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NCT04902144 Clinical Trial

Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Malignant Solid Neoplasm Clinical Trial

Official title:
Breast and Ovarian Catchment Pilot Grant: Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04902144
Other study ID # RG1121550
Secondary ID NCI-2021-04181ST
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2020
Est. completion date December 31, 2021

Study information
Verified date May 2023
Source Fred Hutchinson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 90 Years
Eligibility Inclusion Criteria: - Medical oncology providers at OMC who see patients with an active diagnosis of breast, ovarian, prostate, colon, or pancreatic cancer Exclusion Criteria: - OMC providers who do not see patients with an active diagnosis of cancer - OMC providers who see patients who are minors - OMC providers who see patients with precancerous lesions such as ductal carcinoma in situ (the presence of abnormal cells inside a milk duct in the breast) or colon polyps (a small clump of cells that form on the lining of the colon or rectum)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Electronic Health Record Review
Medical data collected
• Questionnaire Administration
Complete questionnaires
Behavioral:
• Behavioral Intervention
Receive coaching

Locations
Country Name City State
United States Olympic Medical Cancer Center Sequim Washington

Sponsors (2)
Lead Sponsor Collaborator
Fred Hutchinson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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)
Primary 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)
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