Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Not Applicable

Completed

• Conditions: Breast Carcinoma; Colon Carcinoma; Malignant Solid Neoplasm; Prostate Carcinoma; Ovarian Carcinoma; Pancreatic Carcinoma
• Interventions: Other: Electronic Health Record Review; Other: Questionnaire Administration; Behavioral: Behavioral Intervention

• Registration Number: NCT04902144
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Study Timeline

• Study Start: 2020-08-03
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-26
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Results First Submitted: 2022-12-18
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-13
• Last Update Submitted: 2023-05-13
• Results First Posted: 2023-06-09
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (medical records, coaching)	Electronic Health Record Review	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 providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.
Screening (medical records, coaching)	Questionnaire Administration	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 providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.
Screening (medical records, coaching)	Behavioral Intervention	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 providers receive coaching from SCCA subject matter experts for guidance on providing genetic counseling and testing to their patients.

Primary Outcome Measures

Name	Time	Method
Clinical and Patient Reported Outcomes Following Genetic Test Results	Up to study completion (Assessed up to 1 year and 4 months)	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
Uptake of Genetic Testing	Up to study completion (Assessed up to1 year and 4 months)	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.
Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing	6 months	The number of cancer patients who meet criteria for genetic counseling and testing as identified by the study team and OMC oncology providers

Trial Locations

Locations (1)

Olympic Medical Cancer Center; 🇺🇸 Sequim, Washington, United States