Clinical trial NCT02406235: Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer
Official title: Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer - ENGAGE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Optum, Inc.
First posted: 2015-04-02
Enrollment: 710
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer prior to, or at enrolment in this study

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing turnaround time with the new BRCA-testing pathway
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Research Site
state: California
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Hackensack
country: United States
facility: Research Site
state: New York
city: Lake Success
country: United States
facility: Research Site
state: New York
city: Mineola
country: United States
facility: Research Site
state: New York
city: The Bronx
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Brescia
country: Italy
facility: Research Site
state: IT
city: Genova
country: Italy
facility: Research Site
state: IT
city: Milano
country: Italy
facility: Research Site
state: IT
city: Modena
country: Italy
facility: Research Site
state: IT
city: Napoli
country: Italy
facility: Research Site
state: IT
city: Roma
country: Italy
facility: Research Site
state: IT
city: Torino
country: Italy
facility: Research Site
state: IT
city: A Coruna
country: Spain
facility: Research Site
state: SP
city: Barcelona
country: Spain
facility: Research Site
state: SP
city: Caceres
country: Spain
facility: Research Site
state: SP
city: Cordoba
country: Spain
facility: Research Site
state: SP
city: Madrid
country: Spain
facility: Research Site
state: SP
city: Murcia
country: Spain
facility: Research Site
state: SP
city: Palma de Mallorca
country: Spain
facility: Research Site
state: SP
city: Zaragoza
country: Spain
facility: Research Site
state: SP
Study officials:
References:
citation: Colombo N, Huang G, Scambia G, Chalas E, Pignata S, Fiorica J, Van Le L, Ghamande S, Gonzalez-Santiago S, Bover I, Grana Suarez B, Green A, Huot-Marchand P, Bourhis Y, Karve S, Blakeley C. Evaluation of a Streamlined Oncologist-Led BRCA Mutation Testing and Counseling Model for Patients With Ovarian Cancer. J Clin Oncol. 2018 May 1;36(13):1300-1307. doi: 10.1200/JCO.2017.76.2781. Epub 2018 Mar 20.