Decision Support Tool for Colorectal Cancer

Overseen By Suzanne Suzanne Brodney

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: High risk of CRC

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

Compensation: Varies

Number of Visits: Unknown

80000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool to help individuals make informed decisions about colorectal cancer (CRC) screening. The aim is to determine if using this CRC decision tool before a doctor's visit increases the completion rate of CRC screenings. Individuals aged 45 to 75, who are overdue for a CRC screening and have an upcoming regular check-up, may be suitable candidates. The trial compares those using the tool to those who do not, to assess its impact. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance CRC screening processes for many individuals.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this decision support tool is safe for colorectal cancer screening?

Research shows that tools designed to assist with colorectal cancer (CRC) screening decisions are generally safe and easy to use. Past studies have demonstrated that these tools help patients understand their screening options without causing harm. For instance, the CRISP trial used a similar tool and found no negative effects on participants.

These tools are typically digital aids that help patients make informed healthcare decisions. They do not involve medication or physical procedures, resulting in fewer safety concerns compared to other medical treatments. Overall, using these decision support tools is considered a safe way to encourage more people to complete CRC screenings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CRC decision tool because it offers a personalized approach to managing colorectal cancer. Unlike traditional treatment methods that often follow a one-size-fits-all strategy, this tool provides tailored decision support, helping patients and doctors make informed choices based on individual needs and circumstances. By integrating patient-specific data and preferences, it aims to enhance the decision-making process, potentially leading to better outcomes and improved patient satisfaction.

What evidence suggests that this decision support tool is effective for increasing CRC screening completion rates?

Research has shown that tools designed to aid decision-making can increase colorectal cancer (CRC) screening rates. In this trial, participants in the experimental arm will use the CRC decision tool, which assists patients in making informed choices about CRC screening, potentially improving follow-through. The CRISP trial found that using a risk assessment tool during regular doctor visits led to more screenings appropriate for each person's risk level. Other studies suggest that combining these decision aids with broader healthcare system changes can enhance screening completion. Overall, decision support tools have shown promise in increasing CRC screening rates by guiding patients through their options. ^{3 4 6 7 8}

Who Is on the Research Team?

Karen Sepucha, PhD

Principal Investigator

MGH

Karen Blumenthal, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 45-75 who are overdue for colorectal cancer (CRC) screening and at average risk. They must have an upcoming annual visit with participating primary care practices.

Inclusion Criteria

I am between 45-75 years old and overdue for a colon cancer screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use a CRC screening decision support tool as part of their primary care visit

6 months

Annual visit (in-person or virtual)

Follow-up

Participants are monitored for CRC screening completion and surveyed about decision-making involvement

12 months

What Are the Treatments Tested in This Trial?

Interventions

• CRC decision tool

Trial Overview The study tests if a CRC screening decision support tool, given before primary care visits, can increase the rates of completed CRC screenings. It evaluates how well the tool helps patients make informed choices and complete their preferred screening method.

How Is the Trial Designed?

Group I: CRC decision tool Experimental Treatment 1 Intervention

intervention arm

Group II: control Active Control 1 Intervention

control arm

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

The implementation of a decision support tool (DST) for cancer treatment showed little effect on overall survival (OS) among 1,059 patients with breast, colorectal, and lung cancer, indicating that process improvements may not lead to better patient outcomes.

Despite high adherence to evidence-based treatment recommendations (over 90% after DST implementation), the largest survival benefit observed was only 1.7 months for lung cancer patients, suggesting that existing treatment practices were already effective prior to the DST's introduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival After Implementation of a Decision Support Tool to Facilitate Evidence-Based Cancer Treatment. Ojha, RP., Lu, Y., Narra, K., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3480321/

Effectiveness of a Web-Based Colorectal Cancer ... Future research should focus on ways decision aids such as CHOICE can be combined with other system-level interventions to increase CRC screening.

2. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=22719602

Impact of a Decision Aid on Colorectal Cancer Screening The investigators hypothesized that adding the YDR tool might result in higher rates of screening completion than using the decision aid alone ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0010482525011060

A decision support model for colorectal cancer screening ... CRC predictive models that form the foundation of decision-support tools for screening. In particular, Bayesian Networks (BNs) [10] are used to infer the ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822774

Shared Decision-Making in Colorectal Cancer Screening ... To date, only a few studies have examined patient education and SDM tools to promote deimplementation of tests or treatments. Deimplementation ...

5. bjgp.org bjgp.org/content/73/733/e556

The Colorectal cancer RISk Prediction (CRISP) trial This randomised controlled trial found that using the Colorectal cancer RISk Prediction (CRISP) risk tool in general practice can increase risk-appropriate CRC ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10098832/

The Colorectal cancer RISk Prediction (CRISP) trial The Colorectal cancer RISk Prediction (CRISP) trial: a randomised controlled trial of a decision support tool for risk-stratified colorectal cancer screening.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06625983

Use of a Colorectal Cancer Screening Decision Support ... A structured online system, such as the ClinicalTrials.gov results ... The decision support tool guides patients through the CRC screening options ...

8. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-018-0691-x

A patient-oriented clinical decision support system for CRC ... Currently, there are several available online tools for CRC risk score prediction. Colorectal Cancer Risk Assessment Tool (CCRAT) (https:// ...