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Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Primary Purpose

Breast Carcinoma, Colon Carcinoma, Malignant Solid Neoplasm

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electronic Health Record Review

Questionnaire Administration

Behavioral Intervention

About this trial

This is an interventional screening trial for Breast Carcinoma

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Medical oncology providers at OMC who see patients with an active diagnosis of breast, ovarian, prostate, colon, or pancreatic cancer
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
Patients who are minors
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)

Sites / Locations

Olympic Medical Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (medical records, coaching)

Arm 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.

Outcomes

Primary Outcome Measures

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

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04902144

First Posted

May 17, 2021

Last Updated

May 13, 2023

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04902144

Brief Title

Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

August 3, 2020 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Carcinoma, Colon Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Screening (medical records, coaching)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Electronic Health Record Review

Intervention Description

Medical data collected

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Complete questionnaires

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Intervention

Other Intervention Name(s)

Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Intervention Description

Receive coaching

Primary Outcome Measure Information:

Title

Identify Cancer Patients Who Meet Criteria for Genetic Counseling and Testing

Description

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

Title

Uptake of Genetic Testing

Description

Time Frame

Up to study completion (Assessed up to1 year and 4 months)

Title

Clinical and Patient Reported Outcomes Following Genetic Test Results

Description

Time Frame

Up to study completion (Assessed up to 1 year and 4 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianne Dubard-Gault

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Olympic Medical Cancer Center

City

Sequim

State/Province

Washington

ZIP/Postal Code

98382

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

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