Colorectal NeoplasmsNCT02368236
Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)
A study testing Tailored Printout in people with Colorectal Neoplasms and Colonic Neoplasms, run by University of Texas Southwestern Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Colonic Neoplasms
- What is being tested?
- Tailored Printout
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Nov 2012
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be considered eligible if they are age 25-75 and have an upcoming appointment and have not had a colonoscopy during the previous 5 years.
- Eligible patients ages 25-49 must also have a family history of colorectal cancer or personal history of inflammatory bowel disease or adenomatous polyps.
- Pregnant women will be included.
Who cannot join
- Adults younger than age 25 will be excluded because colorectal testing would be inappropriate for the vast majority of patients this young. The benefit of discerning patients in this age group for whom testing would be appropriate would be outweighed by the amount of labor and cost necessary to identify them.
- Patients between ages of 25 and 75 will be excluded if they have had colorectal cancer, a colonoscopy in the last five years, do not give informed consent, do not have access to a telephone, or have severely impaired hearing or speech.
- In addition, patients between ages 25 and 49 will be excluded unless they have a close relative diagnosed with Colon or Rectal Cancer before the age of [pts age + 11] or they've had a colon polyp or inflammatory bowel disease.
- Patients who do not speak or read English will not be eligible for participation in the main study. In years 3 and 4, patients whose main language is Spanish will be included for participation in cognitive interviews and a pilot test to ensure the S-CRIS is culturally appropriate, conceptually equivalent, and usable for the diverse Spanish-speaking primary-care population.
- Patients who are cognitively impaired will be excluded from all parts of the study.
About this study
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.
The primary aim of this project is to test whether a tailored intervention promoting risk-appropriate cancer testing results increases participation compared with a simple non-tailored reminder or no reminder. The trial is designed to determine the extent to which the Cancer Risk Intake System (CRIS) facilitates (1) participation in risk-appropriate colorectal cancer testing, as documented by electronic medical record audit; (2) patient receipt of risk-appropriate colorectal cancer testing recommendations from their physicians, as documented by electronic medical record audit; and (3) changes in patients' intent to participate in risk-appropriate colorectal cancer testing, as documented by patient report.
Read more
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. 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. After consent, participants will complete the computerized data collection (CRIS) immediately prior to a scheduled primary-care appointment. Intervention group patients and their physicians will receive a printout recommending risk-appropriate colorectal testing and ways to overcome perceived barriers to testing. A member of the research team will hand the patient his or her printout and will deliver the other printout to the physician. Comparison group patients and physicians will receive non-tailored printouts that are simple reminders about testing.
The investigators will also establish a true no-contact control by conducting a retrospective chart review for randomly selected patients who did not receive an invitation to participate in the study. This no-contact control will establish a baseline screening rate. The investigators 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.
- Conditions
- Colorectal Neoplasms, Colonic Neoplasms
- Being tested
- Tailored Printout
- Keywords
- Early Detection of Cancer, Intervention Studies, Randomized Controlled Trial, Colorectal Neoplasms, Colonic Neoplasms
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored PrintoutBehavioural
The Cancer Risk Intake System (CRIS) is a tablet-based program through which patients answer detailed questions about their colorectal cancer risk prior to an appointment. Tailoring algorithms in CRIS generate printed information for patients and their physicians summarizing their risk factors and matching them with guideline-based screening options.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Other | Patients randomized to the intervention group will use CRIS. Then intervention group patients and their physicians will receive a tailored printout generated by the CRIS recommending risk-appropriate colorectal testing and ways to overcome perceived barriers to testing. A member of the research team will hand the patient a printout and will deliver the other printout to the physician. Receives: Behavioral: Tailored Printout |
| Comparison Group | No intervention | Patients randomized to the comparison group will use CRIS, but receive a non-tailored standard information about multiple types of cancer screening (e.g., content from an American Cancer Society cancer screening brochure) while physicians receive standard electronic chart prompts indicating the patients were age-eligible but not currently adherent for colorectal cancer screening. |
| True No-contact Control Group | No intervention | A screening baseline for the true no-contact group will be established by conducting a retrospective chart review for patients who did not receive an invitation to participate in this study. The same randomization procedure will be used as the comparison and intervention groups. The purpose is to 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in risk-appropriate colorectal cancer testing (i.e., participation in any CRIS-recommended test based on patients' risk factors).
Mixed-effects logistic regression model. Group assignment = main independent variable. Physician = random cluster effect.
Binary outcome values:
- Participation in any risk-appropriate CRIS-recommended test.
- Either no testing or participation in a non-recommended test (e.g., stool-based test for an individual whose risk profile indicated need for colonoscopy).
For patients assigned to the:
- Intervention group (i.e., tailored printout).
- Comparison group (i.e., non-tailored printout).
Measured: 12 month post baseline
Secondary outcomes (2)
Participation in any type of colorectal cancer testing.
Mixed-effects logistic regression model. Group assignment = main independent variable. Physician = random cluster effect.
Binary outcome values:
- Participation in any testing.
- No participation in testing within 12 months.
For patients assigned to the:
- Intervention group (i.e., tailored printout).
- Comparison group (i.e., non-tailored printout).
Measured: 12 month post baseline
Testing difference in receipt of any type of colorectal cancer testing.
Mixed-effects logistic regression model. Group assignment = main independent variable. Physician = random cluster effect. Age and gender = covariates.
Difference between patients assigned to:
- Use CRIS (i.e., intervention group = tailored printout and comparison group = non-tailored printout).
- True no-contact control group.
Measured: 12 month post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startDec 2008
- Primary completionFeb 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Celette S Skinner, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368236
- Sponsor's protocol ID
- 112010-132
- Other IDs
- R01CA122330
- Status last verified
- Jul 2018
- First submitted
- 28 Jan 2015
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)
- ClinicalTrials.gov ID
- NCT02368236
- Acronym / sponsor ID
- 112010-132
- Conditions
- Colorectal Neoplasms, Colonic Neoplasms
- Keywords
- Early Detection of Cancer, Intervention Studies, Randomized Controlled Trial, Colorectal Neoplasms, Colonic Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Feb 2015 (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.
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.
The primary aim of this project is to test whether a tailored intervention promoting risk-appropriate cancer testing results increases participation compared with a simple non-tailored reminder or no reminder. The trial is designed to determine the extent to which the Cancer Risk Intake System (CRIS) facilitates (1) participation in risk-appropriate colorectal cancer testing, as documented by electronic medical record audit; (2) patient receipt of risk-appropriate colorectal cancer testing recommendations from their physicians, as documented by electronic medical record audit; and (3) changes in patients' intent to participate in risk-appropriate colorectal cancer testing, as documented by patient report.
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. 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. After consent, participants will complete the computerized data collection (CRIS) immediately prior to a scheduled primary-care appointment. Intervention group patients and their physicians will receive a printout recommending risk-appropriate colorectal testing and ways to overcome perceived barriers to testing. A member of the research team will hand the patient his or her printout and will deliver the other printout to the physician. Comparison group patients and physicians will receive non-tailored printouts that are simple reminders about testing.
The investigators will also establish a true no-contact control by conducting a retrospective chart review for randomly selected patients who did not receive an invitation to participate in the study. This no-contact control will establish a baseline screening rate. The investigators 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Behavioral: Tailored PrintoutPatients randomized to the intervention group will use CRIS. Then intervention group patients and their physicians will receive a tailored printout generated by the CRIS recommending risk-appropriate colorectal testing and ways to overcome perceived barriers to testing. A member of the research team will hand the patient a printout and will deliver the other printout to the physician. |
| Comparison Group | No intervention | –Patients randomized to the comparison group will use CRIS, but receive a non-tailored standard information about multiple types of cancer screening (e.g., content from an American Cancer Society cancer screening brochure) while physicians receive standard electronic chart prompts indicating the patients were age-eligible but not currently adherent for colorectal cancer screening. |
| True No-contact Control Group | No intervention | –A screening baseline for the true no-contact group will be established by conducting a retrospective chart review for patients who did not receive an invitation to participate in this study. The same randomization procedure will be used as the comparison and intervention groups. The purpose is to 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients will be considered eligible if they are age 25-75 and have an upcoming appointment and have not had a colonoscopy during the previous 5 years.
- Eligible patients ages 25-49 must also have a family history of colorectal cancer or personal history of inflammatory bowel disease or adenomatous polyps.
- Pregnant women will be included.
Key exclusion criteria (5 listed)
- Adults younger than age 25 will be excluded because colorectal testing would be inappropriate for the vast majority of patients this young. The benefit of discerning patients in this age group for whom testing would be appropriate would be outweighed by the amount of labor and cost necessary to identify them.
- Patients between ages of 25 and 75 will be excluded if they have had colorectal cancer, a colonoscopy in the last five years, do not give informed consent, do not have access to a telephone, or have severely impaired hearing or speech.
- In addition, patients between ages 25 and 49 will be excluded unless they have a close relative diagnosed with Colon or Rectal Cancer before the age of [pts age + 11] or they've had a colon polyp or inflammatory bowel disease.
- Patients who do not speak or read English will not be eligible for participation in the main study. In years 3 and 4, patients whose main language is Spanish will be included for participation in cognitive interviews and a pilot test to ensure the S-CRIS is culturally appropriate, conceptually equivalent, and usable for the diverse Spanish-speaking primary-care population.
- Patients who are cognitively impaired will be excluded from all parts of the study.
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 |
|---|---|---|
| Tailored PrintoutThe Cancer Risk Intake System (CRIS) is a tablet-based program through which patients answer detailed questions about their colorectal cancer risk prior to an appointment. Tailoring algorithms in CRIS generate printed information for patients and their physicians summarizing their risk factors and matching them with guideline-based screening options. | Behavioural | Intervention Group |
Primary outcome
Participation in risk-appropriate colorectal cancer testing (i.e., participation in any CRIS-recommended test based on patients' risk factors).
Time frame: 12 month post baseline
Mixed-effects logistic regression model. Group assignment = main independent variable. Physician = random cluster effect. Binary outcome values: * Participation in any risk-appropriate CRIS-recommended test. * Either no testing or participation in a non-recommended test (e.g., stool-based test for an individual whose risk profile indicated need for colonoscopy). For patients assigned to the: * Intervention group (i.e., tailored printout). * Comparison group (i.e., non-tailored printout).
2 secondary outcomes
Participation in any type of colorectal cancer testing.
Time frame: 12 month post baseline
Testing difference in receipt of any type of colorectal cancer testing.
Time frame: 12 month post baseline
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 30 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Celette S Skinner, PhD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Printout in people with Colorectal Neoplasms and Colonic Neoplasms, run by University of Texas Southwestern Medical Center.
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 3 inclusion and 5 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Participation in risk-appropriate colorectal cancer testing (i.e., participation in any CRIS-recommended test based on patients' risk factors). (time frame: 12 month post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2018.