Trial Outcomes & Findings for Impact of Family History and Decision Support on High-risk Cancer Screening (NCT NCT02247336)
NCT ID: NCT02247336
Last Updated: 2023-07-27
Results Overview
Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
505 participants
Primary outcome timeframe
12 months
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Immediate
Patients will complete MeTree at enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
Delayed
Patients will complete MeTree 12 months following enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
|---|---|---|
|
Overall Study
STARTED
|
252
|
253
|
|
Overall Study
COMPLETED
|
252
|
253
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Family History and Decision Support on High-risk Cancer Screening
Baseline characteristics by cohort
| Measure |
Immediate
n=252 Participants
Patients will complete MeTree at enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
Delayed
n=253 Participants
Patients will complete MeTree 12 months following enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
Total
n=505 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
196 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
242 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
482 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
156 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ever had a colonoscopy or sigmoidoscopy
|
101 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis sample is the number of patients who completed the family health history assessment, as risk level was necessary to determine risk-appropriate referrals.
Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.
Outcome measures
| Measure |
Immediate
n=252 Participants
Patients will complete MeTree at enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
Delayed
n=253 Participants
Patients will complete MeTree 12 months following enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
|---|---|---|
|
Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
|
219 Participants
|
232 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analytic sample is participants who had a referral for colorectal cancer screening
Among patients who received a referral, the percentage who received recommended colorectal cancer screening.
Outcome measures
| Measure |
Immediate
n=103 Participants
Patients will complete MeTree at enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
Delayed
n=109 Participants
Patients will complete MeTree 12 months following enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
|---|---|---|
|
Number of Participants Who Received Recommended Colorectal Cancer Screening
|
55 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Subgroup of veterans who received a recommendation for genetic counseling from the family health history platform
Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation.
Outcome measures
| Measure |
Immediate
n=22 Participants
Patients will complete MeTree at enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
Delayed
n=15 Participants
Patients will complete MeTree 12 months following enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree
|
|---|---|---|
|
Number of Patients Who Received Referral for Genetic Consultation
|
1 Participants
|
1 Participants
|
Adverse Events
Immediate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Delayed
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
Corrine Voils, PhD
William S Middleton Memorial Veterans Hospital
Phone: 608-256-1901
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place