Trial Outcomes & Findings for Reducing Colorectal Cancer Death Through Mailed Outreach Screening (NCT NCT02584998)

Last Updated: 2018-12-24

Results Overview

The completion rate of mailed FIT test within 6 months of the mailing of the screening invitation. The absence of FIT result in the electronic medical record (CRPS) will be considered a failure to complete the FIT test

Recruitment status

COMPLETED

Study phase

Target enrollment

782 participants

Primary outcome timeframe

6 months

Results posted on

2018-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.	Screening Invitation-reminder Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero). Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm	Mailed-FIT Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero). Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample.
Overall Study STARTED	260	261	261
Overall Study COMPLETED	260	261	261
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Colorectal Cancer Death Through Mailed Outreach Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=260 Participants These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.	Screening Invitation-reminder n=261 Participants Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero). Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm	Mailed-FIT n=261 Participants Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero). Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample.	Total n=782 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 7.0 • n=5 Participants	60 years STANDARD_DEVIATION 7.0 • n=7 Participants	61 years STANDARD_DEVIATION 6.5 • n=5 Participants	61 years STANDARD_DEVIATION 6.8 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	252 Participants n=5 Participants	254 Participants n=7 Participants	254 Participants n=5 Participants	760 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black	162 Participants n=5 Participants	149 Participants n=7 Participants	160 Participants n=5 Participants	471 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	85 Participants n=5 Participants	97 Participants n=7 Participants	88 Participants n=5 Participants	270 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized Race · Unknown	10 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment United States	260 Participants n=5 Participants	261 Participants n=7 Participants	261 Participants n=5 Participants	782 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: For this outcome, we just analyzed patients in Arm 3 (n=261), the mailed-FIT kit, arm, as they were the only patients eligible to return a mailed fit kit.

Outcome measures

Outcome measures
Measure	Usual Care These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.	Screening Invitation-reminder Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero). Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm	Mailed-FIT n=261 Participants Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero). Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample.
The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months	0 Participants	0 Participants	62 Participants

SECONDARY outcome

Timeframe: 6 months

Population: We analyzed all randomized patients to identify any CRC screening at 6 months from mailed screening invitation.

The receipt of any colorectal cancer screening test in the 6-month period after enrollment into the study. For patients in the usual care arm, 6 months was counted from the date of mailed letter to arms 2 and 3 within that block of participants.

Outcome measures

Outcome measures
Measure	Usual Care n=260 Participants These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.	Screening Invitation-reminder n=261 Participants Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero). Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm	Mailed-FIT n=261 Participants Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero). Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample.
The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study.	15 Participants	20 Participants	68 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Screening Invitation-reminder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mailed-FIT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emily Carter Paulson, MD MSCA

CMC VAMC

Phone: 215-823-5880

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place