Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Other: Electronic Health Record Review. Medical data collected

Intervention public domain (ClinicalTrials.gov)

Other: Questionnaire Administration. Complete questionnaires

Intervention public domain (ClinicalTrials.gov)

Behavioral: Behavioral Intervention. Receive coaching

Arm public domain (ClinicalTrials.gov)

Screening (medical records, coaching) (experimental): 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 public domain (ClinicalTrials.gov)

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 Time frame: 6 months.

Primary outcome public domain (ClinicalTrials.gov)

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. Time frame: Up to study completion (Assessed up to1 year and 4 months).

Primary outcome public domain (ClinicalTrials.gov)

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 Time frame: Up to study completion (Assessed up to 1 year and 4 months).

Eligibility public domain (ClinicalTrials.gov)

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)

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 6 participants (actual).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing [6 months]. Number, patients. Medical Data Collection Without Peer Coaching (n=6): 100; Medical Data Collection With Peer Coaching (n=6): 48.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Uptake of Genetic Testing [Up to study completion (Assessed up to1 year and 4 months)]. Number, tests. Medical Data Collection Without Peer Coaching (n=415): 29; Medical Data Collection With Peer Coaching (n=219): 25.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Clinical and Patient Reported Outcomes Following Genetic Test Results [Up to study completion (Assessed up to 1 year and 4 months)]. Count Of Participants, Participants. Medical Data Collection Without Peer Coaching (n=415): 2; Medical Data Collection With Peer Coaching (n=219): 3.