Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Breast Carcinoma 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
• 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
• 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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Colon Carcinoma
• Malignant Solid Neoplasm
• Ovarian Carcinoma
• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Prostate Carcinoma

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)