Clinical Trials Logo

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.


Clinical Trial 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 ;


Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT00229554
Study type Observational
Source VA Office of Research and Development
Contact
Status Completed
Phase N/A
Start date March 2006
Completion date March 2008

See also
  Status Clinical Trial Phase
Recruiting NCT04552093 - Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT) Phase 2/Phase 3
Completed NCT04192565 - A Prospective Investigation of the ColubrisMX ELS System N/A
Completed NCT05178745 - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Recruiting NCT03561350 - Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Recruiting NCT06128798 - Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery. N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Completed NCT03631407 - Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046) Phase 2
Withdrawn NCT04192929 - Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02889679 - Underwater Resection of Non-pedunculated Colorectal Lesions N/A
Terminated NCT02842580 - De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT02564835 - Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer N/A
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Completed NCT02149108 - Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1) Phase 3
Completed NCT02599103 - The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects N/A
Completed NCT01669109 - Hatha Yoga for Patients With Colorectal Cancer N/A
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Recruiting NCT01428752 - Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer N/A
Completed NCT01978717 - General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer N/A
Completed NCT01877018 - Colorectal Cancer Screening in Primary Care N/A