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Clinical Outcomes for Offering Genetic Testing in a Tiered Approach

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT04902144
Collaborator
National Cancer Institute (NCI) (NIH)
6
Enrollment
1
Location
1
Arm
16.9
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial 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 providers caring for cancer patients in a rural and underserved area.

Condition or Disease Intervention/Treatment Phase
  • Other: Electronic Health Record Review
  • Other: Questionnaire Administration
  • Behavioral: Behavioral Intervention
 N/A

Detailed Description

OUTLINE:

PHASE I: Patients' medical data are collected.

PHASE II: 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-monthly 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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Breast and Ovarian Catchment Pilot Grant: Clinical Outcomes for Offering Genetic Testing in a Tiered Approach
Actual Study Start Date :
Aug 3, 2020
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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: Electronic Health Record Review
Medical data collected

Other: Questionnaire Administration
Complete questionnaires

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Identify cancer patients who meet criteria for genetic counseling and testing [Up to study completion (Assessed up to 2 years)]

      The number of cancer patients who meet for genetic counseling and testing as identified by the study team and OMC oncology providers

    2. Uptake of genetic testing [Up to study completion (Assessed up to 2 years)]

      The number of genetic testing kits ordered and processed for cancer patients who meet criteria

    3. Clinical and patient reported outcomes following genetic test results [Up to study completion (Assessed up to 2 years)]

      Pertinent clinical information regarding genetic test result and related outcomes (referrals, treatment recommendations); pulled directly from EHR, genetic test reports, and patient questionnaires

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Olympic Medical Cancer Center Sequim Washington United States 98382

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04902144
    Other Study ID Numbers:
    • RG1121550
    • NCI-2021-04181
    • STUDY00010137
    • P30CA015704
    First Posted:
    May 26, 2021
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Breast Neoplasms
    Prostatic Neoplasms
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Jan 6, 2022