Survey of ColoRectal Cancer Education and Environment Needs

Colorectal Neoplasms Clinical Trial

— SCREEN  

Official title:

Assessing and Addressing Patient Colorectal Cancer Screening Barriers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229554
• Other study ID #: IIR 04-042
• Status: Completed
• Phase: N/A
• First received: September 27, 2005
• Last updated: April 6, 2015
• Start date: March 2006
• Est. completion date: March 2008

Study information

• Verified date: January 2009
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Despite strong evidence for the effectiveness and cost-effectiveness of a variety of colorectal cancer (CRC) screening methods for reducing CRC mortality, current CRC screening rates fall far below the levels needed to significantly impact CRC mortality. Unfortunately, however, the existing literature on patient CRC screening behavior does not yet provide a sufficient evidence base for making sound recommendations regarding how to most effectively improve upon these rates in the VA. This study will inform future CRC screening promotion efforts and make important scientific contributions to existing literature by: (a) delineating the relative contribution of patient cognitive, environmental and background factors to CRC screening behavior using a multi-level, theory driven analysis approach on a nationally representative sample, and (b) identifying the determinants of variation in CRC screening behavior across vulnerable population subgroups.

Description:

Background / Rationale:

Despite strong evidence for the effectiveness and cost-effectiveness of a variety of colorectal cancer (CRC) screening methods for reducing CRC mortality, current CRC screening rates fall far below the levels needed to significantly impact CRC mortality. Unfortunately, however, the existing literature on patient CRC screening behavior does not yet provide a sufficient evidence base for making sound recommendations regarding how to most effectively improve upon these rates in the VA. This study will inform future CRC screening promotion efforts and make important scientific contributions to existing literature by: (a) delineating the relative contribution of patient cognitive, environmental and background factors to CRC screening behavior using a multi-level, theory driven analysis approach on a nationally representative sample, and (b) identifying the determinants of variation in CRC screening behavior across vulnerable population subgroups.

Objective(s):

The overall goal of this study was to address significant gaps in the existing evidence base in order to inform the development of effective patient-directed interventions to increase CRC screening among veterans age 50 and older. This was accomplished by using data collected from a mailed patient survey and theory-based analysis approaches to uncover key barriers to screening adherence and to identify fruitful intervention approaches for modifying them. The specific primary objectives of this study were to: (1) Estimate the relative effect of patient cognitive (knowledge, attitudes, and self-efficacy), environmental (social network and medical care characteristics), and background (demographics, health status, prior screening experiences) factors on CRC screening behavior; (2) Identify factors that contribute to any disparities in CRC screening behavior by race/ethnicity or other patient characteristics; (3) Identify from these analyses: (a) priority population subgroups to target in future interventions (i.e., those at the greatest risk of failing to be screened), and (b) priority factors to target in future interventions (i.e., those that are not only strongly associated with CRC screening but also prevalent in the target population and amenable to intervention, as well as those that are most likely to ameliorate race and other disparities). Secondary objectives included: (1) assessing patient values and preferences regarding the various CRC screening modality options, (2) estimating stage of readiness to adopt CRC screening in the study population, and (3) validating measures of CRC knowledge and self-reported screening behavior.

Methods:

This is an observational study based on a nationally representative, cross-sectional mailed survey of 3,744 male and female veterans age 50-75 who have had one or more primary care visits at a VA Medical facility in the past two years. The survey sample was drawn using a two stage procedure where we first randomly select 24 VA facilities stratified by size and racial mix and then select a simple random sample of 156 eligible veterans from each sampled facility. Prior to the national survey, a pilot survey was conducted with the purpose of refining both the study instruments and the study protocol. The sample consisted of 900 randomly selected veterans from the Minneapolis VA Medical Center meeting the same sampling eligibility criteria used for the national mailed survey. The mailed patient questionnaire, made up primarily of previously validated measures, included measures of self-reported CRC screening behavior; patient demographic, health, social network and medical care characteristics; CRC screening knowledge, attitudes, social norms and self-efficacy; and attitudes toward medical care. Additional measures of organizational-level CRC screening practices from a recently completed VA facility survey were linked to the patient survey.The primary outcome is whether the patient is currently compliant with CRC screening guidelines (i.e., received either a fecal occult blood test in the past year, a sigmoidoscopy or double contrast barium enema in the past five years, or a colonoscopy in the past ten years). The primary analyses tested (using logistic regression and a multi-level, structural equation modeling approach) specific hypotheses about the association between this measure and patient background, cognitive and environmental factors and their interactions. Additional analyses conducted include a multinomial logistic regression to assess patient screening mode preferences and their determinants, and logistic and multinomial logistics regression analyses with interactions to determine whether and why any observed patterns in CRC screening behavior vary by race.

Status:

Completed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4644
• Est. completion date: March 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

Study subjects must be a male or female veteran who has had one or more primary care visits at a VHA medical center in the past 2 years and is between the age of 50 and 75.

Exclusion Criteria:

Study subjects cannot be a VHA employee, deceased, have a colorectal cancer diagnosis, be enrolled in VA adult day care or nursing home, or have dementia.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Mass Screening
• Patient Compliance

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (10)

Burgess DJ, Grill J, Noorbaloochi S, Griffin JM, Ricards J, van Ryn M, Partin MR. The effect of perceived racial discrimination on bodily pain among older African American men. Pain Med. 2009 Nov;10(8):1341-52. doi: 10.1111/j.1526-4637.2009.00742.x. — View Citation

Burgess DJ, Powell AA, Griffin JM, Partin MR. Race and the validity of self-reported cancer screening behaviors: development of a conceptual model. Prev Med. 2009 Feb;48(2):99-107. doi: 10.1016/j.ypmed.2008.11.014. Epub 2008 Dec 11. Review. — View Citation

Burgess DJ, van Ryn M, Grill J, Noorbaloochi S, Griffin JM, Ricards J, Vernon SW, Fisher DA, Partin MR. Presence and correlates of racial disparities in adherence to colorectal cancer screening guidelines. J Gen Intern Med. 2011 Mar;26(3):251-8. doi: 10.1 — View Citation

Friedemann-Sánchez G, Griffin JM, Partin MR. Gender differences in colorectal cancer screening barriers and information needs. Health Expect. 2007 Jun;10(2):148-60. — View Citation

Griffin JM, Burgess D, Vernon SW, Friedemann-Sanchez G, Powell A, van Ryn M, Halek K, Noorbaloochi S, Grill J, Bloomfield H, Partin M. Are gender differences in colorectal cancer screening rates due to differences in self-reporting? Prev Med. 2009 Nov;49( — View Citation

Kodl MM, Powell AA, Noorbaloochi S, Grill JP, Bangerter AK, Partin MR. Mental health, frequency of healthcare visits, and colorectal cancer screening. Med Care. 2010 Oct;48(10):934-9. doi: 10.1097/MLR.0b013e3181e57901. — View Citation

Partin MR, Burgess DJ, Halek K, Grill J, Vernon SW, Fisher DA, Griffin JM, Murdoch M. Randomized trial showed requesting medical records with a survey produced a more representative sample than requesting separately. J Clin Epidemiol. 2008 Oct;61(10):1028 — View Citation

Partin MR, Grill J, Noorbaloochi S, Powell AA, Burgess DJ, Vernon SW, Halek K, Griffin JM, van Ryn M, Fisher DA. Validation of self-reported colorectal cancer screening behavior from a mixed-mode survey of veterans. Cancer Epidemiol Biomarkers Prev. 2008 — View Citation

Partin MR, Noorbaloochi S, Grill J, Burgess DJ, van Ryn M, Fisher DA, Griffin JM, Powell AA, Halek K, Bangerter A, Vernon SW. The interrelationships between and contributions of background, cognitive, and environmental factors to colorectal cancer screeni — View Citation

Powell AA, Burgess DJ, Vernon SW, Griffin JM, Grill JP, Noorbaloochi S, Partin MR. Colorectal cancer screening mode preferences among US veterans. Prev Med. 2009 Nov;49(5):442-8. doi: 10.1016/j.ypmed.2009.09.002. Epub 2009 Sep 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colorectal cancer screening compliance		self-report or medical records documentation of either a fecal occult blood test (FOBT) in the past 15 months, a sigmoidoscopy or double contrast barium enema in the past 5.5 years, or a colonoscopy in the past 11 years	No