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

Trial Summary

What is the purpose of this trial?

The research question we pose is, Does a colorectal cancer (CRC) screening decision support tool offered in advance of primary care visits increase CRC screening completion rates? Our work aims to answer this question by evaluating the effectiveness of an MGB decision support tool to 1) promote informed decisions about CRC screening for average risk patients ages 45-75, 2) deploy a decision support tool as part of a primary care bundle questionnaire, and 3) support patients in completing their preferred method of CRC screening.

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 data supports the effectiveness of the treatment CRC decision tool?

Research shows that decision support tools can help improve the process of cancer treatment, and there is some evidence suggesting they might also improve patient survival for colorectal cancer. ^{1 2 3 4 5}

How is the Decision Support Tool for Colorectal Cancer treatment different from other treatments?

The Decision Support Tool for Colorectal Cancer is unique because it is a computerized system designed to help patients make informed decisions about adjuvant chemotherapy for stage II colorectal cancer, focusing on patient involvement rather than solely physician-directed decision-making. ^{1 4 6 7 8}

Research Team

Karen Blumenthal, MD

Principal Investigator

Mass General Brigham

Karen Sepucha, PhD

Principal Investigator

MGH

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A patient-oriented clinical decision support system for CRC risk assessment and preventative care. [2019]

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

Survival After Implementation of a Decision Support Tool to Facilitate Evidence-Based Cancer Treatment. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A matter of trust--patient's views on decision-making in colorectal cancer. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Key elements of optimal treatment decision-making for surgeons and older patients with colorectal or pancreatic cancer: A qualitative study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Consumer impact of an interactive decision aid for rectal cancer patients offered adjuvant therapy. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Use of a computerised decision aid (DA) to inform the decision process on adjuvant chemotherapy in patients with stage II colorectal cancer: development and preliminary evaluation. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

CorRECTreatment: a web-based decision support tool for rectal cancer treatment that uses the analytic hierarchy process and decision tree. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Implementing patient decision support tools: moving beyond academia? [2015]