Protect Your Colon™ Decision Aid for Colorectal Cancer Screening

Overseen By Antwon Chaplin, BA

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

Trial Summary

What is the purpose of this trial?

The purpose of the research is to assess the impact of Protect Your Colon™, a colorectal cancer (CRC) screening decision aid, on patients' CRC screening behaviors. The Investigators hypothesize that Protect Your Colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase CRC screening uptake. To test this hypothesis, the investigators will conduct a pilot randomized controlled trial (RCT) to assess if provision of Protect Your Colon™ improves communication on CRC screening, intent to complete screening, and ultimately uptake of screening vs. usual care.

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 data supports the effectiveness of the treatment Protect Your Colon™ for colorectal cancer screening?

The research shows that decision aids, like Protect Your Colon™, can help increase interest and participation in colorectal cancer screening by providing information and helping patients make informed choices. These aids have been shown to increase screening rates by up to 14 percentage points. ^{1 2 3 4 5}

How does the Protect Your Colon™ Decision Aid for Colorectal Cancer Screening differ from other treatments?

The Protect Your Colon™ Decision Aid is unique because it is a computer-based tool designed to help patients make informed decisions about colorectal cancer screening by increasing their knowledge and interest in screening options. Unlike traditional treatments, it focuses on patient education and decision-making rather than direct medical intervention. ^{1 2 4 6 7}

Research Team

Christopher V Almario, MD, MSHPM

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.'

I do not speak English.

Timeline

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)

Treatment Details

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.

Participant Groups

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

Patients randomized to Protect Your Colon™ will be directed to go through the website at least 2 days 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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Patient Decision Aids for Colorectal Cancer Screening: A Systematic Review and Meta-analysis. [2022]

2. England 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. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of a Novel Colorectal Cancer Decision Aid Using a Centralized Delivery Strategy. [2019]

4. United States 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. [2021]

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

Using quality improvement techniques to increase colon cancer screening. [2021]

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

Randomized controlled trial of a patient decision aid for colorectal cancer screening. [2019]

7. England 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. [2021]