An interventional study of Proactive CRC Screening Outreach and Usual Care in Colorectal Cancer, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Screening
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 109 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Proactive CRC Screening Outreach
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
Behavioral: Usual Care
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.
Participants will not receive additional outreach from the study team regarding CRC screening.
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
Time frame: 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
Time frame: Up to Month 6
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
Time frame: Up to Month 6
| Milestone | Proactive Screening Outreach | Usual Care |
|---|---|---|
| Started | 59 | 50 |
| Completed | 50 | 50 |
| Not completed | 9 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Translated materials not available for pilot | 2 | 0 |
| Withdrew: No longer screen eligible (completed screening prior to intervention) | 6 | 0 |
Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention
| Participants | Proactive Screening Outreach | Usual Care |
|---|---|---|
| Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months | 7 | 0 |
Number of Participants who underwent colonoscopy by 6 months past the start of intervention
| Participants | Proactive Screening Outreach | Usual Care |
|---|---|---|
| Number of Participants Who Completed Colonoscopy at 6 Months | 4 | 1 |
Number of Participants who underwent colonoscopy after a positive FIT result by 6 months past the start of intervention
| Participants | Proactive Screening Outreach | Usual Care |
|---|---|---|
| Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months | 0 | 0 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proactive Screening Outreach | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Usual Care | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | Proactive Screening Outreach | Usual Care | Total |
|---|---|---|---|
| Mean | 55.54 ± 8.53 | 55.40 ± 8.42 | 55.47 ± 8.43 |
| Sex: Female, Male(Participants) | Proactive Screening Outreach | Usual Care | Total |
|---|---|---|---|
| Female | 36 | 38 | 74 |
| Male | 14 | 12 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Proactive Screening Outreach | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 47 | 47 | 94 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Proactive Screening Outreach | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 4 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 45 | 45 | 90 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Proactive Screening Outreach | Usual Care | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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