Trial Outcomes & Findings for Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion (NCT NCT03598166)
NCT ID: NCT03598166
Last Updated: 2023-01-05
Results Overview
Percentage of participants who undergo screening in the intervention group vs. control group, measured 6 months after the initial letter was sent
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
359 participants
Primary outcome timeframe
6 months
Results posted on
2023-01-05
Participant Flow
The target enrollment specified in the protocol is 360 participants. Actual enrollment was 359 participants.
Participant milestones
| Measure |
Control
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter.
Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.
|
Septin9
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.
Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.
Septin9: Septin9 is a FDA-approved blood test for colorectal cancer screening
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
181
|
|
Overall Study
COMPLETED
|
178
|
181
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
Baseline characteristics by cohort
| Measure |
Control
n=178 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter.
Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.
|
Septin9
n=181 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.
Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.
Septin9: Septin9 is a FDA-approved blood test for colorectal cancer screening
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=178 Participants
|
0 Participants
n=181 Participants
|
0 Participants
n=359 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=178 Participants
|
87 Participants
n=181 Participants
|
163 Participants
n=359 Participants
|
|
Age, Categorical
>=65 years
|
102 Participants
n=178 Participants
|
94 Participants
n=181 Participants
|
196 Participants
n=359 Participants
|
|
Age, Continuous
|
67 Years
n=178 Participants
|
66 Years
n=181 Participants
|
66 Years
n=359 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=178 Participants
|
9 Participants
n=181 Participants
|
16 Participants
n=359 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=178 Participants
|
172 Participants
n=181 Participants
|
343 Participants
n=359 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=178 Participants
|
29 Participants
n=181 Participants
|
55 Participants
n=359 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
151 Participants
n=178 Participants
|
147 Participants
n=181 Participants
|
298 Participants
n=359 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=178 Participants
|
5 Participants
n=181 Participants
|
6 Participants
n=359 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
1 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
1 Participants
n=304 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
2 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
5 Participants
n=304 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
1 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
2 Participants
n=304 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
|
Race (NIH/OMB)
Black or African American
|
70 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
77 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
147 Participants
n=304 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
|
Race (NIH/OMB)
White
|
68 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
62 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
130 Participants
n=304 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
0 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
0 Participants
n=304 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
9 Participants
n=152 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
19 Participants
n=304 Participants • The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.
|
|
Region of Enrollment
United States
|
178 participants
n=178 Participants
|
181 participants
n=181 Participants
|
359 participants
n=359 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of participants who undergo screening in the intervention group vs. control group, measured 6 months after the initial letter was sent
Outcome measures
| Measure |
Control
n=178 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter.
Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.
|
Septin9
n=181 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.
Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.
Septin9: Septin9 is a FDA-approved blood test for colorectal cancer screening
|
Accustomed to Blood Tests
Patients are willing to do a blood test for colorectal cancer screening because they feel accustomed to blood draw tests.
|
|---|---|---|---|
|
Percentage of Participants Who Undergo Screening Within 6 Months of Outreach
|
17 Participants
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsComplete screening in both groups, which is defined as completion of the entire screening strategy. For colonoscopy, this requires cecal intubation and an adequate bowel preparation. For individuals who took Septin9 and FIT, positive results must be followed by a colonoscopy with cecal intubation and adequate bowel preparation.
Outcome measures
| Measure |
Control
n=178 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter.
Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.
|
Septin9
n=181 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.
Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.
Septin9: Septin9 is a FDA-approved blood test for colorectal cancer screening
|
Accustomed to Blood Tests
Patients are willing to do a blood test for colorectal cancer screening because they feel accustomed to blood draw tests.
|
|---|---|---|---|
|
Percentage of Participants Completing Screening Strategy
|
16 Participants
|
27 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 months (after positive FIT)Population: The overall number of participants analyzed corresponds to the number of participants with a positive FIT.
Among individuals in the intervention group who had a positive blood test, proportion who completed a follow-up colonoscopy within 6 months.
Outcome measures
| Measure |
Control
n=2 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter.
Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.
|
Septin9
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.
Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.
Septin9: Septin9 is a FDA-approved blood test for colorectal cancer screening
|
Accustomed to Blood Tests
Patients are willing to do a blood test for colorectal cancer screening because they feel accustomed to blood draw tests.
|
|---|---|---|---|
|
Percentage of Participants With Colonoscopy Follow-up in Intervention Group
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 day (assessed using baseline survey)Population: The same survey was sent to all participants. The planned analysis was to include all participants who returned the survey, rather than stratified by arm.
Percentage of both groups who answered that they would be willing to take a blood test for colorectal cancer screening
Outcome measures
| Measure |
Control
n=76 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter.
Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.
|
Septin9
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.
Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.
Septin9: Septin9 is a FDA-approved blood test for colorectal cancer screening
|
Accustomed to Blood Tests
Patients are willing to do a blood test for colorectal cancer screening because they feel accustomed to blood draw tests.
|
|---|---|---|---|
|
Self-reported Willingness to Take Blood Test for Colorectal Cancer Screening on Questionnaire
|
65 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 day (assessed using baseline survey)Population: The same survey was sent to all participants. The planned analysis was to include all participants who returned the survey, rather than stratified by arm.
The most commonly cited advantages of a blood test compared to colonoscopy and stool test in both groups
Outcome measures
| Measure |
Control
n=76 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter.
Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.
|
Septin9
n=76 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.
Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.
Septin9: Septin9 is a FDA-approved blood test for colorectal cancer screening
|
Accustomed to Blood Tests
n=61 Participants
Patients are willing to do a blood test for colorectal cancer screening because they feel accustomed to blood draw tests.
|
|---|---|---|---|
|
Self-reported Most Common Advantages of Blood Test on Questionnaire
|
46 Participants
|
31 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 1 day (assessed using baseline survey)Population: The overall number of participants who indicated that they would refuse a blood test on the questionnaire.
The most commonly cited reasons for not taking the blood test in the intervention group.
Outcome measures
| Measure |
Control
n=9 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter.
Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.
|
Septin9
n=9 Participants
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.
Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.
Septin9: Septin9 is a FDA-approved blood test for colorectal cancer screening
|
Accustomed to Blood Tests
Patients are willing to do a blood test for colorectal cancer screening because they feel accustomed to blood draw tests.
|
|---|---|---|---|
|
Self-reported Most Common Reasons for Refusing Blood Test on Questionnaire in Intervention Group
|
4 Participants
|
3 Participants
|
—
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Septin9
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place