Colorectal NeoplasmsSCREENNCT00229554
Survey of ColoRectal Cancer Education and Environment Needs
An observational study of Colorectal Neoplasms and Mass Screening, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Mass Screening, Patient Compliance
- How many people
- 4,644 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
Official title: Assessing and Addressing Patient Colorectal Cancer Screening Barriers
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.
Read the detailed 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
- Conditions
- Colorectal Neoplasms, Mass Screening, Patient Compliance
- Keywords
- health surveys, questionnaires
- Medical subject headings
- Colorectal Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
colorectal cancer screening compliance
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startMar 2006
- Primary completionMay 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 4,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Melissa R. Partin, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229554
- Sponsor's protocol ID
- IIR 04-042
- Acronym
- SCREEN
- Status last verified
- Jan 2009
- First submitted
- 27 Sep 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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 Apr;17(4):768-76. doi: 10.1158/1055-9965.EPI-07-0759. Epub 2008 Apr 1.
PubMed 18381474Burgess 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.
PubMed 19118570Partin 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):1028-35. doi: 10.1016/j.jclinepi.2007.11.015. Epub 2008 Jun 11.
PubMed 18550333Friedemann-Sanchez G, Griffin JM, Partin MR. Gender differences in colorectal cancer screening barriers and information needs. Health Expect. 2007 Jun;10(2):148-60. doi: 10.1111/j.1369-7625.2006.00430.x.
PubMed 17524008Burgess 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: 10.1007/s11606-010-1575-7. Epub 2010 Nov 18.
PubMed 21088920Kodl 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.
PubMed 20706162Partin 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 screening adherence. Cancer Causes Control. 2010 Sep;21(9):1357-68. doi: 10.1007/s10552-010-9563-0. Epub 2010 Apr 24.
PubMed 20419343Burgess 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.
PubMed 20021596Powell 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.
PubMed 19747502Griffin 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(5):436-41. doi: 10.1016/j.ypmed.2009.09.013. Epub 2009 Sep 16.
PubMed 19765609
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing and Addressing Patient Colorectal Cancer Screening Barriers
- ClinicalTrials.gov ID
- NCT00229554
- Acronym / sponsor ID
- SCREEN / IIR 04-042
- Conditions
- Colorectal Neoplasms, Mass Screening, Patient Compliance
- Keywords
- health surveys, questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,644 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care patients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
colorectal cancer screening compliance
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 18381474Partin 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 Apr;17(4):768-76. doi: 10.1158/1055-9965.EPI-07-0759. Epub 2008 Apr 1.
- Results publication: PubMed 19118570Burgess 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.
- Results publication: PubMed 18550333Partin 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):1028-35. doi: 10.1016/j.jclinepi.2007.11.015. Epub 2008 Jun 11.
- Results publication: PubMed 17524008Friedemann-Sanchez G, Griffin JM, Partin MR. Gender differences in colorectal cancer screening barriers and information needs. Health Expect. 2007 Jun;10(2):148-60. doi: 10.1111/j.1369-7625.2006.00430.x.
- Results publication: PubMed 21088920Burgess 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: 10.1007/s11606-010-1575-7. Epub 2010 Nov 18.
- Results publication: PubMed 20706162Kodl 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.
- Results publication: PubMed 20419343Partin 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 screening adherence. Cancer Causes Control. 2010 Sep;21(9):1357-68. doi: 10.1007/s10552-010-9563-0. Epub 2010 Apr 24.
- Results publication: PubMed 20021596Burgess 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.
- Results publication: PubMed 19747502Powell 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.
- Results publication: PubMed 19765609Griffin 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(5):436-41. doi: 10.1016/j.ypmed.2009.09.013. Epub 2009 Sep 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa R. Partin, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Mass Screening, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colorectal cancer screening compliance (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00229554, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.