Protect Your Colon™ Decision Aid for Colorectal Cancer Screening

Overseen By Muskaan R Mehra, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Non-English speakers, No internet, others

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

Compensation: Varies

Number of Visits: 2

184 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a tool called Protect Your Colon™ can help individuals make better choices about colorectal cancer (CRC) screening by aligning tests with their personal values. It compares the usual care with this decision aid, which aims to improve communication and encourage follow-through with screening. Individuals who have never had a CRC screening or are overdue, aged 45 to 75, and not at high risk for CRC, may be suitable for this study. Participants will use the Protect Your Colon™ website to receive personalized recommendations before their doctor visits. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance CRC screening experiences for many.

Will I have to stop taking my current medications?

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

What prior data suggests that the Protect Your Colon™ decision aid is safe for colorectal cancer screening?

Research has shown that decision aids like Protect Your Colon™ are generally safe. These tools assist individuals in making informed health care decisions. In past studies, users of these aids reported better knowledge and greater satisfaction with their decisions, with no reports of harmful side effects.

Protect Your Colon™ is a decision aid specifically designed for colorectal cancer screening. It helps individuals understand their options and select tests that align with their preferences. Studies have demonstrated that these aids can increase screening rates by up to 14 percentage points.

Currently, no evidence suggests any negative effects from using Protect Your Colon™. It primarily focuses on enhancing communication and aiding individuals in making the right choices for themselves. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Protect Your Colon™ decision aid because it offers a personalized approach to colorectal cancer screening, which is different from the standard of care that often involves generalized discussions without a tailored focus. Unlike typical screening options where decisions are made spontaneously during clinic visits, Protect Your Colon™ provides patients with a customized report that aligns screening tests with their personal values and priorities. This method empowers patients to make informed decisions and actively engage in their healthcare, potentially leading to higher screening uptake and satisfaction. By enhancing patient-doctor communication with a structured, pre-visit tool, researchers hope to improve screening rates and early detection of colorectal cancer.

What evidence suggests that the Protect Your Colon™ decision aid is effective for increasing colorectal cancer screening uptake?

Research has shown that tools like Protect Your Colon™, which participants in this trial may use, can greatly increase colorectal cancer screening rates. One review found that these tools improve patients' understanding by about 20% compared to those who didn't use them. In a specific study, 43% of patients aged 50-75 who used Protect Your Colon™ completed their screening tests within six months. This tool also enhances satisfaction with the decision-making process. When patients use decision aids, they are more likely to make informed choices and select the screening test that best fits their needs. ^{1 2 3 5 6}

Who Is on the Research Team?

Christopher V Almario, MD, MSHPM

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals aged 45 to 75 who have never been screened for colorectal cancer (CRC) and are not at high risk due to conditions like inflammatory bowel disease or family history of CRC.

Inclusion Criteria

I am between 45 and 75 years old.

I have never had screening for colorectal cancer.

I am not at high risk for colorectal cancer due to conditions like IBD or family history.

Exclusion Criteria

Does not have internet access

Any records flagged 'break the glass' or 'research opt out.'

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the Protect Your Colon™ decision aid and review personalized reports before their clinic visit

2 days

1 visit (in-person)

Follow-up

Participants are monitored for CRC screening uptake and complete a questionnaire on their screening experience

6 months

1 visit (in-person), 1 follow-up questionnaire (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Protect Your Colon™

Trial Overview The trial is testing 'Protect Your Colon™', a decision aid designed to help patients choose the most suitable CRC screening test based on their values, with the goal of increasing overall screening rates.

How Is the Trial Designed?

Group I: Protect Your Colon™ (Intervention) Experimental Treatment 1 Intervention

Patients randomized to Protect Your Colon™ will be directed to go through the website before their clinic appointment. Those who finish the decision aid will then review their personalized report which details their priorities in selecting a screening test as well as the test that best matches their values. Patients will also be encouraged to bring their personalized report with them to the visit to discuss with their doctor. All intervention participants will also receive a reminder via email one day before their scheduled clinic visit. They will be reminded to go through the Protect Your Colon™ website before the clinic visit and to bring their personalized report with them to the visit.

Group II: Usual Care (Control) Active Control 1 Intervention

The usual care group will be managed according to the providers' customary practices: CRC screening discussions, if any, are at the discretion of the provider as Cedars-Sinai does not employ a standardized approach. Patients randomized to the control arm will not be sent any materials before their clinic appointment.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A computer-based decision aid significantly increased patients' intent to request colorectal cancer screening, with scores rising from 2.8 to 3.2 after viewing the aid, indicating a strong positive impact on patient motivation.

Within 6 months of using the decision aid, 43% of patients aged 50-75 completed their screening tests, demonstrating the aid's effectiveness in translating increased interest into actual screening behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial testing of a computer-based patient decision aid to promote colorectal cancer screening for primary care practice. Kim, J., Whitney, A., Hayter, S., et al.[2019]

Decision aids significantly enhance patients' knowledge about colorectal cancer screening, with an average increase of 18.3 points on a 100-point scale compared to control groups, based on a review of 21 trials involving 11,900 subjects.

Patients using decision aids were 1.5 times more likely to express interest in screening and 1.3 times more likely to actually undergo screening compared to those who received no information, although their screening rates were similar to those who received general information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Decision Aids for Colorectal Cancer Screening: A Systematic Review and Meta-analysis. Volk, RJ., Linder, SK., Lopez-Olivo, MA., et al.[2022]

Implementing a centralized delivery system for colorectal cancer (CRC) decision aids (DAs) was feasible, with over 90% of participants recalling receiving the DA and 80% finding it helpful for decision-making.

Despite the increase in CRC screening knowledge due to the DA, overall screening rates actually decreased from 50.8% to 39.2%, indicating that while DAs can enhance understanding, their effectiveness in increasing actual screening rates may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of a Novel Colorectal Cancer Decision Aid Using a Centralized Delivery Strategy. Tate, CE., Matlock, DD., Dalton, AF., et al.[2019]

Including an explicit discussion of the option not to be screened in a colon cancer screening decision aid led to lower perceived clarity and overall ratings compared to a version that did not include this option, indicating a trade-off in how the information is presented.

Despite differences in subjective measures of clarity and balance, there were no significant changes in participants' interest in screening or their knowledge about colon cancer screening after viewing either version of the decision aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should a colon cancer screening decision aid include the option of no testing? A comparative trial of two decision aids. Griffith, JM., Fichter, M., Fowler, FJ., et al.[2021]

A web-based decision aid significantly increased colorectal cancer screening uptake by 8 percentage points among non-participants, indicating its effectiveness in encouraging screening.

While the decision aid did not improve knowledge or attitudes towards screening, it successfully reduced decisional conflict, suggesting it helps individuals feel more confident in their choice to participate in screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial. Gabel, P., Larsen, MB., Edwards, A., et al.[2021]

The pilot study involving 96 patients showed that a decision aid based on multicriteria decision-making significantly reduced decisional conflict among patients regarding colorectal cancer screening, leading to increased knowledge and clarity in their decision-making process.

Despite improvements in the decision-making process, the use of the decision aid did not result in a higher rate of completed screening tests, with 52% of the control group and 49% of the experimental group completing their plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a patient decision aid for colorectal cancer screening. Dolan, JG., Frisina, S.[2019]

Colorectal cancer screening is effective in reducing both incidence and mortality, yet less than 60% of eligible adults are up to date with screenings due to various barriers.

Implementing patient decision aids can significantly increase screening rates by up to 14 percentage points, and mailing these aids to patients before their office visits is a cost-effective strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using quality improvement techniques to increase colon cancer screening. Pignone, MP., Lewis, CL.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5067222/

Patient Decision Aids for Colorectal Cancer Screening This review found that decision aids for CRC screening improve patients' knowledge by about 20% compared with control conditions and general CRC screening ...

2. withpower.com withpower.com/trial/phase-colorectal-neoplasms-7-2023-f39ed

Protect Your Colon™ Decision Aid for Colorectal Cancer ... Within 6 months of using the decision aid, 43% of patients aged 50-75 completed their screening tests, demonstrating the aid's effectiveness in translating ...

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

Impact of a Decision Aid on Colorectal Cancer Screening The study showed an increase in ordered CRC screening tests, completed CRC screening tests, satisfaction with the decision-making process, CRC ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0241703

Effectiveness of a decision aid for colorectal cancer screening ... The aim of this study was to evaluate the effectiveness of a web-based decision aid for colorectal cancer screening on components of informed choice.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2799194

Effect of a Patient Decision Aid on Preferences for ... From the patient perspective, use of a decision aid may be able to modify older adult preferences to align with the potential to benefit from ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3966107/

Aid-Assisted Decision-Making and Colorectal Cancer ... This study finds that decision aid–assisted SDM has a modest impact on CRC screening uptake, even when provider and patient preferences differ. The findings ...