Colorectal Cancer ScreeningPCCaSONCT01084746
Tailored Interactive Intervention to Increase CRCS
A study testing PC-based tailored intervention and Printed educational materials in people with Colorectal Cancer Screening, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The primary goal of this research project is to conduct a 5-year prospective randomized trial of a theory-based intervention to increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- PC-based tailored intervention and Printed educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,224 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2008
- Phase
- Interventional
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Receive primary care at the KSC Main Campus in Houston, Texas.
- Must have been patients at KSC for at least one year prior to enrollment in the study
- Be 50 to 64 years of age
- Have had CRC or adenomatous polyps
- Must agree to schedule a routine physical examination with their primary care provider and to complete a baseline interview
Who cannot join
- -Have never been screened or be due for CRCS according to the ACS guidelines
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston School of Public Health
Houston, Texas, 77030
About this study
The primary goal of this research project is to conduct a 5-year prospective randomized trial of a theory-based intervention to increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.
Read the detailed description
Specific Aim 1: Identify behavioral, social, and environmental factors associated with CRCS in male and female patients ages 50 to 64 years old in a primary care practice in Houston, Texas.
1.1. Update literature reviews of CRCS adherence. 1.2. Conduct secondary analysis of relevant data from other projects. 1.3. Conduct focus groups with primary care patients to determine their knowledge, attitudes, and beliefs about CRCS and to gather data to use for development of the educational intervention.
Specific Aim 2: Develop a personal computer (PC)-based tailored interactive intervention based on the transtheoretical (stages of change) model to increase CRCS in accordance with American Cancer Society (ACS) CRCS guidelines.
Specific Aim 3: Evaluate the effectiveness of the PC-based tailored interactive intervention for increasing CRCS through a randomized controlled trial.
Specific Aim 4: Analyze the relationship between a number of predictor variables and CRCS completion in order to develop a more complete conceptual framework for understanding screening adherence.
Specific Aim 5: Conduct a cost-effectiveness analysis of the PC-based tailored interactive intervention for increasing CRCS in a primary care setting.
- Conditions
- Colorectal Cancer Screening
- Being tested
- PC-based tailored intervention, Printed educational materials
- Keywords
- Colorectal Cancer Screening, Computer Interactive Intervention, Predictors, Cost Effective Analysis, Transtheoretical Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-based tailored interventionBehavioural
Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.
Printed educational materialsBehavioural
Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.
| Study group | Role | What they receive |
|---|---|---|
| PC-based tailored intervention | Active comparator | Not described Receives: Behavioral: PC-based tailored intervention |
| Printed educational materials | Active comparator | Not described Receives: Behavioral: Printed educational materials |
| No patient intervention | No intervention | Patients will not receive a patient-directed intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.
6, 12, and 24 months post intervention, medical charts were reviewed to validate self-reported CRCS behavior.
Measured: 6months, 12months, 24 months
Secondary outcomes (1)
Secondary goals are to increase understanding of factors that predict completion of CRCS and to assess the cost-effectiveness of the intervention.
Survey data were collected at 6,12,and 24 months.
Measured: 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,224 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sally Vernon, The University of Texas Health Science Center, Houston
- Investigators
- Sally W Vernon, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084746
- Sponsor's protocol ID
- HSC-SPH-01-084
- Other IDs
- R01CA097263-05
- Acronym
- PCCaSO
- Status last verified
- May 2018
- First submitted
- 9 Mar 2010
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McQueen A, Tiro JA, Vernon SW. Construct validity and invariance of four factors associated with colorectal cancer screening across gender, race, and prior screening. Cancer Epidemiol Biomarkers Prev. 2008 Sep;17(9):2231-7. doi: 10.1158/1055-9965.EPI-08-0176.
PubMed 18768488Greisinger A, Hawley ST, Bettencourt JL, Perz CA, Vernon SW. Primary care patients' understanding of colorectal cancer screening. Cancer Detect Prev. 2006;30(1):67-74. doi: 10.1016/j.cdp.2005.10.001. Epub 2006 Feb 2.
PubMed 16458449Lairson DR, Chang YC, Bettencourt JL, Vernon SW, Greisinger A. Estimating development cost for a tailored interactive computer program to enhance colorectal cancer screening compliance. J Am Med Inform Assoc. 2006 Sep-Oct;13(5):476-84. doi: 10.1197/jamia.M2067. Epub 2006 Jun 23.
PubMed 16799126
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Interactive Intervention to Increase CRCS
- ClinicalTrials.gov ID
- NCT01084746
- Acronym / sponsor ID
- PCCaSO / HSC-SPH-01-084
- Conditions
- Colorectal Cancer Screening
- Keywords
- Colorectal Cancer Screening, Computer Interactive Intervention, Predictors, Cost Effective Analysis, Transtheoretical Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,224 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Mar 2010 (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.
The primary goal of this research project is to conduct a 5-year prospective randomized trial of a theory-based intervention to increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.
Detailed description
Specific Aim 1: Identify behavioral, social, and environmental factors associated with CRCS in male and female patients ages 50 to 64 years old in a primary care practice in Houston, Texas.
1.1. Update literature reviews of CRCS adherence. 1.2. Conduct secondary analysis of relevant data from other projects. 1.3. Conduct focus groups with primary care patients to determine their knowledge, attitudes, and beliefs about CRCS and to gather data to use for development of the educational intervention.
Specific Aim 2: Develop a personal computer (PC)-based tailored interactive intervention based on the transtheoretical (stages of change) model to increase CRCS in accordance with American Cancer Society (ACS) CRCS guidelines.
Specific Aim 3: Evaluate the effectiveness of the PC-based tailored interactive intervention for increasing CRCS through a randomized controlled trial.
Specific Aim 4: Analyze the relationship between a number of predictor variables and CRCS completion in order to develop a more complete conceptual framework for understanding screening adherence.
Specific Aim 5: Conduct a cost-effectiveness analysis of the PC-based tailored interactive intervention for increasing CRCS in a primary care setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PC-based tailored intervention | Active comparator | Behavioral: PC-based tailored intervention |
| Printed educational materials | Active comparator | Behavioral: Printed educational materials |
| No patient intervention | No intervention | –Patients will not receive a patient-directed intervention. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Receive primary care at the KSC Main Campus in Houston, Texas.
- Must have been patients at KSC for at least one year prior to enrollment in the study
- Be 50 to 64 years of age
- Have had CRC or adenomatous polyps
- Must agree to schedule a routine physical examination with their primary care provider and to complete a baseline interview
Key exclusion criteria (1 listed)
- -Have never been screened or be due for CRCS according to the ACS guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC-based tailored interventionPatients will receive a tailored interactive PC-based intervention at a freestanding kiosk. | Behavioural | PC-based tailored intervention |
| Printed educational materialsPatients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment. | Behavioural | Printed educational materials |
Primary outcome
Increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.
Time frame: 6months, 12months, 24 months
6, 12, and 24 months post intervention, medical charts were reviewed to validate self-reported CRCS behavior.
1 secondary outcome
Secondary goals are to increase understanding of factors that predict completion of CRCS and to assess the cost-effectiveness of the intervention.
Time frame: 6 months, 12 months, 24 months
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 11 May 2018.
- Results publication: PubMed 18768488McQueen A, Tiro JA, Vernon SW. Construct validity and invariance of four factors associated with colorectal cancer screening across gender, race, and prior screening. Cancer Epidemiol Biomarkers Prev. 2008 Sep;17(9):2231-7. doi: 10.1158/1055-9965.EPI-08-0176.
- Results publication: PubMed 16458449Greisinger A, Hawley ST, Bettencourt JL, Perz CA, Vernon SW. Primary care patients' understanding of colorectal cancer screening. Cancer Detect Prev. 2006;30(1):67-74. doi: 10.1016/j.cdp.2005.10.001. Epub 2006 Feb 2.
- Results publication: PubMed 16799126Lairson DR, Chang YC, Bettencourt JL, Vernon SW, Greisinger A. Estimating development cost for a tailored interactive computer program to enhance colorectal cancer screening compliance. J Am Med Inform Assoc. 2006 Sep-Oct;13(5):476-84. doi: 10.1197/jamia.M2067. Epub 2006 Jun 23.
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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.
Sally W Vernon, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC-based tailored intervention and Printed educational materials in people with Colorectal Cancer Screening, run by The University of Texas Health Science Center, Houston 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 5 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 11 May 2018. 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?
Increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old. (time frame: 6months, 12months, 24 months). 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 NCT01084746, which also lists 3 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 11 May 2018.