Colorectal Cancer ScreeningNCT06805370
Additional Mailed FIT Kits
A study testing Mailed Additional FIT Kit in people with Colorectal Cancer Screening, run by University of Southern California at 1 site in United States.
Trial summary
This study aims to assess whether sending patients in a county health care system additional FIT Kits can increase the FIT Kit return rate enough to warrant the extra cost. To do this, the health system mailed a random subset of patients ages 60 to 75 a FIT Kit in November 2024 in addition to sending patients an… Read more about this study
- Who is it for?
- Ages 60 to 74 years
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Mailed Additional FIT Kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 31 Mar 2025
- 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 60 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-74
- Due for colorectal cancer screening;
- Not sent a FIT Kit in the past 3-months;
- Previously successfully returned a FIT Kit.
Who cannot join
- Under age 60 or over age 74;
- Incarcerated;
- Not due for colorectal cancer screening;
- Sent a FIT Kit in the past 3-months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Additional Mailed FIT Kits
This study aims to assess whether sending patients in a county health care system additional FIT Kits can increase the FIT Kit return rate enough to warrant the extra cost. To do this, the health system mailed a random subset of patients ages 60 to 75 a FIT Kit in November 2024 in addition to sending patients an annual FIT Kit mailing. This work analyzes the return rate of mailed FIT Kits within 60-days of the November mailing.
Read the detailed description
This study aims to assess whether sending patients in a county health care system additional FIT Kits can increase the FIT Kit return rate enough to warrant the extra cost. To do this, patients ages 60 to 75 due for colorectal cancer screening, who had not received a FIT Kit in the previous 3 months but had completed one sometime in the past and had an assigned primary care provider, were randomized to be sent a FIT Kit in November of 2024 or to usual care. Usual care includes an annual FIT Kit mailing. We will analyze the successful return rate of mailed FIT Kits within 60-days of the November mailing.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Mailed Additional FIT Kit, Usual Care
- Keywords
- fecal immunochemical test (FIT), cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed Additional FIT KitBehavioural
Mailed additional FIT Kits in November 2024.
Usual CareOther
This group was sent an annual FIT Kit per usual care.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Annual FIT Kit Only) | Active comparator | This arm was sent an annual FIT Kit but was not sent a follow-up FIT Kit in November 2024. Receives: Other: Usual Care |
| Mailed Additional FIT Kit | Experimental | This arm was sent a follow-up FIT Kit in November 2024 in addition to the annual FIT Kit mailing. Receives: Behavioral: Mailed Additional FIT Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIT Kit return rate
Indicator of whether a patient successfully returned a FIT Kit to the health system for processing
Measured: 60-Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Nov 2024
- Primary completion28 Feb 2025
- Study completion31 Mar 2025
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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireille Jacobson, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805370
- Sponsor's protocol ID
- CCHS-QIP-SECOND-FIT-KIT
- Status last verified
- Jun 2025
- First submitted
- 15 Jan 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers can apply for permission to use anonymized data from CCHS.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Additional Mailed FIT Kits
- ClinicalTrials.gov ID
- NCT06805370
- Acronym / sponsor ID
- CCHS-QIP-SECOND-FIT-KIT
- Conditions
- Colorectal Cancer Screening
- Keywords
- fecal immunochemical test (FIT), cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 3 Feb 2025 (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 study aims to assess whether sending patients in a county health care system additional FIT Kits can increase the FIT Kit return rate enough to warrant the extra cost. To do this, the health system mailed a random subset of patients ages 60 to 75 a FIT Kit in November 2024 in addition to sending patients an annual FIT Kit mailing. This work analyzes the return rate of mailed FIT Kits within 60-days of the November mailing.
Detailed description
This study aims to assess whether sending patients in a county health care system additional FIT Kits can increase the FIT Kit return rate enough to warrant the extra cost. To do this, patients ages 60 to 75 due for colorectal cancer screening, who had not received a FIT Kit in the previous 3 months but had completed one sometime in the past and had an assigned primary care provider, were randomized to be sent a FIT Kit in November of 2024 or to usual care. Usual care includes an annual FIT Kit mailing. We will analyze the successful return rate of mailed FIT Kits within 60-days of the November mailing.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Annual FIT Kit Only) | Active comparator | Other: Usual CareThis arm was sent an annual FIT Kit but was not sent a follow-up FIT Kit in November 2024. |
| Mailed Additional FIT Kit | Experimental | Behavioral: Mailed Additional FIT KitThis arm was sent a follow-up FIT Kit in November 2024 in addition to the annual FIT Kit mailing. |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60-74
- Due for colorectal cancer screening;
- Not sent a FIT Kit in the past 3-months;
- Previously successfully returned a FIT Kit.
Key exclusion criteria (4 listed)
- Under age 60 or over age 74;
- Incarcerated;
- Not due for colorectal cancer screening;
- Sent a FIT Kit in the past 3-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 |
|---|---|---|
| Mailed Additional FIT KitMailed additional FIT Kits in November 2024. | Behavioural | Mailed Additional FIT Kit |
| Usual CareThis group was sent an annual FIT Kit per usual care. | Other | Usual Care (Annual FIT Kit Only) |
Primary outcome
FIT Kit return rate
Time frame: 60-Days
Indicator of whether a patient successfully returned a FIT Kit to the health system for processing
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 5 Jun 2025.
- Individual participant dataSharing planned: No. Researchers can apply for permission to use anonymized data from CCHS.
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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 Mailed Additional FIT Kit in people with Colorectal Cancer Screening, run by University of Southern California 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 4 inclusion and 4 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 5 Jun 2025. 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?
FIT Kit return rate (time frame: 60-Days). 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 5 Jun 2025.