Trial Outcomes & Findings for Clinical Outcomes for Offering Genetic Testing in a Tiered Approach (NCT NCT04902144)
NCT ID: NCT04902144
Last Updated: 2023-06-09
Results Overview
The number of cancer patients who meet criteria for genetic counseling and testing as identified by the study team and OMC oncology providers
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-09
Participant Flow
Participant milestones
| Measure |
Medical Data Collection, Peer Coaching
PHASE I: Patients' medical data are collected,
PHASE II: Olympic Medical Center (OMC) patients complete family history questionnaires and their medical data are collected. Seattle Cancer Care Alliance (SCCA) subject matter experts and OMC providers review patients' medical data at bi-weekly virtual conferences. OMC providers will be consenting to release their patients' medical records to SCCA so that SCCA subject matter experts (cancer geneticist and/or genetic counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling and testing.
OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.
Electronic Health Record Review: Medical data collected
Questionnaire Administration: Complete questionnaires
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Outcomes for Offering Genetic Testing in a Tiered Approach
Baseline characteristics by cohort
| Measure |
Medical Data Collection, Peer Coaching
n=6 Participants
PHASE I: Patients' medical data are collected,
PHASE II: Olympic Medical Center (OMC) patients complete family history questionnaires and their medical data are collected. Seattle Cancer Care Alliance (SCCA) subject matter experts and OMC providers review patients' medical data at bi-weekly virtual conferences. OMC providers will be consenting to release their patients' medical records to SCCA so that SCCA subject matter experts (cancer geneticist and/or genetic counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling and testing.
OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.
Electronic Health Record Review: Medical data collected
Questionnaire Administration: Complete questionnaires
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe number of cancer patients who meet criteria for genetic counseling and testing as identified by the study team and OMC oncology providers
Outcome measures
| Measure |
Medical Data Collection Without Peer Coaching
n=6 Participants
PHASE I: Medical oncologists enrolled, Patients' medical data are collected but were not enrolled.
|
Medical Data Collection With Peer Coaching
n=6 Participants
PHASE II: Olympic Medical Center (OMC) patients complete family history questionnaires and their medical data are collected, they were not enrolled. medical oncologists seeing them were enrolled as participants. Seattle Cancer Care Alliance (SCCA) subject matter experts and OMC providers review patients' medical data at bi-weekly virtual conferences. OMC providers will be consenting to release their patients' medical records to SCCA so that SCCA subject matter experts (cancer geneticist and/or genetic counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling and testing.
OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.
Electronic Health Record Review: Medical data collected Questionnaire Administration: Complete questionnaires
|
|---|---|---|
|
Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing
|
100 patients
|
48 patients
|
PRIMARY outcome
Timeframe: Up to study completion (Assessed up to1 year and 4 months)Population: The number of genetic testing kits ordered and processed for patients with cancer who meet criteria for testing in phase I and phase II
Number of genetic testing ordered and processed for patients with cancer who meet criteria for testing. Out of 415 patients seen in phase I, 100 met criteria but only 29 received testing. Out of 219 patients seen in phase II, 48 met criteria but only 25 received testing.
Outcome measures
| Measure |
Medical Data Collection Without Peer Coaching
n=415 Participants
PHASE I: Medical oncologists enrolled, Patients' medical data are collected but were not enrolled.
|
Medical Data Collection With Peer Coaching
n=219 Participants
PHASE II: Olympic Medical Center (OMC) patients complete family history questionnaires and their medical data are collected, they were not enrolled. medical oncologists seeing them were enrolled as participants. Seattle Cancer Care Alliance (SCCA) subject matter experts and OMC providers review patients' medical data at bi-weekly virtual conferences. OMC providers will be consenting to release their patients' medical records to SCCA so that SCCA subject matter experts (cancer geneticist and/or genetic counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling and testing.
OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.
Electronic Health Record Review: Medical data collected Questionnaire Administration: Complete questionnaires
|
|---|---|---|
|
Uptake of Genetic Testing
|
29 tests
|
25 tests
|
PRIMARY outcome
Timeframe: Up to study completion (Assessed up to 1 year and 4 months)Population: 5 patients were referred to our center for post test counseling and treatment recommendations in the setting of positive results. Many other patients could have chosen to go to a cancer genetic clinic closer to their home.
Pertinent clinical information regarding genetic test result and related outcomes (referrals, treatment recommendations); pulled directly from electronic health record, genetic test reports, and patient questionnaires
Outcome measures
| Measure |
Medical Data Collection Without Peer Coaching
n=415 Participants
PHASE I: Medical oncologists enrolled, Patients' medical data are collected but were not enrolled.
|
Medical Data Collection With Peer Coaching
n=219 Participants
PHASE II: Olympic Medical Center (OMC) patients complete family history questionnaires and their medical data are collected, they were not enrolled. medical oncologists seeing them were enrolled as participants. Seattle Cancer Care Alliance (SCCA) subject matter experts and OMC providers review patients' medical data at bi-weekly virtual conferences. OMC providers will be consenting to release their patients' medical records to SCCA so that SCCA subject matter experts (cancer geneticist and/or genetic counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling and testing.
OMC providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.
Electronic Health Record Review: Medical data collected Questionnaire Administration: Complete questionnaires
|
|---|---|---|
|
Clinical and Patient Reported Outcomes Following Genetic Test Results
|
2 Participants
|
3 Participants
|
Adverse Events
Screening (Medical Records, Coaching)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place