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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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:

  1. Complete a free home-based, non-invasive immunochemical stool blood test
  2. 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.

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 groups in NCT01191411
Study groupRoleWhat they receive
Mailed invitations for FIT test kitsActive comparatorFecal 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 colonoscopyActive comparatorInvitation 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 CareActive comparatorNo 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.

  1. 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.

  1. First posted30 Aug 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

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)
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
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

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.

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