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.
Brief Title
Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT02406235
Org Class
Industry
Org Full Name
AstraZeneca
Org Study Id
D0816R00006
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer - ENGAGE Study
Primary Outcomes
Outcome Description
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.
Outcome Measure
Assessing turnaround time with the new BRCA-testing pathway
Outcome Time Frame
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
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer prior to, or at enrolment in this study
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Gloria Huang
Investigator Email
ghuang@montefiore.org
Investigator Phone
718-405-8082