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

September 18, 2017 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

710

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • IT
      • 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, Italy
        • Research Site
  • Spain
    • SP
      • 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, Spain
        • Research Site
  • United States
    • California
      • San Francisco, California, United States
        • Research Site
    • Florida
      • Gainesville, Florida, United States
        • Research Site
      • Sarasota, Florida, United States
        • Research Site
    • Georgia
      • Augusta, Georgia, United States
        • Research Site
    • Massachusetts
      • Worcester, Massachusetts, United States
        • Research Site
    • New York
      • Hackensack, New York, United States
        • Research Site
      • Lake Success, New York, United States
        • Research Site
      • Mineola, New York, United States
        • Research Site
      • The Bronx, New York, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer prior to, or at enrolment in this study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing turnaround time with the new BRCA-testing pathway
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Optum, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2015

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Actual)

September 19, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • D0816R00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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