Colorectal CancerNCT03414125
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
A study testing FIT Screening Strategy and Choice Screening Strategy in people with Colorectal Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening colonoscopy increases CRC screening completion compared… Read more about this study
- Who is it for?
- Ages 50 to 63 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FIT Screening Strategy and Choice Screening Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26,859 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 31 Aug 2021
- 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 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females
- Age 50-64 years
- Seen at least one time at a Parkland primary care clinic within one year prior to randomization
- Participants in Parkland's medical assistance program for the uninsured (Parkland Financial Assistance)
- 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
- 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: Comparing the Effect of a Mailed Outreach Intervention Offering Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening Outcomes: A Pragmatic Randomized Control Trial in a Safety Net Health System
This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program (which does not offer an explicit choice of screening modality). The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system that has a "FIT first" population health screening strategy. All patients will also have access to whatever CRC screening is recommended through usual visit-based care.
Read the detailed description
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. In the NCI-funded UT Southwestern-Parkland PROSPR Center (U54 CA163308), mailed FIT-based outreach doubled the proportion of patients up-to-date with screening compared to usual care. Investigators are now conducting a comparative effectiveness trial to evaluate the effect of a mailed invite offering a choice of FIT or colonoscopy (n=2,000) on one-time CRC screening completion compared to mailed FIT-based outreach (which does not offer an explicit choice of screening modality (n=8,000.) Randomization will be stratified based on whether or not patients completed a FIT within the prior 18-month period. Patients randomized to FIT outreach will receive: a) low-literacy educational letters, b) mailed screening outreach invitations, c) a one-sample home FIT kit and return mailer with prepaid postage, d) telephone reminder calls including one-on-one education, and e) centralized patient navigation for follow-up of abnormal screening results, and treatment for patients newly diagnosed with CRC. Patients randomized to the "choice" arm will receive the same materials described above; however, the educational letter will explain and offer the additional choice of screening by colonoscopy (instead of completing the mailed FIT kit). The mailing will include a low health literacy one-page option grid outlining the pros and cons of FIT vs. colonoscopy. We will not recommend a particular test as preferred but instead emphasize that both are good choices, and the patient should choose the screening option that seems right for them. Patients choosing colonoscopy will be provided a telephone number to schedule the procedure. During scheduling, patients will be triaged by study staff with a structured history and physical form to "direct access" colonoscopy or a pre-colonoscopy clinic visit. Patients choosing FIT can return the one-sample mailed FIT kit using the return envelope with prepaid postage.
- Conditions
- Colorectal Cancer
- Being tested
- FIT Screening Strategy, Choice Screening Strategy
- Keywords
- Colorectal Cancer, Colon Cancer, FIT Screening Strategy, Colon Screening Strategy, Colorectal Neoplasms, 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. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).
Up to three "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.
Choice Screening StrategyOther
Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy.
Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences. Outreach includes: 1) invitation letter, 2) choice grid 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).
Up to three "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 |
|---|---|---|
| FIT Screening Strategy | Active comparator | Mailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).
Up to three "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 |
| Choice Screening Strategy | Experimental | Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy.
Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences.
Choice Strategy outreach invitation includes: 1) invitation letter, 2) option grid comparing FIT and colonoscopy 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).
Up to three "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: Choice Screening Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-time Screening Completion
Proportion of patients who complete CRC screening with colonoscopy, sigmoidoscopy, or FIT
Measured: Within one year of randomization
Secondary outcomes (2)
Screening Up-to-date
Screening Up-to-date status
Measured: At 2 and 3 years post-randomization
Choice of FIT versus Colonoscopy
Proportion of patients who choose FIT versus colonoscopy
Measured: Within 6 months of invitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start7 Sep 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Evaluate effect of offering choice of FIT or colonoscopy (n=2,000) compared to FIT alone (n=8,000) on one-time CRC screening completion, repeat screening, and follow-up of abnormal FIT results.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26,859 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, Parkland Health and Hospital System
- Responsible party
- Principal investigator, Amit Singal, University of Texas Southwestern Medical Center
- Investigators
- Amit Singal, MD, MS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414125
- Sponsor's protocol ID
- STU 082016-060
- Other IDs
- 21985, PP160075
- Status last verified
- Sep 2021
- First submitted
- 22 Jan 2018
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of a Mailed Outreach Intervention Offering Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening Outcomes: A Pragmatic Randomized Control Trial in a Safety Net Health System
- ClinicalTrials.gov ID
- NCT03414125
- Acronym / sponsor ID
- STU 082016-060
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Colon Cancer, FIT Screening Strategy, Colon Screening Strategy, Colorectal Neoplasms, Mass Screening, Health Services Research, Comparative Effectiveness Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26,859 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, Parkland Health and Hospital System
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 29 Jan 2018 (actual)
- 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 is a pragmatic, randomized, controlled trial comparing whether a mailed outreach intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program (which does not offer an explicit choice of screening modality). The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system that has a "FIT first" population health screening strategy. All patients will also have access to whatever CRC screening is recommended through usual visit-based care.
Detailed description
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. In the NCI-funded UT Southwestern-Parkland PROSPR Center (U54 CA163308), mailed FIT-based outreach doubled the proportion of patients up-to-date with screening compared to usual care. Investigators are now conducting a comparative effectiveness trial to evaluate the effect of a mailed invite offering a choice of FIT or colonoscopy (n=2,000) on one-time CRC screening completion compared to mailed FIT-based outreach (which does not offer an explicit choice of screening modality (n=8,000.) Randomization will be stratified based on whether or not patients completed a FIT within the prior 18-month period. Patients randomized to FIT outreach will receive: a) low-literacy educational letters, b) mailed screening outreach invitations, c) a one-sample home FIT kit and return mailer with prepaid postage, d) telephone reminder calls including one-on-one education, and e) centralized patient navigation for follow-up of abnormal screening results, and treatment for patients newly diagnosed with CRC. Patients randomized to the "choice" arm will receive the same materials described above; however, the educational letter will explain and offer the additional choice of screening by colonoscopy (instead of completing the mailed FIT kit). The mailing will include a low health literacy one-page option grid outlining the pros and cons of FIT vs. colonoscopy. We will not recommend a particular test as preferred but instead emphasize that both are good choices, and the patient should choose the screening option that seems right for them. Patients choosing colonoscopy will be provided a telephone number to schedule the procedure. During scheduling, patients will be triaged by study staff with a structured history and physical form to "direct access" colonoscopy or a pre-colonoscopy clinic visit. Patients choosing FIT can return the one-sample mailed FIT kit using the return envelope with prepaid postage.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Evaluate effect of offering choice of FIT or colonoscopy (n=2,000) compared to FIT alone (n=8,000) on one-time CRC screening completion, repeat screening, and follow-up of abnormal FIT results.
| Arm | Type | Receives |
|---|---|---|
| FIT Screening Strategy | Active comparator | Other: FIT Screening StrategyMailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage). Up to three "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. |
| Choice Screening Strategy | Experimental | Other: Choice Screening StrategyMailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy. Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences. Choice Strategy outreach invitation includes: 1) invitation letter, 2) option grid comparing FIT and colonoscopy 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage). Up to three "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 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females
- Age 50-64 years
- Seen at least one time at a Parkland primary care clinic within one year prior to randomization
- Participants in Parkland's medical assistance program for the uninsured (Parkland Financial Assistance)
- All races and ethnicities
Key exclusion criteria (6 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 StrategyMailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage). Up to three "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 |
| Choice Screening StrategyMailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy. Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences. Outreach includes: 1) invitation letter, 2) choice grid 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage). Up to three "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 | Choice Screening Strategy |
Primary outcome
One-time Screening Completion
Time frame: Within one year of randomization
Proportion of patients who complete CRC screening with colonoscopy, sigmoidoscopy, or FIT
2 secondary outcomes
Screening Up-to-date
Time frame: At 2 and 3 years post-randomization
Choice of FIT versus Colonoscopy
Time frame: Within 6 months of invitation
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 13 Sep 2021.
- 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.
Amit Singal, MD, MS 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 Choice 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 6 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 13 Sep 2021. 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?
One-time Screening Completion (time frame: Within one year of randomization). 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 13 Sep 2021.