Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer

Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer Clinical Trial

— ENGAGE  

Official title:

Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer - ENGAGE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406235
• Other study ID #: D0816R00006
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: September 18, 2017
• Start date: April 21, 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: September 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall objective of this study is to assess turnaround time, pre-BRCA test onco-genetic counselling quality and satisfaction with a new onco-genetic BRCA testing model.

Description:

This will be a prospective observational study of patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer prior to, or at enrolment in this study. The study is descriptive in nature and does not attempt to test any specific a priori hypotheses.

Clinical teams (physicians and nurses) will be trained to discuss BRCA testing with ovarian cancer patients who meet study criteria and consent to participate in the study. Patients will be recruited from participating sites in North America and Europe. Patients selected per the study inclusion and exclusion criteria will be consented for participation in the study. Patients will be recruited during an estimated 12 month period and participating patients will be followed from enrollment in the study until provision of BRCA test results, final genetics counselling, and completion of satisfaction survey or death. A case report form will be developed to collect information on the primary variable of interest (i.e., turnaround time), patient and disease characteristics, medical history, treatment patterns and outcome of the BRCA test. In addition, a survey will be developed to evaluate patient's assessment of pre- BRCA onco-genetic counseling quality and satisfaction with onco-genetic testing process.

Finally, surveys will be developed to evaluate oncologist (or oncology nurse) and genetic counselor's assessment of the processes associated with the onco-genetic testing pathway.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 710
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer

• Patients aged 18 years or older at ovarian cancer diagnosis

• Provision of written informed consent

• Patient is able to read, write, and understand the material presented to them as part of this study, per the discretion of the physician

Exclusion Criteria:

• Patients with low grade epithelial ovarian cancer or non-epithelial ovarian cancer

• Patients enrolled in an interventional clinical trial for ovarian cancer or other malignancy at the time of conduct of this study

• Patients with BRCA testing any time prior to the study enrollment

Related Conditions & MeSH terms

• Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Italy	Research Site	Brescia	IT
Italy	Research Site	Genova	IT
Italy	Research Site	Milano	IT
Italy	Research Site	Modena	IT
Italy	Research Site	Napoli	IT
Italy	Research Site	Roma	IT
Italy	Research Site	Torino	IT
Spain	Research Site	A Coruna	SP
Spain	Research Site	Barcelona	SP
Spain	Research Site	Caceres	SP
Spain	Research Site	Cordoba	SP
Spain	Research Site	Madrid	SP
Spain	Research Site	Murcia	SP
Spain	Research Site	Palma de Mallorca	SP
Spain	Research Site	Zaragoza	SP
United States	Research Site	Augusta	Georgia
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Gainesville	Florida
United States	Research Site	Hackensack	New York
United States	Research Site	Lake Success	New York
United States	Research Site	Mineola	New York
United States	Research Site	Providence	Rhode Island
United States	Research Site	San Francisco	California
United States	Research Site	Sarasota	Florida
United States	Research Site	The Bronx	New York
United States	Research Site	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Optum

Countries where clinical trial is conducted

United States,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing turnaround time with the new BRCA-testing pathway	The primary objectives include a) assessing turnaround time with the new BRCA (Breast Cancer)-testing pathway; b) patient's assessment of pre-BRCA test onco-genetic counselling quality and satisfaction with the onco-genetic BRCA testing pathway; c) oncologists, and genetic counsellor's assessment of onco-genetic BRCA testing process. The study will be limited to patients with a diagnosis of ovarian cancer.	participating patients will be followed from enrollment in the study until provision of BRCA test results, final genetics counselling and completion of satisfaction survey or death, an expected average of 2 months

External Links

•   D0816R00006_CSR_Synopsis.pdf