Colorectal CancerNCT05646355
Flatbush FHC Proactive Colorectal Cancer Screening and Navigation
A study testing Proactive CRC Screening Outreach in people with Colorectal Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Proactive CRC Screening Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receiving medical care at Flatbush FHC
- Due or overdue for CRC screening
Who cannot join
- Age younger than 45 years old or greater than 75 years old
- Up-to-date with colorectal cancer screening (FIT within 1 year or colonoscopy within 10 years)
- History of colorectal cancer, inflammatory bowel disease or colorectal polyps
- No address or phone number on file
- FIT test ordered within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Brooklyn Family Health Centers
Brooklyn, New York, 11220
About this study
Official title: Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn
The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice.
Read the detailed description
The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice, which provides free and subsidized health services to underrepresented minorities. The investigators will randomize patients to the proactive screening outreach arm which will include mailed letters providing patients with information regarding their eligibility for and instructions for performing colorectal cancer screening with FIT testing or colonoscopy. Colorectal cancer screening rates via FIT testing or colonoscopy will be compared in the proactive outreach group and the usual care group. The investigators hypothesize that rates of colorectal cancer screening will improve in underserved populations with the implementation of a proactive approach that incorporates a mailed outreach invitation to screen, followed by active assistance to a colonoscopy completion if preferred or indicated.
- Conditions
- Colorectal Cancer
- Being tested
- Proactive CRC Screening Outreach, Usual Care
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive CRC Screening OutreachBehavioural
Proactive approach that incorporates a mailed outreach invitation to screen with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy completion if preferred or indicated by FIT test result.
Usual CareBehavioural
Participants will not receive additional outreach from the study team regarding CRC screening.
| Study group | Role | What they receive |
|---|---|---|
| Proactive Screening Outreach | Experimental | Participants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference.
Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed.
If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit. Receives: Behavioral: Proactive CRC Screening Outreach |
| Usual Care | Active comparator | Individuals in the usual care group will not be approached or notified of their enrollment in the study. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months
Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention
Measured: Up to Month 6
Number of Participants Who Completed Colonoscopy at 6 Months
Number of Participants who underwent colonoscopy by 6 months past the start of intervention
Measured: Up to Month 6
Secondary outcomes (1)
Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months
Number of Participants who underwent colonoscopy after a positive FIT result by 6 months past the start of intervention
Measured: Up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start15 Mar 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aasma Shaukat, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646355
- Sponsor's protocol ID
- 22-00730
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2022
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Aasma.Shaukat@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn
- ClinicalTrials.gov ID
- NCT05646355
- Acronym / sponsor ID
- 22-00730
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Posted 27 Dec 2024
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 a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice.
Detailed description
The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice, which provides free and subsidized health services to underrepresented minorities. The investigators will randomize patients to the proactive screening outreach arm which will include mailed letters providing patients with information regarding their eligibility for and instructions for performing colorectal cancer screening with FIT testing or colonoscopy. Colorectal cancer screening rates via FIT testing or colonoscopy will be compared in the proactive outreach group and the usual care group. The investigators hypothesize that rates of colorectal cancer screening will improve in underserved populations with the implementation of a proactive approach that incorporates a mailed outreach invitation to screen, followed by active assistance to a colonoscopy completion if preferred or indicated.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive Screening Outreach | Experimental | Behavioral: Proactive CRC Screening OutreachParticipants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference. Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed. If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit. |
| Usual Care | Active comparator | Behavioral: Usual CareIndividuals in the usual care group will not be approached or notified of their enrollment in the study. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving medical care at Flatbush FHC
- Due or overdue for CRC screening
Key exclusion criteria (5 listed)
- Age younger than 45 years old or greater than 75 years old
- Up-to-date with colorectal cancer screening (FIT within 1 year or colonoscopy within 10 years)
- History of colorectal cancer, inflammatory bowel disease or colorectal polyps
- No address or phone number on file
- FIT test ordered within 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 |
|---|---|---|
| Proactive CRC Screening OutreachProactive approach that incorporates a mailed outreach invitation to screen with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy completion if preferred or indicated by FIT test result. | Behavioural | Proactive Screening Outreach |
| Usual CareParticipants will not receive additional outreach from the study team regarding CRC screening. | Behavioural | Usual Care |
Primary outcome
Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months
Time frame: Up to Month 6
Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention
Number of Participants Who Completed Colonoscopy at 6 Months
Time frame: Up to Month 6
Number of Participants who underwent colonoscopy by 6 months past the start of intervention
1 secondary outcome
Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months
Time frame: Up to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Aasma.Shaukat@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Aasma Shaukat principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive CRC Screening Outreach in people with Colorectal Cancer, run by NYU Langone Health 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 5 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 27 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months (time frame: Up to Month 6). The study lists 2 primary outcomes in all. 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 27 Dec 2024.