Clinical trial NCT02368236: Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)
Official title: Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Colonic Neoplasms
Keywords: Early Detection of Cancer
Intervention Studies
Randomized Controlled Trial
Colorectal Neoplasms
Colonic Neoplasms
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-02-23
Enrollment: 1012
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study will adapt and test a touch-screen computer program to evaluate cancer risk and provide patient-tailored recommendations for appropriate risk-based testing. This individually tailored intervention delivered right at the point of primary care and just prior to the office visit, can be a helpful and non-obstructive adjunct to clinical care.

The primary aim of this project is to test whether a tailored intervention promoting risk-appropriate cancer testing results increases participation compared with a simple non-tailored reminder or no reminder. The trial is designed to determine the extent to which the Cancer Risk Intake System (CRIS) facilitates (1) participation in risk-appropriate colorectal cancer testing, as documented by electronic medical record audit; (2) patient receipt of risk-appropriate colorectal cancer testing recommendations from their physicians, as documented by electronic medical record audit; and (3) changes in patients' intent to participate in risk-appropriate colorectal cancer testing, as documented by patient report.

The Family and Community Medicine and General Internal Medicine clinic databases will be used to identify potentially eligible patients with upcoming scheduled appointments. Because physicians will be the unit of random assignment, patients will be coded before study invitation as potential participants in the intervention or the comparison group. A random sample of eligible intervention and comparison group patients will be selected for contact. Identified patients will be mailed letters from the practices and signed by their physicians requesting their participation. The letters will describe a "study of beliefs and practices about cancer prevention and early detection" and will provide a toll-free number to refuse contact. One week after the mailing, patients who have not called to refuse contact will be called by study staff to explain the study, verify eligibility and, if the patient agrees, to arrange an in-person meeting at the clinic 30 minutes prior to their appointment. These calls will be made by trained research assistants who will follow standard calling protocols. After consent, participants will complete the computerized data collection (CRIS) immediately prior to a scheduled primary-care appointment. Intervention group patients and their physicians will receive a printout recommending risk-appropriate colorectal testing and ways to overcome perceived barriers to testing. A member of the research team will hand the patient his or her printout and will deliver the other printout to the physician. Comparison group patients and physicians will receive non-tailored printouts that are simple reminders about testing.

The investigators will also establish a true no-contact control by conducting a retrospective chart review for randomly selected patients who did not receive an invitation to participate in the study. This no-contact control will establish a baseline screening rate. The investigators will then conduct analysis with the comparison and intervention group to see if individuals who participate in CRIS have a higher screening rate for colorectal cancer compared to the non-contact group. These additional data will help us better assess study Aims 1 and 2.


Eligibility criteria: Inclusion Criteria:

* Patients will be considered eligible if they are age 25-75 and have an upcoming appointment and have not had a colonoscopy during the previous 5 years.
* Eligible patients ages 25-49 must also have a family history of colorectal cancer or personal history of inflammatory bowel disease or adenomatous polyps.
* Pregnant women will be included.

Exclusion Criteria:

* Adults younger than age 25 will be excluded because colorectal testing would be inappropriate for the vast majority of patients this young. The benefit of discerning patients in this age group for whom testing would be appropriate would be outweighed by the amount of labor and cost necessary to identify them.
* Patients between ages of 25 and 75 will be excluded if they have had colorectal cancer, a colonoscopy in the last five years, do not give informed consent, do not have access to a telephone, or have severely impaired hearing or speech.
* In addition, patients between ages 25 and 49 will be excluded unless they have a close relative diagnosed with Colon or Rectal Cancer before the age of \[pts age + 11\] or they've had a colon polyp or inflammatory bowel disease.
* Patients who do not speak or read English will not be eligible for participation in the main study. In years 3 and 4, patients whose main language is Spanish will be included for participation in cognitive interviews and a pilot test to ensure the S-CRIS is culturally appropriate, conceptually equivalent, and usable for the diverse Spanish-speaking primary-care population.
* Patients who are cognitively impaired will be excluded from all parts of the study.

Primary outcomes:
measure: Participation in risk-appropriate colorectal cancer testing (i.e., participation in any CRIS-recommended test based on patients' risk factors).
timeFrame: 12 month post baseline
Secondary outcomes:
measure: Participation in any type of colorectal cancer testing.
timeFrame: 12 month post baseline
measure: Testing difference in receipt of any type of colorectal cancer testing.
timeFrame: 12 month post baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Celette S Skinner, PhD
role: PRINCIPAL_INVESTIGATOR
References: