Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)

Study ID
STU 112010-132

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System
  • Parkland Health & Hospital System
  • Parkland Health & Hospital System
  • Parkland Health & Hospital System
  • Parkland Health & Hospital System
  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services
  • UT Southwestern Ambulatory Services
  • UT Southwestern Ambulatory Services
  • UT Southwestern Ambulatory Services
  • UT Southwestern Ambulatory Services
  • UT Southwestern Ambulatory Services
  • UT Southwestern-Other
  • UT Southwestern-Other
  • UT Southwestern-Other
  • UT Southwestern-Other
  • UT Southwestern-Other
  • UT Southwestern-Other

Contact
Wendy Bishop
214-648-6489
wendy.bishop@utsouthwestern.edu

Principal Investigator
Celette Skinner

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.
Screening: 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.

Procedures and Evaluations during the Research: 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. For example, individuals will be tried at different times during different days of the week, with no more than 2 attempts during each calling period (e.g., no more than two attempts on a Tues evening). If RAs reach an answering machine, they will leave a standardized message; no more than 1 message per week and no more than 2 messages overall will be left for any patient. After consent, all participants will complete the computerized data collection (CRIS) immediately prior to a scheduled primary-care appointment which will generate two tailored printouts ? one for the patient and one for the physician. A member of the research team will hand the patient his or her printout and will deliver the other printout to the physician.
Patients seen in participating clinics will be assigned, by random assignment of the physician each is seeing, to the tailored interventions group or to a comparison group receiving non-tailored print outs. Intervention group patients and their physicians will receive a printout recommending risk-appropriate colorectal testing and ways to overcome perceived barriers to testing. Comparison group patients and physicians will receive non-tailored printouts that are simple reminders about testing.
We will also establish a true no-contact control by conducting a retrospective chart review for 325 randomly selected patients who did not receive an invitation to participate in the study. This no-contact control will establish a baseline screening rate. We 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.

Participant Eligibility

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