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

30 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{3 5 6 11 12}

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

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States 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. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Colorectal cancer surveillance by colonoscopy in a prospective, population-based long-term Swiss screening study - outcomes, adherence, and costs. [2022]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of fecal immunochemical tests for colorectal cancer screening. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Enhancing the use and quality of colorectal cancer screening. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Colorectal Cancer in the Young: Does Screening Make Sense? [2020]

8. England pubmed.ncbi.nlm.nih.gov

Colorectal cancer screening participation among citizens not recommended to be screened: a cohort study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Colorectal Cancer Screening. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Emerging technologies in colorectal cancer screening. [2005]

11. England pubmed.ncbi.nlm.nih.gov

Current status of screening for colorectal cancer. [2022]

12. United States 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. [2022]