Colorectal CancerNCT01710215
Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
A study testing FIT Screening Strategy and Colon Screening Strategy in people with Colorectal Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening… Read more about this study
- Who is it for?
- Ages 50 to 64 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FIT Screening Strategy and Colon Screening Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,999 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Males and females
- Age 50-64 years
- Seen one or more times at a Parkland primary care clinic within one year (Index Year)
- Participants in Parkland's medical assistance program for the uninsured (Parkland Health Plus)
- All races and ethnicities
Who cannot join
- Up-to-date with CRC screening, defined by:
- Colonoscopy in the last 10 years
- Sigmoidoscopy in the last 5 years
- Stool blood test (FIT) in the last year
- Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps
- Address or phone number not on file
- Incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health & Hospital System
Dallas, Texas, 75235
About this study
Official title: Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening process continuum. Modeling studies suggest benefits and harms of colonoscopy and stool blood test strategies are similar, but generally assume 100% participation and subsequent clinically appropriate follow up--something never achieved in clinical practice. Comparative effectiveness studies of testing strategies, including comparisons of specific tests and approaches to optimizing effective test use, are necessary. Safety-net health systems care for populations at increased risk for adverse CRC outcomes, such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets must resolve the uncertainty regarding the most effective screening strategy. The investigators will conduct a system-level, randomized comparative effectiveness trial of the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age 50-64 years, who are not up-to-date with CRC screening, served by a large safety net health system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual mailed invitation outreach (including a test kit), and a centralized process to promote participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed invitation outreach, and a centralized process to promote participation and complete clinical follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at primary care visits. The primary measure of benefit will be an outcome measure that summarizes patient-specific effective screening successes. The primary measure of harm will be screening non-participation. The primary measure of cost will be cost per-patient effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care and b) the Colo strategy vs. Usual Care for CRC screening.
- Conditions
- Colorectal Cancer
- Being tested
- FIT Screening Strategy, Colon Screening Strategy
- Keywords
- Colorectal Neoplasms, Colorectal Cancer, Colon Cancer, Mass Screening, Health Services Research, Comparative Effectiveness Research
- 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.
FIT Screening StrategyOther
- Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).
- Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
- Centralized processes to promote guideline-based follow up.
Colon Screening StrategyOther
- Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.
- Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.
- Centralized processes to promote guideline-based follow up.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | * No outreach mailed invitations. * Ordering of colonoscopy or FIT for screening at the discretion of the primary provider. * Follow up of abnormal tests and results reporting to the patient at the discretion of primary and specialty providers. |
| FIT Screening Strategy | Experimental | * Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).
* Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
* Centralized processes to promote guideline-based follow up. Receives: Other: FIT Screening Strategy |
| Colon Screening Strategy | Experimental | * Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.
* Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.
* Centralized processes to promote guideline-based follow up. Receives: Other: Colon Screening Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefit: Proportion of patients achieving one of the effective screening "successes."
The primary benefit measure will be defined by the proportion of patients achieving an effective screening "success" defined as:
- Invited to colonoscopy (i.e. colo), responded to invite, determined to be too sick to scope by phone triage and clinical review
- Screening colo completed, no cancer detected
- Screening colo completed, cancer detected, 1st cancer treatment consultation visit completed
- FIT screening completed, test normal, FIT repeated annually for 2 years
- FIT screening completed, test abnormal, failed phone triage for direct scheduling for colo, and after GI clinic visit, determined to be too sick to scope
- FIT screening completed, test abnormal, failed phone triage and clinical review, GI clinic visit, determined to be scopable, colo completed
- FIT screening completed, test abnormal, colo completed, no cancer detected
- FIT screening completed, test abnormal, colo completed, cancer detected, 1st cancer treatment consultation visit completed
Measured: All outcomes will be adjudicated within 3 years.
Harm: Rate of screening non-participation.
The primary measure of harms will be the rate of non-screening because initial test completion is a basic prerequisite for prevention of adverse CRC outcomes by a screening process. It is a readily measurable, basic quality assessment. Processes associated with high rates of non-screening would be expected to result in poor long term CRC outcomes.
Measured: All outcomes will be adjudicated within 3 years.
Cost: Cost per-patient effectively screened.
The primary measure of costs will be the cost per-patient effectively screened from the health system perspective, with effective screening defined by the proportion of patients achieving an effective screening "success." Follow up time for cost-assessment will start at randomization and end either when a patient reaches an effective screening "success" endpoint, or at the end of the three year-follow up time. This outcome addresses a practical question most health systems will have in assessing our screening strategy: What is the strategy specific cost per-patient effectively screened?
Measured: All outcomes will be adjudicated within 3 years.
Secondary outcomes (8)
Benefit: Number of CRCs, advanced adenomas, and adenomas detected.
Number of CRCs, advanced adenomas, and adenomas detected.
Measured: All outcomes will be adjudicated within 3 years.
Benefit: Number of patients screened.
Number of patients screened, defined by the proportion of patients completing one time FIT or colonoscopy.
Measured: All outcomes will be adjudicated within 3 years.
Harm: Number of CRCs diagnosed based on symptoms/signs rather than screening.
Number of CRCs diagnosed based on symptoms/signs rather than screening.
Measured: All outcomes will be adjudicated within 3 years.
Harm: Ineffective screening.
Not achieving an effective screening "success." See definition of effective screening "successes" above.
Measured: All outcomes will be adjudicated within 3 years.
Harm: Post-colonoscopy bleeding or perforation.
Post-colonoscopy bleeding or perforation.
Measured: All outcomes will be adjudicated within 3 years.
Harm: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.
Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.
Measured: All outcomes will be adjudicated within 3 years.
Cost: Cost per patient screened.
Cost per patient screened.
Measured: All outcomes will be adjudicated within 3 years.
Cost: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.
Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.
Measured: All outcomes will be adjudicated within 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startApr 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Parkland Health and Hospital System
- Responsible party
- Sponsor
- Investigators
- Amit Singal, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710215
- Sponsor's protocol ID
- 102011-069
- Other IDs
- 1U54CA163308-01
- Status last verified
- Apr 2018
- First submitted
- 5 Oct 2012
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Singal AG, Gupta S, Skinner CS, Ahn C, Santini NO, Agrawal D, Mayorga CA, Murphy C, Tiro JA, McCallister K, Sanders JM, Bishop WP, Loewen AC, Halm EA. Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):806-815. doi: 10.1001/jama.2017.11389.
PubMed 28873161
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
- ClinicalTrials.gov ID
- NCT01710215
- Acronym / sponsor ID
- 102011-069
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Neoplasms, Colorectal Cancer, Colon Cancer, Mass Screening, Health Services Research, Comparative Effectiveness Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,999 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Parkland Health and Hospital System
- Study start
- Apr 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Oct 2012 (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.
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening process continuum. Modeling studies suggest benefits and harms of colonoscopy and stool blood test strategies are similar, but generally assume 100% participation and subsequent clinically appropriate follow up--something never achieved in clinical practice. Comparative effectiveness studies of testing strategies, including comparisons of specific tests and approaches to optimizing effective test use, are necessary. Safety-net health systems care for populations at increased risk for adverse CRC outcomes, such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets must resolve the uncertainty regarding the most effective screening strategy. The investigators will conduct a system-level, randomized comparative effectiveness trial of the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age 50-64 years, who are not up-to-date with CRC screening, served by a large safety net health system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual mailed invitation outreach (including a test kit), and a centralized process to promote participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed invitation outreach, and a centralized process to promote participation and complete clinical follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at primary care visits. The primary measure of benefit will be an outcome measure that summarizes patient-specific effective screening successes. The primary measure of harm will be screening non-participation. The primary measure of cost will be cost per-patient effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care and b) the Colo strategy vs. Usual Care for CRC screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –* No outreach mailed invitations. * Ordering of colonoscopy or FIT for screening at the discretion of the primary provider. * Follow up of abnormal tests and results reporting to the patient at the discretion of primary and specialty providers. |
| FIT Screening Strategy | Experimental | Other: FIT Screening Strategy* Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage). * Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion. * Centralized processes to promote guideline-based follow up. |
| Colon Screening Strategy | Experimental | Other: Colon Screening Strategy* Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy. * Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion. * Centralized processes to promote guideline-based follow up. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females
- Age 50-64 years
- Seen one or more times at a Parkland primary care clinic within one year (Index Year)
- Participants in Parkland's medical assistance program for the uninsured (Parkland Health Plus)
- All races and ethnicities
Key exclusion criteria (7 listed)
- Up-to-date with CRC screening, defined by:
- Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps
- Address or phone number not on file
- Incarcerated
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 |
|---|---|---|
| FIT Screening Strategy* Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage). * Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion. * Centralized processes to promote guideline-based follow up. | Other | FIT Screening Strategy |
| Colon Screening Strategy* Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy. * Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion. * Centralized processes to promote guideline-based follow up. | Other | Colon Screening Strategy |
Primary outcome
Benefit: Proportion of patients achieving one of the effective screening "successes."
Time frame: All outcomes will be adjudicated within 3 years.
The primary benefit measure will be defined by the proportion of patients achieving an effective screening "success" defined as: * Invited to colonoscopy (i.e. colo), responded to invite, determined to be too sick to scope by phone triage and clinical review * Screening colo completed, no cancer detected * Screening colo completed, cancer detected, 1st cancer treatment consultation visit completed * FIT screening completed, test normal, FIT repeated annually for 2 years * FIT screening completed, test abnormal, failed phone triage for direct scheduling for colo, and after GI clinic visit, determined to be too sick to scope * FIT screening completed, test abnormal, failed phone triage and clinical review, GI clinic visit, determined to be scopable, colo completed * FIT screening completed, test abnormal, colo completed, no cancer detected * FIT screening completed, test abnormal, colo completed, cancer detected, 1st cancer treatment consultation visit completed
Harm: Rate of screening non-participation.
Time frame: All outcomes will be adjudicated within 3 years.
The primary measure of harms will be the rate of non-screening because initial test completion is a basic prerequisite for prevention of adverse CRC outcomes by a screening process. It is a readily measurable, basic quality assessment. Processes associated with high rates of non-screening would be expected to result in poor long term CRC outcomes.
Cost: Cost per-patient effectively screened.
Time frame: All outcomes will be adjudicated within 3 years.
The primary measure of costs will be the cost per-patient effectively screened from the health system perspective, with effective screening defined by the proportion of patients achieving an effective screening "success." Follow up time for cost-assessment will start at randomization and end either when a patient reaches an effective screening "success" endpoint, or at the end of the three year-follow up time. This outcome addresses a practical question most health systems will have in assessing our screening strategy: What is the strategy specific cost per-patient effectively screened?
8 secondary outcomes
Benefit: Number of CRCs, advanced adenomas, and adenomas detected.
Time frame: All outcomes will be adjudicated within 3 years.
Benefit: Number of patients screened.
Time frame: All outcomes will be adjudicated within 3 years.
Harm: Number of CRCs diagnosed based on symptoms/signs rather than screening.
Time frame: All outcomes will be adjudicated within 3 years.
Harm: Ineffective screening.
Time frame: All outcomes will be adjudicated within 3 years.
Harm: Post-colonoscopy bleeding or perforation.
Time frame: All outcomes will be adjudicated within 3 years.
Harm: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.
Time frame: All outcomes will be adjudicated within 3 years.
Cost: Cost per patient screened.
Time frame: All outcomes will be adjudicated within 3 years.
Cost: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.
Time frame: All outcomes will be adjudicated within 3 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 26 Apr 2018.
- Derived from this study: PubMed 28873161Singal AG, Gupta S, Skinner CS, Ahn C, Santini NO, Agrawal D, Mayorga CA, Murphy C, Tiro JA, McCallister K, Sanders JM, Bishop WP, Loewen AC, Halm EA. Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):806-815. doi: 10.1001/jama.2017.11389.
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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.
Amit Singal, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIT Screening Strategy and Colon Screening Strategy in people with Colorectal Cancer, run by University of Texas Southwestern Medical Center 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 7 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 26 Apr 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?
Benefit: Proportion of patients achieving one of the effective screening "successes." (time frame: All outcomes will be adjudicated within 3 years.). The study lists 3 primary outcomes in all. 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 NCT01710215, which also lists 1 linked publication.
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 26 Apr 2018.