~5 spots leftby Sep 2025

CRC Screening Toolkit for Diabetes

Recruiting in Palo Alto (17 mi)
Overseen byDenalee O'Malley, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rutgers, The State University of New Jersey
Disqualifiers: Prior CRC, Inflammatory bowel, Renal failure, others
No Placebo Group

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.

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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.

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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.

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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.
+1 more

Exclusion Criteria

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

Trial 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

Participant Groups

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.
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

Research Locations NearbySelect from list below to view details:
RWJBarnabas Health - Robert Wood Johnson University HospitalNew Brunswick, NJ
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Who Is Running the Clinical Trial?

Rutgers, The State University of New JerseyLead Sponsor
National Cancer Institute (NCI)Collaborator

References

Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial. [2022]Colorectal cancer (CRC) screening reduces CRC mortality; however, screening rates remain well below the national benchmark of 80%.
Colorectal cancer surveillance by colonoscopy in a prospective, population-based long-term Swiss screening study - outcomes, adherence, and costs. [2022]The success of colorectal cancer (CRC) screening depends mainly on screening quality, patient adherence to surveillance, and costs. Consequently, it is essential to assess the performance over time.
Impact of Risk Assessment and Tailored versus Nontailored Risk Information on Colorectal Cancer Testing in Primary Care: A Randomized Controlled Trial. [2020]Colorectal cancer screening is effective but underused. Guidelines for which tests are recommended and at what intervals depend on specific risks. We developed a tablet-based Cancer Risk Intake System (CRIS) that asks questions about risk prior to appointments and generates tailored printouts for patients and physicians summarizing and matching risk factors with guideline-based recommendations.
Evaluation of fecal immunochemical tests for colorectal cancer screening. [2021]Colorectal cancer (CRC) screening reduces the mortality due to CRC. It is important for health care providers to be aware of the variation in the products available for CRC screening.
Enhancing the use and quality of colorectal cancer screening. [2022]To conduct a systematic review of the use and quality (including underuse, overuse, and misuse) of appropriate colorectal cancer (CRC) screening, including factors associated with screening, effective interventions to improve screening rates, current capacity, and monitoring and tracking the use and quality. Trends in the use and quality of CRC screening tests is also presented.
Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. [2022]The English National Health Service Bowel Cancer Screening Programme (NHSBCSP) is one of the world's largest organized screening programs. Minimizing adverse events is essential for any screening program. Study aims were to determine rates and to examine risk factors for adverse events.
Colorectal Cancer in the Young: Does Screening Make Sense? [2020]Colorectal cancer (CRC) screening is recommended to reduce CRC mortality. This review outlines key factors to consider when recommending screening, including disease burden, screening benefits and harms, and remaining knowledge gaps.
Colorectal cancer screening participation among citizens not recommended to be screened: a cohort study. [2023]Guidelines on colorectal cancer (CRC) screening recommend screening of average-risk adults only. In addition, screening of individuals with active inflammatory bowel disease (IBD) might result in too many false-positive cases. However, the organisers of CRC screening programmes are often uninformed of whom to exclude due to an elevated CRC risk or active IBD. It is therefore unknown how often high-risk individuals (i.e. individuals with a previous diagnosis of CRC or polyps associated with hereditary CRC syndromes and certain patient groups with a diagnosis of inflammatory bowel disease (IBD) or multiple polyps) and individuals with active IBD participate in CRC screening following invitation.
Colorectal Cancer Screening. [2017]Colorectal cancer (CRC) continues to be one of the most commonly diagnosed cancers and contributes significantly to many cancer-related deaths despite sustained progress in diagnostic and treatment options. Many forms of CRC can be prevented through early and routine screening, when precancerous lesions may be detected and removed before they undergo malignant transformation or metastasis. Despite widespread efforts to improve CRC screening rates, at least 40% of age-eligible adults do not adhere to screening guidelines. A new generation of noninvasive, molecular-based diagnostic tests with high sensitivities and specificities has the potential to improve screening rates through optimal risk stratification of patients who may benefit from more invasive screening techniques. This review presents various guidelines and methods that are currently available for CRC screening, summarizes the rationale behind utilization of novel molecular-based diagnostic tests for CRC screening and prevention, and discusses appropriate screening techniques and intervals in populations of varying risk.
10.United Statespubmed.ncbi.nlm.nih.gov
Emerging technologies in colorectal cancer screening. [2005]CRC is a preventable disease through early detection, yet screening rates remain low and mortality rates remain high. The discomfort associated with the preparation and performance of some of the currently available screening modalities and the lack of public awareness about CRC and screening procedures likely account for low rates of screening. CT colonography and stool DNA testing are new promising screening technologies that are less invasive, accurate, and suitable for the public more than the current screening procedures. Before both tests can be promoted for population-based screening programs, several issues that have been detailed in this article must be addressed further, including technical improvements for improving accuracy, development of virtual preparation, test availability, patient and provider acceptability and cost-effectiveness for CTC, and identifying the optimal combination of molecular targets for stool DNA testing. The year 2005 will tell us if the ideal technology from the public health point of view was achieved. A skill-independent, anesthesia-free, self-propelling, self-navigating miniaturized endoscopic device that may move along the entire length of the colon may change the natural history of CRC. We should aim to achieve a new definition of CRC--a rare disease occurring in a subset of the population who has not been screened for the disease.
Current status of screening for colorectal cancer. [2022]Colorectal cancer (CRC) is a leading cause of cancer morbidity and mortality. A well-defined precursor lesion (adenoma) and a long preclinical course make CRC a candidate for screening. This paper reviews the current evidence for the most important tests that are widely used or under development for population-based screening.
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]In the United States, colorectal cancer (CRC) is the third most common cancer diagnosed among men and women and the second leading cause of death from cancer. CRC largely can be prevented by the detection and removal of adenomatous polyps, and survival is significantly better when CRC is diagnosed while still localized. In 2006 to 2007, the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology came together to develop consensus guidelines for the detection of adenomatous polyps and CRC in asymptomatic average-risk adults. In this update of each organization's guidelines, screening tests are grouped into those that primarily detect cancer early and those that can detect cancer early and also can detect adenomatous polyps, thus providing a greater potential for prevention through polypectomy. When possible, clinicians should make patients aware of the full range of screening options, but at a minimum they should be prepared to offer patients a choice between a screening test that primarily is effective at early cancer detection and a screening test that is effective at both early cancer detection and cancer prevention through the detection and removal of polyps. It is the strong opinion of these 3 organizations that colon cancer prevention should be the primary goal of screening.