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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03348137
• Other study ID #: 0S-16-16
• Secondary ID: NCI-2017-014500S
• Status: Withdrawn
• Start date: July 1, 2019
• Est. completion date: July 1, 2038

Study information

• Verified date: October 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2038
• Est. primary completion date: July 1, 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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