Colorectal Cancer ScreeningFITNCT04746469
Using Behavioral Science to Improve Colorectal Cancer Screening Rates With Mailed FIT Kits
A study testing Delayed automated phone call in people with Colorectal Cancer Screening, run by University of California, Los Angeles at 1 site in United States.
Trial summary
As a part of UCLA Health's continued goal of improving patient care the investigators are updating our mailing campaign for our FIT Kit colorectal cancer screening that the investigators administer 2 times per year to include an automated phone call reminder to patients who are overdue for average-risk colorectal… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Delayed automated phone call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2020to 1 Aug 2022
- 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
- Overdue for average-risk colorectal cancer screening
- Active primary care provider at UCLA seen within last 3 years
Who cannot join
- Inactive mychart status at time of enrollment
- Died within follow-up period
- Received FIT kit in prior 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Health Department of Medicine, Quality Office
Los Angeles, California, 90095
About this study
Official title: Impact of Automated Telephone Outreach on Colorectal Cancer Screening Uptake Among Patients Who Receive Mailed Fecal Immunochemical Tests (FIT)
As a part of UCLA Health's continued goal of improving patient care the investigators are updating our mailing campaign for our FIT Kit colorectal cancer screening that the investigators administer 2 times per year to include an automated phone call reminder to patients who are overdue for average-risk colorectal cancer screening and enrolled in a mailed FIT program. This will help the investigators evaluate if automated phone calls are effective at improving compliance with CRC screening, in addition to mailed FIT and embedded electronic health record (EHR) portal messages to patients.
Read the detailed description
UCLA Health has a biannual mailed FIT program designed to capture patients overdue for CRC screening who are average-risk for CRC. With every campaign, the investigators attempt to improve the return rates for patients receiving the FIT Kits. For the current campaign, all patients enrolled will receive usual care and the investigators are delivering an automated phone call to half the eligible patients reminding them to return their FIT kits and prompting them to request a new kit if needed. The investigators will investigate if this intervention increases the number of patients who complete the mailed Fit Kit or any type of CRC screening over a 6-month follow up period. This quality improvement project will help the investigators improve the processes of care for the patients, and community. If this phone call is successful the investigators will likely expand it to the entire population in future FIT Kit mailer campaigns. However, if it is not effective this will help the investigators minimize the number of calls/interventions the investigators send to patients and will hopefully allow for more useful outreach to patients in the future.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Delayed automated phone call
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed automated phone callBehavioural
Also called Cipher phone reminder
Cipher provides automated phone calls to patients; in this case the script for Cipher was modified to provide patients a reminder to return FIT kits, allow patients to request a new kit in case they need a replacement, and to allow patients to provide information if they already completed CRC screening
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal) |
| Intervention | Experimental | This group will receive standard FIT mailer protocol (as above) PLUS delayed automated phone reminder Receives: Behavioral: Delayed automated phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall colorectal cancer screening uptake (any modality)
Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.
Measured: 6 months
Secondary outcomes (1)
Colorectal cancer screening uptake by modality
Rate of completion of CRC screening by modality type
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start2 Sep 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- \~2500 patients who are overdue for average-risk CRC screening and are enrolled in UCLA Health biannual mailed FIT program will be randomized to either control (mailed FIT kit + standard messaging) or intervention (mailed FIT Kit + standard messaging + delayed automated phone reminder)
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel M. Croymans, MD, MBA, MS, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746469
- Sponsor's protocol ID
- IRB #19-001418
- Acronym
- FIT
- Status last verified
- Sep 2022
- First submitted
- 24 Jan 2021
- Last updated
- 13 Sep 2022
- 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 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Automated Telephone Outreach on Colorectal Cancer Screening Uptake Among Patients Who Receive Mailed Fecal Immunochemical Tests (FIT)
- ClinicalTrials.gov ID
- NCT04746469
- Acronym / sponsor ID
- FIT / IRB #19-001418
- Conditions
- Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 9 Feb 2021 (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.
As a part of UCLA Health's continued goal of improving patient care the investigators are updating our mailing campaign for our FIT Kit colorectal cancer screening that the investigators administer 2 times per year to include an automated phone call reminder to patients who are overdue for average-risk colorectal cancer screening and enrolled in a mailed FIT program. This will help the investigators evaluate if automated phone calls are effective at improving compliance with CRC screening, in addition to mailed FIT and embedded electronic health record (EHR) portal messages to patients.
Detailed description
UCLA Health has a biannual mailed FIT program designed to capture patients overdue for CRC screening who are average-risk for CRC. With every campaign, the investigators attempt to improve the return rates for patients receiving the FIT Kits. For the current campaign, all patients enrolled will receive usual care and the investigators are delivering an automated phone call to half the eligible patients reminding them to return their FIT kits and prompting them to request a new kit if needed. The investigators will investigate if this intervention increases the number of patients who complete the mailed Fit Kit or any type of CRC screening over a 6-month follow up period. This quality improvement project will help the investigators improve the processes of care for the patients, and community. If this phone call is successful the investigators will likely expand it to the entire population in future FIT Kit mailer campaigns. However, if it is not effective this will help the investigators minimize the number of calls/interventions the investigators send to patients and will hopefully allow for more useful outreach to patients in the future.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ~2500 patients who are overdue for average-risk CRC screening and are enrolled in UCLA Health biannual mailed FIT program will be randomized to either control (mailed FIT kit + standard messaging) or intervention (mailed FIT Kit + standard messaging + delayed automated phone reminder)
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal) |
| Intervention | Experimental | Behavioral: Delayed automated phone callThis group will receive standard FIT mailer protocol (as above) PLUS delayed automated phone reminder |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overdue for average-risk colorectal cancer screening
- Active primary care provider at UCLA seen within last 3 years
Key exclusion criteria (3 listed)
- Inactive mychart status at time of enrollment
- Died within follow-up period
- Received FIT kit in prior 6 months
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 |
|---|---|---|
| Delayed automated phone callAlso: Cipher phone reminderCipher provides automated phone calls to patients; in this case the script for Cipher was modified to provide patients a reminder to return FIT kits, allow patients to request a new kit in case they need a replacement, and to allow patients to provide information if they already completed CRC screening | Behavioural | Intervention |
Primary outcome
Overall colorectal cancer screening uptake (any modality)
Time frame: 6 months
Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.
1 secondary outcome
Colorectal cancer screening uptake by modality
Time frame: 6 months
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 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed automated phone call in people with Colorectal Cancer Screening, run by University of California, Los Angeles 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 13 Sep 2022. 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?
Overall colorectal cancer screening uptake (any modality) (time frame: 6 months). 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 2022.