Protect Your Colon™ Decision Aid for Colorectal Cancer Screening
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Cedars-Sinai Medical Center
Disqualifiers: Non-English speakers, No internet, others
No Placebo Group
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.
12345How 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.
12467Eligibility 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.
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Protect Your Colon™ (Intervention)Experimental Treatment1 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 Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Cedars-Sinai Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Patient Decision Aids for Colorectal Cancer Screening: A Systematic Review and Meta-analysis. [2022]Decision aids prepare patients to make decisions about healthcare options consistent with their preferences. Helping patients choose among available options for colorectal cancer screening is important because rates are lower than screening for other cancers. This systematic review describes studies evaluating patient decision aids for colorectal cancer screening in average-risk adults and their impact on knowledge, screening intentions, and uptake.
Development and initial testing of a computer-based patient decision aid to promote colorectal cancer screening for primary care practice. [2019]Although colorectal cancer screening is recommended by major policy-making organizations, rates of screening remain low. Our aim was to develop a patient-directed, computer-based decision aid about colorectal cancer screening and investigate whether it could increase patient interest in screening.
Implementation and Evaluation of a Novel Colorectal Cancer Decision Aid Using a Centralized Delivery Strategy. [2019]Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States; however, CRC screening reduces both incidence and mortality rates. Patient decision aids (DAs) are an evidence-based strategy to support patients making health-related decisions. CRC screening DAs can be unsuccessful due to provider preferences for colonoscopy and lack of effective DA implementation strategies within clinical settings.
Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial. [2021]The decision to take up colorectal cancer screening has to be made on informed grounds balancing benefits and harms. Self-administered decision aids can support citizens in making an informed choice. A self-administered web-based decision aid targeting citizens with lower educational attainment has been evaluated within the target population. However, the effectiveness in the general screening population remains unexplored. 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 among previous non-participants in colorectal cancer screening.
Using quality improvement techniques to increase colon cancer screening. [2021]Screening has been shown to be effective and cost-effective in reducing the incidence of, and mortality from, colorectal cancer. Despite its demonstrated efficacy, colon cancer screening remains underused, with fewer than 60% of age-eligible adults reporting being up to date with recommended screening tests. Several factors account for the low rates of utilization, including patient, provider and system-related issues. Several interventions have been shown to be effective in overcoming these barriers, including the use of patient decision aids. Patient decision aids are tools designed to provide information to patients about screening options, help them consider the pros and cons of the alternatives, and assist them to reach a decision consistent with their values. The use of decision aids in clinical practice can increase screening rates by up to 14 percentage points. Mailing the decision aids to patients in advance of office visits appears to be a cost-effective means of implementation.
Randomized controlled trial of a patient decision aid for colorectal cancer screening. [2019]To conduct a pilot test of a decision aid designed to help patients choose among currently recommended colorectal cancer screening programs.
Should a colon cancer screening decision aid include the option of no testing? A comparative trial of two decision aids. [2021]An important question in the development of decision aids about colon cancer (CRC) screening is whether to include an explicit discussion of the option of not being screened. We examined the effect of including or not including an explicit discussion of the option of deciding not to be screened in a CRC screening decision aid on subjective measures of decision aid content; interest in screening; and knowledge.