Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Prostate Carcinoma; Colon Carcinoma; Ovarian Carcinoma; Malignant Solid Neoplasm; Breast Carcinoma; Pancreatic Carcinoma

Treatments: Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04902144

RG1121550

NCI-2021-04181 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

STUDY00010137 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Screening (medical records, coaching)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Electronic Health Record Review

Behavioral: Behavioral Intervention