Clinical trial NCT03762590: GENetic Education Risk Assessment and TEsting Study
Official title: GENetic Education Risk Assessment and TEsting Study (GENERATE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Candidates for Hereditary Pancreatic Cancer Testing
Keywords: Candidates for Hereditary Pancreatic Cancer Testing
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: M.D. Anderson Cancer Center
name: Johns Hopkins University
name: University of California, San Diego
name: Weill Medical College of Cornell University
name: Stand Up To Cancer
name: Lustgarten Foundation
First posted: 2018-12-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of the GENERATE Study is to improve genetic testing and cancer prevention in family members of pancreatic cancer patients who may have genetic mutations (inherited changes). The study will measure how different methods of genetic education increase the rate of genetic testing in these families.

This is an investigational study to measure the effects of two methods of genetic education. Participants may elect to undergo genetic testing as part of the study and will be asked to provide a saliva sample via a saliva-testing kit. The genetic testing done in this study is FDA approved and will be processed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.

Up to 1,000 participants will be enrolled in this study.

Detailed description: Around 1 in 10 (10%) pancreatic cancer patients carries an inherited change (mutation) in a gene which can increase the risk of cancer. Relatives of patients with pancreatic cancer are often unaware that the mutation can be passed down through the family. Having information about genetic risk can be important to family members. There may be options for early and/or more frequent screening (to look for cancer or pre-cancer) or early detection recommendations.

This research is being done to study the impact of different methods of teaching about and offering genetic testing to family members of pancreatic cancer patients who may carry a mutation.

Study arms:

Individuals will be randomized (like flipping a coin) by family to one of the two study arms to receive genetic education and elect to undergo genetic testing.

Individuals in Arm 1 (video conference platform plus Color Genomics) will receive genetic education via a pre-recorded educational video and interactive session with the study team through an internet-based platform.

Individuals in Arm 2 (Color Genomics Only) will receive genetic education from Color Genomics, Inc., an online, commercial genetic testing service.

Informed consent:

Participants will be asked to provide informed consent in order to join the study.

Study questionnaires:

Questionnaires will be given at baseline and throughout the duration of the study. Participants will be asked to complete questionnaires through the online study database, called REDCap (paper questionnaires are also an option). The baseline questionnaires will ask participants about their medical history, their experience with pancreatic cancer and other relevant health behaviors.

The follow-up questionnaires will ask about how much participants worried about cancer, how participants made choices, their knowledge gained and how much families shared genetic test results (if participants chose to get testing). The study will also ask about participants' choices to have pancreas exams and other surveillance (long-term screening) procedures, and their lifestyle choices after receiving the intervention.

Genetic testing:

GENERATE offers genetic testing at no cost to participants in the study. Color Genomics will provide the genetic testing services for the study. Participants will be directed to create a personal Color Genomics account that will allow them to enter their personal and family history information, keep track of their genetic testing kit and receive their genetic test results. Participants will be mailed an FDA-approved saliva collection kit from Color Genomics. When participants receive the kit in the mail, they will be able to use the kit's unique barcode number to activate it and link it to their online account. A video on the website will show participants how to provide a large enough saliva sample. It will also contain instructions for how to properly package and mail back the kit to Color Genomics using a pre-paid shipping package.

Getting test results:

It usually takes about 4-6 weeks to get the results back from this genetic test. Participants will receive an email letting them know that their results are available for review through their Color Genomics account or via a phone call with a Color Genomics genetic counselor.

Length of study:

The total participation on this study will last about 18 months, including follow-up. Participants may be contacted regarding participation in future studies.

Eligibility criteria: Inclusion Criteria:

* Individual who is 18 years or older
* Individual who has signed the informed consent
* Individual with:

  --A first-degree relative who has (or had) pancreatic ductal adenocarcinoma (PDAC) OR a second-degree relative who has (or had) PDAC and has a known germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53
* The germline mutation and history of PDAC must be on the maternal side or paternal side of the individual's family
* Individual with a valid United States mailing address
* Individual with access to a healthcare provider and is willing to share genetic test results with that provider/the study team

Exclusion Criteria:

* Individual with a known cancer susceptibility gene
* Individual who has received genetic counseling for cancer risk within the last 3 years
* Individual who has received a bone marrow transplant, who has had a blood transfusion within the last 7 days, or who has an active hematologic malignancy (i.e. leukemia or lymphoma)
* Individual who is unable to sign the informed consent because of mental incompetency or psychiatric illness
* Individual who is unwilling to complete baseline and follow-up questionnaires
* Individual who has a life expectancy of less than 1 year
* Individual with only APC I1307K mutation within their family
* Individual with only PMS2 exons 12-15 deletion mutation within their family

Primary outcomes:
measure: Change of genetic testing among family members of mutation positive PDAC patients, among family members of mutation positive individuals with a family history of PDAC and among first-degree relatives of PDAC patients
timeFrame: 2 years
Secondary outcomes:
measure: Level of cancer-risk distress
timeFrame: Baseline, immediately post intervention, 3-4 months post intervention, 15 months post intervention
measure: Increase of knowledge of genetic testing
timeFrame: Immediately post intervention
measure: Factors in decision making
timeFrame: Immediately post intervention
measure: Degree of family communication about genetic test results
timeFrame: 3-4 months post intervention, 15 months post intervention
measure: Uptake of surveillance for pancreatic, other associated cancers and health behaviors
timeFrame: Baseline and 15 months post intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Sapna Syngal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: