Colorectal CancerNCT01191411
Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs
A study testing Mailed invitations for FIT test kits, Mailed invitations for a colonoscopy and Visit Based Care in people with Colorectal Cancer, run by University of Texas Southwestern Medical Center.
Trial summary
Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations such as those with limited or no health insurance. Read more about this study
- Who is it for?
- Ages 54 to 64 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Mailed invitations for FIT test kits, Mailed invitations for a colonoscopy and Visit Based Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,970 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 54 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 54 to 64 year old men and women
- All races and ethnicities
- Patients that have been on JPS Connection in 2010 or JPS Connection in 2009 and have been seen at least once between September 1, 2009 and August 31, 2010 in any JPS setting
Who cannot join
- No address and phone number on file
- Incarcerated individuals
- Primary language other than English or Spanish
- Up to date with CRC screening, defined as any:
- Fecal Occult Blood Test (FOBT) in 2009
- Flexible Sigmoidoscopy 2005-09
- Barium Enema 2005-09
- Colonoscopy 2002-09* Prior history of CRC, inflammatory bowel disease, or colorectal polyps.
About this study
Official title: Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs.
Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations such as those with limited or no health insurance. This striking public health challenge demands urgent implementation of evidence-based strategies to reduce avoidable CRC death.
Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to complete CRC screening may result in increased rates of screening completion. However, this approach has not been tested extensively in vulnerable populations, such as the under/uninsured, and minority populations often cared for by safety-net health systems. Further, it is unclear whether patients are more likely to participate in one CRC screening test versus another. Knowing this is important to designing programs for increasing screening. For example, the planning and resources required for a screening program with colonoscopy--which is a sensitive but invasive and expensive test--are very different from a program with that uses stool testing to detect microscopic blood such as an immunochemical stool blood test--which is a less sensitive, but non-invasive and cheap test.
Read more
Also, it is possible designing a program with a less sensitive, but more acceptable test could prevent more CRC death if participation in screening is test specific. For example, if many more patients participate in an immunochemical stool blood test based program than a colonoscopy based program, even though the immunochemical stool blood test is less sensitive, the program may save more lives because more patients are reached.
The aims of this trial are to:
Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders, and systematic clinical follow up) to uninsured, unscreened patients cared for by the safety-net health system serving Tarrant County, Texas. Patients will be invited to either:
- Complete a free home-based, non-invasive immunochemical stool blood test
- Complete a free colonoscopy
Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program costs.
The primary outcome is screening completion.
Read the detailed description
Program setting. The John Peter Smith Hospital Health System (JPS) is a safety-net health care system serving Tarrant County, Texas (including Fort Worth), with over 850,000 yearly patient encounters. JPS qualifies as a safety-net health system based on a commitment to deliver health care to uninsured, Medicaid participants, and other vulnerable patients18, and is recognized as a disproportionate share hospital. JPS offers a tax-subsidized charity medical program called JPS Connection for uninsured Tarrant County residents who are not eligible for state or federal assistance programs such as Medicaid, with qualification based on federal poverty income levels.
Target population. Our specific project target population includes men and women, aged 54 to 64, without prior CRC screening, of all races/ethnicities (including African Americans, Hispanics, and Whites), who are primary English or Spanish language speaking, and uninsured but enrolled in the JPS Connection medical assistance program. We include only those individuals who qualify and are enrolled in the JPS Connection medical assistance program to ensure that all included patients have access to a primary provider, as well as surgical and medical cancer care, in the event that a patient has a cancer diagnosed.
TREATMENT (INTERVENTION) We will screen the administrative dataset that we are using to identify potential study participants for individuals who meet inclusion criteria. All patients selected to one of the programmatic screening approaches (Mailed FIT or Mailed Colonoscopy invitation) will receive the same, structured approach for encouragement of completion of CRC screening with the exception of the initial screening modality offered (e.g. FIT or colonoscopy). In addition, patients selected for program intervention will also be free to engage in usual medical care, and any associated visit-based screening at the discretion and preference of the individual and primary medical provider.
Mailed invitation program procedures. Every 3 months, ¼ of the patient group selected for the mail out program will receive an electronic, automated phone call, alerting them that an invitation to participate in CRC screening will be mailed to them shortly. All invitees, regardless of screen-group, will receive: 1) Invitation to participate in CRC screening with a specific test, including discussion of importance of screening, 2) Return card that may request to not participate in screening/be contacted in the future ("opt out" request). The invitations will be sent every 3 months in batches, rather than all at once, to allocate manpower resources for program follow up, and colonoscopy services as necessary for positive tests or screening requests.
Alert and reminder phone calls. At time of initial mailing of the invitation, a "TeleVox©" automated phone message, with a pre-recorded script (in both English and Spanish) will be generated to alert participants that an invitation is "in-the-mail." Fourteen days after initial mailing of the invitation, a "TeleVox©" automated reminder to respond to the invitation for screening with a pre-recorded script (in both English and Spanish) will be generated for all participants. Twenty-one to 36 days after initial invitation to testing, a "live" reminder phone call will be initiated by the screening coordination team for all individuals who have not responded to screening invitation. Up to 2 attempts will be made to contact individuals via phone; reaching a voice mail, an adult household member, or the target study participant will be considered a successful attempt. Reaching a disconnected, busy line, or line that rings with no answer on two attempts will be considered unsuccessful attempt. Continued intervention and follow up will not be based on whether or not phone call attempts were successful-all patients included in the program will be assessed for the outcome of screening participation.
Invitation letters. The invitation letters for screening with FIT or colonoscopy will contain the following elements: 1) Statement that risk of getting colon cancer increases with age and that screening can reduce the consequences, 2) Invitation to a specific modality, (FIT or colonoscopy) with a succinct description of the test, 3) Number to call with questions, 4) In the case of colonoscopy invitation, number to call to sign up, 5) Signature from a physician at JPS.
FIT procedures. Individuals assigned to FIT will be provided with written instructions on how to collect the stool samples for FIT testing. Kits will be mailed using return envelopes with pre-paid postage to a JPS.
Colonoscopy procedures. The colonoscopy invitation will consist of an explanation of colonoscopy, as well as a phone number to call to schedule a colonoscopy ("direct book") or a pre-colonoscopy clinic visit. The decision to "direct book" for colonoscopy or to arrange for a pre-colonoscopy clinic visit will be based on screening nurse phone interview using a short screening form. If potential medical contraindications to colonoscopy are noted, a pre-colonoscopy visit will be scheduled with a physician at JPS. Patients with uncontrolled medical conditions will be referred to primary physicians for further management and to consider CRC screening once the condition is under control. Reasons for not scheduling colonoscopy will be documented. The patient will receive a date and time assignment for the colonoscopy procedure, and instructions on bowel preparation for the procedure. The preparation kit will be mailed to the patient's home. Reminder calls 5-7 days prior to the procedure to confirm the date and time of the procedure, review bowel preparation instructions, and answer any questions will occur. The day of the procedure, a history and physical will be performed to re-assess for any contraindications for colonoscopy. Polyps identified will be removed completely, with repeat colonoscopy and/or surgery if polyp removal not successful. Any mass lesions and any areas of inflamed or irregular colon mucosa will undergo biopsy. Endoscopy findings will be reviewed with each participant.
Test Follow Up. Individuals with positive FIT will be contacted to schedule a colonoscopy, with the goal of test completion within 8-12 weeks of test positivity. If phone contact for test scheduling cannot be established, a certified letter will be sent. Individuals with findings of adenoma or cancer on colonoscopy will be scheduled for a follow up, post-colonoscopy visit with the endoscopist who performed the procedure. Individuals with normal FIT or colonoscopy screening tests will have a letter mailed to his or her home, as well as the primary outpatient clinic identified by administrative data.
- Conditions
- Colorectal Cancer
- Being tested
- Mailed invitations for FIT test kits, Mailed invitations for a colonoscopy, Visit Based Care
- Keywords
- colorectal neoplasms, screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed invitations for FIT test kitsOther
Also called Polymedco Fecal Immunochemical Test
Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.
Mailed invitations for a colonoscopyOther
These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.
Visit Based CareOther
Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.
| Study group | Role | What they receive |
|---|---|---|
| Mailed invitations for FIT test kits | Active comparator | Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy. Receives: Other: Mailed invitations for FIT test kits |
| Mailed invitations for a colonoscopy | Active comparator | Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure. Receives: Other: Mailed invitations for a colonoscopy |
| Visit Based Care | Active comparator | No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care. Receives: Other: Visit Based Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value<0.025 will be considered statistically significant.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,970 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, Polymedco Corporation
- Responsible party
- Sponsor
- Investigators
- Keith E Argenbright, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191411
- Sponsor's protocol ID
- STU 012011-152
- Status last verified
- Apr 2017
- First submitted
- 27 Aug 2010
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294.
PubMed 23921906
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs.
- ClinicalTrials.gov ID
- NCT01191411
- Acronym / sponsor ID
- STU 012011-152
- Conditions
- Colorectal Cancer
- Keywords
- colorectal neoplasms, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,970 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, Polymedco Corporation
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Posted 20 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations such as those with limited or no health insurance. This striking public health challenge demands urgent implementation of evidence-based strategies to reduce avoidable CRC death.
Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to complete CRC screening may result in increased rates of screening completion. However, this approach has not been tested extensively in vulnerable populations, such as the under/uninsured, and minority populations often cared for by safety-net health systems. Further, it is unclear whether patients are more likely to participate in one CRC screening test versus another. Knowing this is important to designing programs for increasing screening. For example, the planning and resources required for a screening program with colonoscopy--which is a sensitive but invasive and expensive test--are very different from a program with that uses stool testing to detect microscopic blood such as an immunochemical stool blood test--which is a less sensitive, but non-invasive and cheap test.
Also, it is possible designing a program with a less sensitive, but more acceptable test could prevent more CRC death if participation in screening is test specific. For example, if many more patients participate in an immunochemical stool blood test based program than a colonoscopy based program, even though the immunochemical stool blood test is less sensitive, the program may save more lives because more patients are reached.
The aims of this trial are to:
Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders, and systematic clinical follow up) to uninsured, unscreened patients cared for by the safety-net health system serving Tarrant County, Texas. Patients will be invited to either:
- Complete a free home-based, non-invasive immunochemical stool blood test
- Complete a free colonoscopy
Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program costs.
The primary outcome is screening completion.
Detailed description
Program setting. The John Peter Smith Hospital Health System (JPS) is a safety-net health care system serving Tarrant County, Texas (including Fort Worth), with over 850,000 yearly patient encounters. JPS qualifies as a safety-net health system based on a commitment to deliver health care to uninsured, Medicaid participants, and other vulnerable patients18, and is recognized as a disproportionate share hospital. JPS offers a tax-subsidized charity medical program called JPS Connection for uninsured Tarrant County residents who are not eligible for state or federal assistance programs such as Medicaid, with qualification based on federal poverty income levels.
Target population. Our specific project target population includes men and women, aged 54 to 64, without prior CRC screening, of all races/ethnicities (including African Americans, Hispanics, and Whites), who are primary English or Spanish language speaking, and uninsured but enrolled in the JPS Connection medical assistance program. We include only those individuals who qualify and are enrolled in the JPS Connection medical assistance program to ensure that all included patients have access to a primary provider, as well as surgical and medical cancer care, in the event that a patient has a cancer diagnosed.
TREATMENT (INTERVENTION) We will screen the administrative dataset that we are using to identify potential study participants for individuals who meet inclusion criteria. All patients selected to one of the programmatic screening approaches (Mailed FIT or Mailed Colonoscopy invitation) will receive the same, structured approach for encouragement of completion of CRC screening with the exception of the initial screening modality offered (e.g. FIT or colonoscopy). In addition, patients selected for program intervention will also be free to engage in usual medical care, and any associated visit-based screening at the discretion and preference of the individual and primary medical provider.
Mailed invitation program procedures. Every 3 months, ¼ of the patient group selected for the mail out program will receive an electronic, automated phone call, alerting them that an invitation to participate in CRC screening will be mailed to them shortly. All invitees, regardless of screen-group, will receive: 1) Invitation to participate in CRC screening with a specific test, including discussion of importance of screening, 2) Return card that may request to not participate in screening/be contacted in the future ("opt out" request). The invitations will be sent every 3 months in batches, rather than all at once, to allocate manpower resources for program follow up, and colonoscopy services as necessary for positive tests or screening requests.
Alert and reminder phone calls. At time of initial mailing of the invitation, a "TeleVox©" automated phone message, with a pre-recorded script (in both English and Spanish) will be generated to alert participants that an invitation is "in-the-mail." Fourteen days after initial mailing of the invitation, a "TeleVox©" automated reminder to respond to the invitation for screening with a pre-recorded script (in both English and Spanish) will be generated for all participants. Twenty-one to 36 days after initial invitation to testing, a "live" reminder phone call will be initiated by the screening coordination team for all individuals who have not responded to screening invitation. Up to 2 attempts will be made to contact individuals via phone; reaching a voice mail, an adult household member, or the target study participant will be considered a successful attempt. Reaching a disconnected, busy line, or line that rings with no answer on two attempts will be considered unsuccessful attempt. Continued intervention and follow up will not be based on whether or not phone call attempts were successful-all patients included in the program will be assessed for the outcome of screening participation.
Invitation letters. The invitation letters for screening with FIT or colonoscopy will contain the following elements: 1) Statement that risk of getting colon cancer increases with age and that screening can reduce the consequences, 2) Invitation to a specific modality, (FIT or colonoscopy) with a succinct description of the test, 3) Number to call with questions, 4) In the case of colonoscopy invitation, number to call to sign up, 5) Signature from a physician at JPS.
FIT procedures. Individuals assigned to FIT will be provided with written instructions on how to collect the stool samples for FIT testing. Kits will be mailed using return envelopes with pre-paid postage to a JPS.
Colonoscopy procedures. The colonoscopy invitation will consist of an explanation of colonoscopy, as well as a phone number to call to schedule a colonoscopy ("direct book") or a pre-colonoscopy clinic visit. The decision to "direct book" for colonoscopy or to arrange for a pre-colonoscopy clinic visit will be based on screening nurse phone interview using a short screening form. If potential medical contraindications to colonoscopy are noted, a pre-colonoscopy visit will be scheduled with a physician at JPS. Patients with uncontrolled medical conditions will be referred to primary physicians for further management and to consider CRC screening once the condition is under control. Reasons for not scheduling colonoscopy will be documented. The patient will receive a date and time assignment for the colonoscopy procedure, and instructions on bowel preparation for the procedure. The preparation kit will be mailed to the patient's home. Reminder calls 5-7 days prior to the procedure to confirm the date and time of the procedure, review bowel preparation instructions, and answer any questions will occur. The day of the procedure, a history and physical will be performed to re-assess for any contraindications for colonoscopy. Polyps identified will be removed completely, with repeat colonoscopy and/or surgery if polyp removal not successful. Any mass lesions and any areas of inflamed or irregular colon mucosa will undergo biopsy. Endoscopy findings will be reviewed with each participant.
Test Follow Up. Individuals with positive FIT will be contacted to schedule a colonoscopy, with the goal of test completion within 8-12 weeks of test positivity. If phone contact for test scheduling cannot be established, a certified letter will be sent. Individuals with findings of adenoma or cancer on colonoscopy will be scheduled for a follow up, post-colonoscopy visit with the endoscopist who performed the procedure. Individuals with normal FIT or colonoscopy screening tests will have a letter mailed to his or her home, as well as the primary outpatient clinic identified by administrative data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mailed invitations for FIT test kits | Active comparator | Other: Mailed invitations for FIT test kitsFecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening. Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care. Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy. |
| Mailed invitations for a colonoscopy | Active comparator | Other: Mailed invitations for a colonoscopyInvitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening. Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care. Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure. |
| Visit Based Care | Active comparator | Other: Visit Based CareNo invitation to complete colorectal cancer screening. Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care. |
Who may qualify
- Ages
- 54 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 54 to 64 year old men and women
- All races and ethnicities
- Patients that have been on JPS Connection in 2010 or JPS Connection in 2009 and have been seen at least once between September 1, 2009 and August 31, 2010 in any JPS setting
Key exclusion criteria (8 listed)
- No address and phone number on file
- Incarcerated individuals
- Primary language other than English or Spanish
- Up to date with CRC screening, defined as any:
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 |
|---|---|---|
| Mailed invitations for FIT test kitsAlso: Polymedco Fecal Immunochemical TestMailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test. | Other | Mailed invitations for FIT test kits |
| Mailed invitations for a colonoscopyThese patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital. | Other | Mailed invitations for a colonoscopy |
| Visit Based CareVisit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would. | Other | Visit Based Care |
Primary outcome
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
Time frame: 1 year
To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value<0.025 will be considered statistically significant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23921906Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294.
- 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.
Keith E Argenbright, MD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Mailed invitations for FIT test kits, Mailed invitations for a colonoscopy and Visit Based Care in people with Colorectal Cancer, 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 8 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 23 May 2017. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem. (time frame: 1 year). 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 NCT01191411, 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 23 May 2017.