Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

May 13, 2023 updated by: Marianne Dubard-Gault, Fred Hutchinson Cancer Center

Breast and Ovarian Catchment Pilot Grant: Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Sequim, Washington, United States, 98382
        • Olympic Medical Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening (medical records, coaching)

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.
Other: Questionnaire Administration
Complete questionnaires
Other: Electronic Health Record Review
Medical data collected
Behavioral: Behavioral Intervention
Receive coaching
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing
Time Frame: 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
6 months
Uptake of Genetic Testing
Time Frame: 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.
Up to study completion (Assessed up to1 year and 4 months)
Clinical and Patient Reported Outcomes Following Genetic Test Results
Time Frame: 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
Up to study completion (Assessed up to 1 year and 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Marianne Dubard-Gault, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

May 13, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1121550
  • P30CA015704 (U.S. NIH Grant/Contract)
  • NCI-2021-04181 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • STUDY00010137 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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