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2020-08-03
2021-12-31
2021-12-31
6
NCT04902144
Fred Hutchinson Cancer Center
Fred Hutchinson Cancer Center
INTERVENTIONAL
Clinical Outcomes for Offering Genetic Testing in a Tiered Approach
This clinical quality improvement study reviews and develops a clinical operations workflow to identify cancer patients who meet criteria for genetic counseling and testing. This study may improve utilization of genetic counseling and testing amongst community-based oncology providers caring for cancer patients in a rural and underserved area.
OUTLINE: Medical oncologists at Olympic Medical Center (OMC) participated in this study and received a peer coaching intervention during phase II to help identify patients who meet criteria for genetic counseling and testing PHASE I: Patients' medical data are collected; no intervention. 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-05-17 | 2022-12-18 | 2023-05-13 |
2021-05-20 | 2023-05-13 | 2023-06-09 |
2021-05-26 | 2023-06-09 | 2023-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Screening
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Screening (medical records, coaching) PHASE I: Patients' medical data are collected. PHASE II: Patients complete questionnaires and their medical data is collected. SCCA subject matter experts and OMC providers review patients' medical data at bi-monthly virtual conferences. OMC pr | OTHER: Electronic Health Record Review
OTHER: Questionnaire Administration
BEHAVIORAL: Behavioral Intervention
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing | The number of cancer patients who meet criteria for genetic counseling and testing as identified by the study team and OMC oncology providers | 6 months |
| Uptake of Genetic Testing | 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. | Up to study completion (Assessed up to1 year and 4 months) |
| Clinical and Patient Reported Outcomes Following Genetic Test Results | 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 | Up to study completion (Assessed up to 1 year and 4 months) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
