed)

pubmed.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. Levin, B., Lieberman, DA., McFarland, B., et al.[2022]

In a study analyzing 130,831 colonoscopies, the overall bleeding rate was found to be 0.65%, with a very low rate of bleeding requiring transfusion (0.04%) and perforation (0.06%), indicating that the NHS bowel cancer screening program is relatively safe.

The study identified that larger polyp size and cecal location significantly increase the risk of adverse events, with cecal polypectomy showing a 13.5-fold increased risk of bleeding requiring transfusion and a 12.2-fold increased risk of perforation compared to distal colon procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. Rutter, MD., Nickerson, C., Rees, CJ., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 the Danish CRC screening program, 28-48% of high-risk individuals and 55% of those with inflammatory bowel disease (IBD) participated in screening, despite guidelines recommending against it for these groups.

The screening program revealed that while the average participation rate was 67% among individuals without previous colorectal disease, those with a history of CRC or IBD had a higher rate of positive FIT test results (7.7-14.8%), indicating a potential need for reevaluation of screening guidelines for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer screening participation among citizens not recommended to be screened: a cohort study. Larsen, PT., Jørgensen, SF., Njor, SH.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/431096

Aim 3, Optimizing CRC Screening in Patients With ... This mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11225128/

Strategic use of resources to enhance colorectal cancer ... Strategies to effectively prioritize and optimize CRC screening for patients with diabetes in the primary care safety-net are needed.

3. ancora.ai ancora.ai/en/details/NCT05785780

Aim 3, Optimizing CRC Screening in Patients With ... This mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to optimize CRC screening.

4. careacross.com careacross.com/clinical-trials/trial/NCT05785780

Aim 3 Optimizing CRC Screening in Patients With Diabetes ... This mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to optimize CRC screening for ...

5. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10904675&term=CA256043

Division of Cancer Control & Population Sciences - Grant Details At the point that CRC is diagnosed in patients with diabetes opportunities to implement CRC screening tests demonstrated to be effective in preventing CRC and ...

6. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10620315&term=CA256043

Division of Cancer Control & Population Sciences - Grant Details ABSTRACT Patients with diabetes mellitus have an estimated 27% elevated risk of developing colorectal cancer (CRC) and are disproportionately Non-Hispanic ...