Colonic NeoplasmsNCT07173985
Strategies for Optimizing a Mailed FIT Program in Appalachia
A study testing Standard FIT kit, Enhanced FIT kit and Telephone patient navigation in people with Colonic Neoplasms, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The proposed study is examining strategies for optimizing mailed fecal immunochemical test (FIT) programs. In doing so, it will assess the efficacy of two promising strategies, FIT kit materials and patient navigation delivery mode. These strategies may help to improve colorectal cancer screening rates. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Standard FIT kit, Enhanced FIT kit and Telephone patient navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of an Appalachian county
- Medical visit at a participating health system in the past two years
- Average-risk for colorectal cancer
- Not currently within colorectal cancer screening guidelines
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Paul Reiter, PhD, 614-292-4803, reiter.36@osu.edu
brownstone587@yahoo.com
About this study
The proposed study is examining strategies for optimizing mailed fecal immunochemical test (FIT) programs. In doing so, it will assess the efficacy of two promising strategies, FIT kit materials and patient navigation delivery mode. These strategies may help to improve colorectal cancer screening rates.
Read the detailed description
PRIMARY OBJECTIVES:
Determine the efficacy of two strategies for increasing colorectal cancer screening.
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I: Participants receive a standard FIT kit plus telephone patient navigation.
GROUP II: Participants receive a standard FIT kit plus text message patient navigation.
GROUP III: Participants receive an enhanced FIT kit plus telephone patient navigation.
GROUP IV: Participants receive an enhanced FIT kit plus text message patient navigation.
- Conditions
- Colonic Neoplasms
- Being tested
- Standard FIT kit, Enhanced FIT kit, Telephone patient navigation, Text message patient navigation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard FIT kitBehavioural
Receive a standard FIT kit
Enhanced FIT kitBehavioural
Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device
Telephone patient navigationBehavioural
Receive telephone-based patient navigation
Text message patient navigationBehavioural
Receive text message-based patient navigation
| Study group | Role | What they receive |
|---|---|---|
| Group A (standard FIT kit plus telephone PN) | Experimental | Participants receive standard FIT kit plus telephone patient navigation (PN) Receives: Behavioral: Standard FIT kit; Behavioral: Telephone patient navigation |
| Group B (standard FIT kit plus text message PN) | Experimental | Participants receive standard FIT kit plus text message patient navigation (PN) Receives: Behavioral: Standard FIT kit; Behavioral: Text message patient navigation |
| Group C (enhanced FIT kit plus telephone PN) | Experimental | Participants receive enhanced FIT kit plus telephone patient navigation (PN) Receives: Behavioral: Enhanced FIT kit; Behavioral: Telephone patient navigation |
| Group D (enhanced FIT kit plus text message PN) | Experimental | Participants receive enhanced FIT kit plus text message patient navigation (PN) Receives: Behavioral: Enhanced FIT kit; Behavioral: Text message patient navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIT Return
Proportion of participants who return of a completed FIT kit
Measured: Within 8 weeks of FIT kit distribution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start20 Jan 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Paul Reiter, Ohio State University Comprehensive Cancer Center
- Investigators
- Paul Reiter, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173985
- Sponsor's protocol ID
- OSU-24377
- Other IDs
- R01CA282162
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Optimizing a Mailed FIT Program in Appalachia
- ClinicalTrials.gov ID
- NCT07173985
- Acronym / sponsor ID
- OSU-24377
- Conditions
- Colonic Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 15 Sep 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.
The proposed study is examining strategies for optimizing mailed fecal immunochemical test (FIT) programs. In doing so, it will assess the efficacy of two promising strategies, FIT kit materials and patient navigation delivery mode. These strategies may help to improve colorectal cancer screening rates.
Detailed description
PRIMARY OBJECTIVES:
Determine the efficacy of two strategies for increasing colorectal cancer screening.
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I: Participants receive a standard FIT kit plus telephone patient navigation.
GROUP II: Participants receive a standard FIT kit plus text message patient navigation.
GROUP III: Participants receive an enhanced FIT kit plus telephone patient navigation.
GROUP IV: Participants receive an enhanced FIT kit plus text message patient navigation.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (standard FIT kit plus telephone PN) | Experimental | Behavioral: Standard FIT kit, Behavioral: Telephone patient navigationParticipants receive standard FIT kit plus telephone patient navigation (PN) |
| Group B (standard FIT kit plus text message PN) | Experimental | Behavioral: Standard FIT kit, Behavioral: Text message patient navigationParticipants receive standard FIT kit plus text message patient navigation (PN) |
| Group C (enhanced FIT kit plus telephone PN) | Experimental | Behavioral: Enhanced FIT kit, Behavioral: Telephone patient navigationParticipants receive enhanced FIT kit plus telephone patient navigation (PN) |
| Group D (enhanced FIT kit plus text message PN) | Experimental | Behavioral: Enhanced FIT kit, Behavioral: Text message patient navigationParticipants receive enhanced FIT kit plus text message patient navigation (PN) |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resident of an Appalachian county
- Medical visit at a participating health system in the past two years
- Average-risk for colorectal cancer
- Not currently within colorectal cancer screening guidelines
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Standard FIT kitReceive a standard FIT kit | Behavioural | Group A (standard FIT kit plus telephone PN), Group B (standard FIT kit plus text message PN) |
| Enhanced FIT kitReceive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device | Behavioural | Group C (enhanced FIT kit plus telephone PN), Group D (enhanced FIT kit plus text message PN) |
| Telephone patient navigationReceive telephone-based patient navigation | Behavioural | Group A (standard FIT kit plus telephone PN), Group C (enhanced FIT kit plus telephone PN) |
| Text message patient navigationReceive text message-based patient navigation | Behavioural | Group B (standard FIT kit plus text message PN), Group D (enhanced FIT kit plus text message PN) |
Primary outcome
FIT Return
Time frame: Within 8 weeks of FIT kit distribution
Proportion of participants who return of a completed FIT kit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- The JameslineLink provided by the sponsor.
- 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.
Ohio State University Comprehensive Cancer Center
Columbus, United States
Paul Reiter, PhD principal investigator
Ohio State University Comprehensive Cancer 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 Standard FIT kit, Enhanced FIT kit and Telephone patient navigation in people with Colonic Neoplasms, run by Ohio State University Comprehensive Cancer 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIT Return (time frame: Within 8 weeks of FIT kit distribution). 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 9 Jul 2026.