Clinical trial NCT04902144: Clinical Outcomes for Offering Genetic Testing in a Tiered Approach
Official title: Breast and Ovarian Catchment Pilot Grant: Clinical Outcomes for Offering Genetic Testing in a Tiered Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Colon Carcinoma
Malignant Solid Neoplasm
Ovarian Carcinoma
Pancreatic Carcinoma
Prostate Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-26
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing
timeFrame: 6 months
measure: Uptake of Genetic Testing
timeFrame: Up to study completion (Assessed up to1 year and 4 months)
measure: Clinical and Patient Reported Outcomes Following Genetic Test Results
timeFrame: Up to study completion (Assessed up to 1 year and 4 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Sequim
country: United States
facility: Olympic Medical Cancer Center
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Marianne Dubard-Gault
role: PRINCIPAL_INVESTIGATOR
References: