Preventing Early-Onset Colorectal Cancer in the VA
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-49
SponsorVA Office of Research and Development
About this trial
Colorectal cancer is a leading cause of cancer death among Veterans. The starting age for colorectal cancer screening has been lowered from 50 to 45 years in response to the rising incidence of early-onset colorectal cancer (EOCRC), but how to best engage younger Veterans in screening is unclear. The investigators will 1) develop and validate a novel risk score for EOCRC derived from the VA electronic health record data, 2) conduct a multilevel screening intervention that targets individuals aged 45-49 years and informs high-risk individuals and their providers about their risk status for EOCRC, and 3) determine barriers and facilitators to implementing the intervention using a qualitative process evaluation. Aim 2 is the focus of the trial. The overall goal of this study is to create and test a risk stratification approach to prevent EOCRC, which may be especially useful for younger individuals who are less likely to participate in preventive care.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 45-49 years at screening
Disqualifiers
Up-to-date with colorectal cancer (CRC) screening based on the USPSTF guideline (e.g., colonoscopy within the past 10 years or FIT within the past year)
Prior colorectal cancer (CRC) diagnosis
Prior total colectomy
Limited life expectancy (defined as terminal illness, hospice enrollment, or documented life expectancy <6 months on the medical problem list or a health factor in the electronic health record (EHR)
Trial design
Design model
Factorial
Treatments tested in this trial
Patient intervention
BehavioralPatient intervention has 2 components. 1) The investigators will send patients a letter that promotes screening and contains targeted messages based on the individual's demographic characteristics. 2) Study staff who is trained in patient navigation will call each patient up to 3 times to confirm receipt of the letter and conduct one-on-one education about screening using a standardized script.
PCP intervention
BehavioralPCP intervention has 2 components. 1) PCPs of patients who are randomized to this group will receive an initial email that provides a list of all patients assigned to the PCP who are randomized to the PCP intervention. PCPs will be specifically informed which patients are high-risk. The email will also include a personal report card with the percentage of patients assigned to the provider who are up-to-date with CRC screening in two age groups: 45-49 years and 50-75 years. Subsequently, PCPs will receive weekly emails with a list of patients randomized to the PCP intervention who are scheduled for a clinic visit with them. 2) The investigators will modify the national colorectal cancer screening reminder locally so that participants who are randomized to this intervention and are calculated to be at high risk will be identified as such.
Treatment groups
536 Participants
are divided into 4 treatment groupsGroup A: Patient interventionExperimental treatment 1 intervention
Group B: Primary care provider (PCP) interventionExperimental treatment 1 intervention
Group C: CombinedExperimental treatment 2 interventions
Group D: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Screening participation rate in groups that received vs. did not receive the patient intervention
For the patient intervention analysis, the investigators will compare the patient and combined arms vs. the PCP and control arms. Completion of FIT, colonoscopy, and any other USPSTF-recommended screening test will be considered to meet the outcome.
Time frame
6 months2
Screening participation rate in groups that received vs. did not receive the PCP intervention
For the PCP intervention analysis, the investigators will compare the PCP and combined arms vs. the patient and control arms. Completion of FIT, colonoscopy, and any other USPSTF-recommended screening test will be considered to meet the outcome.
Time frame
6 monthsSecondary outcomes
1
Screening participation rate in high-risk vs. non-high-risk individuals
Of the 536 individuals the investigators plan to enroll in the trial, 536\*(3/4)=402 will be randomized to one of the three intervention arms. The investigators will compare high- vs. non-high-risk individuals in the intervention arms (n=201 in each arm).
Time frame
6 monthsOther outcomes
1
Screening participation rate in individual groups
The investigators will compare screening uptake a) in the combined patient/PCP intervention arm vs. the single-intervention arm with higher uptake and b) in the single-intervention arm with lower uptake vs. the control arm
Time frame
6 months2
Screening participation rate in Black vs. non-Black individuals
The investigators will compare screening uptake in the three intervention arms for Black vs. non-Black individuals.
Time frame
6 months3
Shared decision making in different intervention groups
The investigators will compare shared decision-making (SDM)-measured by the SDM Process scale-in arms that received a) the patient intervention and b) the PCP intervention.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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