Colorectal Cancer Control and PreventionNCT06625983
Use of a Colorectal Cancer Screening Decision Support Tool in Primary Care
A study testing CRC decision tool in people with Colorectal Cancer Control and Prevention and Colorectal Cancer Screening, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Control and Prevention, Colorectal Cancer Screening, Shared Decision Making
- What is being tested?
- CRC decision tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,205 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2024to 1 Jan 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 45-75 overdue for CRC screening at average risk of CRC have an annual visit scheduled with participating practices
Who cannot join
- high risk of CRC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colorectal Cancer Screening Decision Support Tool in the Primary Care Bundle Questionnaire
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.
Read the detailed description
As part of usual care, a CRC screening electronic decision support tool developed by Mass General Brigham has been integrated into Epic. This decision support tool is part of routine clinical care and is sent electronically to patients aged 45-75 who receive the Annual Visit Primary Care Screening Bundled Questionnaire in advance of their annual visit. Patients complete the tool on Patient Gateway prior to the visit or via an iPad at the visit. The decision support tool guides patients through the CRC screening options (e.g., FIT, colonoscopy, Cologuard) to help them select their preferred screening method. As part of routine care, the patient will be prompted to complete the tool as part of the bundled questionnaire, and the results will be available in the Epic encounter in the Screenings tab with the other screening bundle responses. The primary care clinician can then discuss the options and/or screening preference with the patient. Depending on what the patient and clinician decide, a CRC screening test may be ordered for the patient. As a secondary outcome, a random sample of 1000 patients will be surveyed to understand their involvement in the decision making process and 300 providers will be surveyed to understand how the decision tool impacted the conversation with the patient. The IRB to conduct surveys of patients and providers was approved by the Mass General Brigham IRB (Protocol # 2024P002568).
- Conditions
- Colorectal Cancer Control and Prevention, Colorectal Cancer Screening, Shared Decision Making, Decision Aid
- Being tested
- CRC decision tool
- Keywords
- colorectal cancer screening, shared decision making, electronic health record, randomized controlled trial, decision tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRC decision toolOther
Also called intervention
CRC decision tool included in the primary care bundle questionnaire
| Study group | Role | What they receive |
|---|---|---|
| CRC decision tool | Experimental | intervention arm Receives: Other: CRC decision tool |
| control | No intervention | control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC screening completion
Assessment of electronic health record data to determine completion of CRC screening by any modality
Measured: 6 months
Secondary outcomes (2)
Provider Experience
Provider-reported question: Did you feel the CRC screening tool informed or affected your conversations in any way?
Measured: During the 6 month intervention phase
Shared Decision Making Process Measure
Patient-reported survey question about involvement in the decision making process.
Measured: During the 6 month intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start16 Oct 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Control and PreventionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Practices will be randomized to receive the decision tool or not receive the decision tool.
- Masking
- None (open label)
- Enrolment
- 9,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen J. Blumenthal, MD, MPH, Massachusetts General Hospital
- Investigators
- Karen Blumenthal, MD, Principal investigator, Massachusetts General HospitalKaren Sepucha, PhD, Study director, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625983
- Sponsor's protocol ID
- 2024P000687
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentified data will be made available upon request