Colonic NeoplasmsNCT02613260
Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
A study testing FIT Outreach in people with Colonic Neoplasms, run by University of California, San Francisco at 1 site in United States.
Trial summary
Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network and access to care may be limited so novel models of health care delivery are warranted. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- FIT Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,470 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 1 Jan 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic men and women
- 50 to 75 years of age
Who cannot join
- Personal history of polyps requiring colonoscopic surveillance
- Homeless
- Severe co-morbidities limiting life expectancy e.g., advanced stage cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco-San Francisco General Hospital
San Francisco, California, 94110
About this study
Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network and access to care may be limited so novel models of health care delivery are warranted. The objective of this study is to examine whether a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses.
Read the detailed description
Rationale: Since uptake of colorectal cancer (CRC) screening is suboptimal in the SF safety-net system and access to care may be limited, novel models of health care delivery are warranted. The overall hypothesis is that a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses. Barriers to immunization of adults include missed opportunities during visits, limited access to providers, and provider and patient beliefs of efficacy.
Design: To rigorously examine the benefit of the centralized panel management to improve uptake of CRC screening with mailed FIT, the electronic health system will be used to identify eligible patients who are not up-to-date with CRC screening. Broadly, patients will be randomized 1:1 to usual care or intervention arm, stratified by clinic, gender, prior screening, and race to receive mailed FIT kits + usual care versus usual care alone. The cost-effectiveness of no screening, usual care, and centralized management with mailed FIT outreach will be compared using mathematical simulation models.
- Conditions
- Colonic Neoplasms
- Being tested
- FIT Outreach
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT OutreachBehavioural
This arm will consist of priming patients with a postcard and a possibly a phone call two weeks prior to them being mailed a FIT kit. The FIT kits will be mailed to the patients with a letter from their clinic's care team informing them why they should complete the FIT and wordless instructions to help them complete the FIT. Two weeks after the FIT kit is mailed the patients that have not returned the kit will receive up to two reminder calls. During the phone calls the outreach workers will use health coaching techniques to encourage patients to complete the FIT. All written materials have been translated into English and Chinese and during phone calls patients will be spoken to in the language that they are most comfortable using.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients in this study arm will receive usual care from their primary care clinic. |
| FIT Outreach + Usual Care | Experimental | Patients in this study arm will receive usual care at their primary care clinic and the intervention. Receives: Behavioral: FIT Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of FIT- one year
The primary outcome is the completion rate for CRC screening one-year after randomization between mailed FIT outreach and usual care.
Measured: One year
Secondary outcomes (5)
Incomplete FIT- 28 days
Of the patients mailed the FIT kit the number of patients that have not completed their FIT.
Measured: 28 days
FIT Positive
Among the patients that have completed the FIT the percentage that had a positive FIT test.
Measured: 1 year
Completed Colonoscopy
Of the patients that had a positive FIT the percentage of patients that received a colonoscopy.
Measured: One year
Colonoscopy Findings
Of the patients that received a colonoscopy what were the findings (rate of any adenoma, advanced neoplasia, and colorectal cancer).
Measured: One year
Cost
How much the program costed to start and the costs throughout program implementation.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, San Francisco Department of Public Health
- Responsible party
- Principal investigator, Ma Somsouk, MD, MAS, University of California, San Francisco
- Investigators
- Ma Somsouk, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613260
- Sponsor's protocol ID
- 14-14861
- Status last verified
- Aug 2019
- First submitted
- 20 Nov 2015
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
McClellan SP, Canchola AJ, Potter MB, Gomez SL, Somsouk M. Neighborhood socioeconomic status and the effectiveness of colorectal cancer screening outreach with mailed fecal immunochemical tests within a safety net healthcare system in San Francisco, CA: A subgroup analysis of a randomized controlled trial. Prev Med. 2023 Feb;167:107388. doi: 10.1016/j.ypmed.2022.107388. Epub 2022 Dec 14.
PubMed 36528113Lee B, Keyes E, Rachocki C, Grimes B, Chen E, Vittinghoff E, Ladabaum U, Somsouk M. Increased Colorectal Cancer Screening Sustained with Mailed Fecal Immunochemical Test Outreach. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1326-1333.e4. doi: 10.1016/j.cgh.2021.07.022. Epub 2021 Jul 16.
PubMed 34280552Wang A, Rachocki C, Shapiro JA, Issaka RB, Somsouk M. Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1822-1828. doi: 10.1016/j.cgh.2018.11.050. Epub 2018 Nov 29.
PubMed 30503967
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
- ClinicalTrials.gov ID
- NCT02613260
- Acronym / sponsor ID
- 14-14861
- Conditions
- Colonic Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,470 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Stanford University, San Francisco Department of Public Health
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network and access to care may be limited so novel models of health care delivery are warranted. The objective of this study is to examine whether a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses.
Detailed description
Rationale: Since uptake of colorectal cancer (CRC) screening is suboptimal in the SF safety-net system and access to care may be limited, novel models of health care delivery are warranted. The overall hypothesis is that a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses. Barriers to immunization of adults include missed opportunities during visits, limited access to providers, and provider and patient beliefs of efficacy.
Design: To rigorously examine the benefit of the centralized panel management to improve uptake of CRC screening with mailed FIT, the electronic health system will be used to identify eligible patients who are not up-to-date with CRC screening. Broadly, patients will be randomized 1:1 to usual care or intervention arm, stratified by clinic, gender, prior screening, and race to receive mailed FIT kits + usual care versus usual care alone. The cost-effectiveness of no screening, usual care, and centralized management with mailed FIT outreach will be compared using mathematical simulation models.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients in this study arm will receive usual care from their primary care clinic. |
| FIT Outreach + Usual Care | Experimental | Behavioral: FIT OutreachPatients in this study arm will receive usual care at their primary care clinic and the intervention. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asymptomatic men and women
- 50 to 75 years of age
Key exclusion criteria (3 listed)
- Personal history of polyps requiring colonoscopic surveillance
- Homeless
- Severe co-morbidities limiting life expectancy e.g., advanced stage cancer
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 OutreachThis arm will consist of priming patients with a postcard and a possibly a phone call two weeks prior to them being mailed a FIT kit. The FIT kits will be mailed to the patients with a letter from their clinic's care team informing them why they should complete the FIT and wordless instructions to help them complete the FIT. Two weeks after the FIT kit is mailed the patients that have not returned the kit will receive up to two reminder calls. During the phone calls the outreach workers will use health coaching techniques to encourage patients to complete the FIT. All written materials have been translated into English and Chinese and during phone calls patients will be spoken to in the language that they are most comfortable using. | Behavioural | FIT Outreach + Usual Care |
Primary outcome
Completion of FIT- one year
Time frame: One year
The primary outcome is the completion rate for CRC screening one-year after randomization between mailed FIT outreach and usual care.
5 secondary outcomes
Incomplete FIT- 28 days
Time frame: 28 days
FIT Positive
Time frame: 1 year
Completed Colonoscopy
Time frame: One year
Colonoscopy Findings
Time frame: One year
Cost
Time frame: Two 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 9 Aug 2019.
- Derived from this study: PubMed 36528113McClellan SP, Canchola AJ, Potter MB, Gomez SL, Somsouk M. Neighborhood socioeconomic status and the effectiveness of colorectal cancer screening outreach with mailed fecal immunochemical tests within a safety net healthcare system in San Francisco, CA: A subgroup analysis of a randomized controlled trial. Prev Med. 2023 Feb;167:107388. doi: 10.1016/j.ypmed.2022.107388. Epub 2022 Dec 14.
- Derived from this study: PubMed 34280552Lee B, Keyes E, Rachocki C, Grimes B, Chen E, Vittinghoff E, Ladabaum U, Somsouk M. Increased Colorectal Cancer Screening Sustained with Mailed Fecal Immunochemical Test Outreach. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1326-1333.e4. doi: 10.1016/j.cgh.2021.07.022. Epub 2021 Jul 16.
- Derived from this study: PubMed 30503967Wang A, Rachocki C, Shapiro JA, Issaka RB, Somsouk M. Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1822-1828. doi: 10.1016/j.cgh.2018.11.050. Epub 2018 Nov 29.
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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.
Ma Somsouk, MD principal investigator
University of California, San Francisco
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 Outreach in people with Colonic Neoplasms, run by University of California, San Francisco 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 2 inclusion and 3 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 9 Aug 2019. 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?
Completion of FIT- one year (time frame: One 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 NCT02613260, which also lists 3 linked publications.
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 9 Aug 2019.