Colorectal Cancer
Conditions
Brief 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.
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.
Interventions
BEHAVIORALProactive CRC Screening Outreach
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.
BEHAVIORALUsual Care
Participants will not receive additional outreach from the study team regarding CRC screening.
Sponsors
National Cancer Institute (NCI)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Receiving medical care at Flatbush FHC * Due or overdue for CRC screening
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months | 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 | Up to Month 6 | Number of Participants who underwent colonoscopy by 6 months past the start of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months | Up to Month 6 | Number of Participants who underwent colonoscopy after a positive FIT result by 6 months past the start of intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proactive Screening Outreach 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.
Proactive CRC Screening Outreach: 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. | 50 |
| Usual Care Individuals in the usual care group will not be approached or notified of their enrollment in the study.
Usual Care: Participants will not receive additional outreach from the study team regarding CRC screening. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | no longer screen eligible (completed screening prior to intervention) | 6 | 0 |
| Overall Study | translated materials not available for pilot | 2 | 0 |
Baseline characteristics
| Characteristic | Proactive Screening Outreach | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 55.54 years STANDARD_DEVIATION 8.53 | 55.47 years STANDARD_DEVIATION 8.43 | 55.40 years STANDARD_DEVIATION 8.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 94 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 90 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 50 Participants | 100 Participants | 50 Participants |
| Sex: Female, Male Female | 36 Participants | 74 Participants | 38 Participants |
| Sex: Female, Male Male | 14 Participants | 26 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proactive Screening Outreach | Number of Participants Who Completed Colonoscopy at 6 Months | 4 Participants |
| Usual Care | Number of Participants Who Completed Colonoscopy at 6 Months | 1 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proactive Screening Outreach | Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months | 7 Participants |
| Usual Care | Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proactive Screening Outreach | Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months | 0 Participants |
| Usual Care | Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months | 0 Participants |