Oncology Research Information Exchange Network in Improving Genetic Screening Rate in Patients With Cancer

ORIEN-PROGENY Family History Questionnaire Study: Recognizing Inherited Susceptibility to Cancer

This research trial studies how well Oncology Research Information Exchange Network (ORIEN) works in improving genetic screening rate in patients with cancer. Implementation of Progeny Genetic Pedigree and Family History Questionnaire software across all ORIEN member institutions may add value and utility for recognizing and caring for patients with an inherited susceptibility to cancer.

Study Overview

• Status: Withdrawn
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

I. Measure the change in uptake of cancer genetic referrals and genetic testing in the ORIEN system of cancer centers implementing the Progeny Family History Questionnaire (FHQ).

SECONDARY OBJECTIVES:

I. Follow and estimate utilization of preventive health behaviors among Progeny FHQ users across all institutions.

II. Compare utilization of preventive health behavior between Progeny FHQ risk identification and genetic testing.

OUTLINE:

Patients take Progeny Genetic Pedigree and Family History Questionnaire. Results are reviewed by the site specific research coordinator and/or genetic counselor to assess whether a patient fulfills criteria for referral to the site specific cancer genetics clinic for further evaluation.

After completion of study, patients are followed up at 6 months after disclosure of genetic testing results.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients consented to the Total Cancer Care Protocol protocol

Description

Inclusion Criteria:

• Limited to those patients who are consented to the Total Cancer Care Protocol (TCCP) protocol
• Able to understand and sign the TCCP informed consent, California subject?s bill of rights, Health Insurance Portability and Accountability Act (HIPAA), and research authorization form directly or through an authorized representative; the informed consent, subject?s bill of rights, HIPAA, and research authorization will be available in both English and Spanish languages

Exclusion Criteria:

• Individuals who are not registered as patients for outpatient or inpatient care to the TCCP protocol
• Individuals who are unable to understand or sign the TCCP informed consent, subject?s bill of rights, HIPAA, and research authorization in either English or Spanish

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-Correlative (questionnaire); Patients take Progeny Genetic Pedigree and Family History Questionnaire. Results are reviewed by the site specific research coordinator and/or genetic counselor to assess whether a patient fulfills criteria for referral to the site specific cancer genetics clinic for further evaluation.	Other: Questionnaire Administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Rates of Genetic Testing	Will compare rates of genetic testing before and after implementation of Progeny Family History Questionnaire (FHQ) using the stratified Chi-square test.	Up to 30 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gregory Idos, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): July 1, 2037
• Study Completion (Anticipated): July 1, 2038

Study Registration Dates

• First Submitted: November 4, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 0S-16-16 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2017-01450 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No