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Candidates for Hereditary Pancreatic Cancer TestingGENERATENCT03762590

GENetic Education Risk Assessment and TEsting Study

A study testing Doxy.me genetic education +/- Color Genomics genetic education and Color Genomics genetic education in people with Candidates for Hereditary Pancreatic Cancer Testing, run by Dana-Farber Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Doxy.me genetic education +/- Color Genomics genetic education and Color Genomics genetic education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteUnited States
Study dates
8 May 2019to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: GENetic Education Risk Assessment and TEsting Study (GENERATE)

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.

Read the 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.

Being tested
Doxy.me genetic education +/- Color Genomics genetic education, Color Genomics genetic education
Keywords
Candidates for Hereditary Pancreatic Cancer Testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxy.me genetic education +/- Color Genomics genetic educationOther

    Doxy.me is a HIPAA compliant telemedicine platform that allows clinicians to provide education to remote patients.

    Genetic education via Doxy.me will consist of a pre-recorded genetic education video and a live interactive video conferencing session with a GENERATE genetic counselor.

    Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.

  • Color Genomics genetic educationOther

    Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.

Study groups in NCT03762590
Study groupRoleWhat they receive
Doxy.me plus Color Genomics Arm (Arm 1)Experimental* Participants in this arm will receive genetic education through an online platform called Doxy.me * The Doxy.me session will consist of two parts: 1) a pre-recorded genetic education video 2) a live interactive video conferencing session with a GENERATE genetic counselor * After completing the Doxy.me session and post intervention questionnaires, participants will be directed to the Color Genomics study portal where they may elect to review Color Genomics' genetic education content or proceed directly to order genetic testing * Intervention is Doxy.me genetic education +/- genetic education via Color Genomics website
Receives: Other: Doxy.me genetic education +/- Color Genomics genetic education
Color Genomics Only Arm (Arm 2)Experimental* Participants in this arm will access genetic education on the Color Genomics website which includes both written information and an educational video * After accessing the Color Genomics website, participants may elect to review educational content or proceed directly to order genetic testing * Intervention is genetic education via Color Genomics website
Receives: Other: Color Genomics genetic education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measure the effect that alternative methods of genetic education and delivery models have on the increase 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 in each arm of the intervention study. We will document how many relatives per family elect to undergo genetic testing and compare the results of this measure between both arms of the study.

    Measured: 2 years

Secondary outcomes (5)
  1. Level of cancer-risk distress

    Measure the degree that individuals worry about getting cancer using the adapted Lerman Breast Cancer Worry Scale. This is an 8 item scale with a total score ranging from 8-32, with high scores indicating more frequent worries. A cut-off of equal to or greater than 14 will indicate moderate to high cancer worry.

    Measured: Baseline, immediately post intervention, 3-4 months post intervention, 15 months post intervention

  2. Increase of knowledge of genetic testing

    Assess the participants' understanding of general concepts learned within a genetic counseling session targeted towards multigene panel testing, including inheritance, inherited cancer risks, possible test results of multi-gene panel testing and limitations, and changes in medical management related to an inherited cancer risk

    Measured: Immediately post intervention

  3. Factors in decision making

    Assess the participants perception of how helpful the genetic education was in deciding to pursue genetic testing using a validated 10 item Preparation for Decision Making Scale. This is a brief validated 10 item measure that assesses the participants perception of how useful a decision support intervention is in preparing the participant to make a health decision. Items are summed and scored, and higher scores indicate higher perceived level of preparation.

    Measured: Immediately post intervention

  4. Degree of family communication about genetic test results

    Measure items pertaining to disclosure of genetic test results to relatives which includes asking if participants communicated at all with specific family members and if they disclosed results of genetic testing to anyone in their family

    Measured: 3-4 months post intervention, 15 months post intervention

  5. Uptake of surveillance for pancreatic, other associated cancers and health behaviors

    Examine appropriate screening (such as mammography, colonoscopy) uptake and health behaviors (i.e. smoking, alcohol use) for those who test positive or negative in both arms of the study

    Measured: Baseline and 15 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2018
  2. Study start8 May 2019
  3. Primary completion12 Dec 2022
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03762590
Sponsor's protocol ID
18-222
Acronym
GENERATE
Status last verified
Jun 2026
First submitted
29 Nov 2018
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • Rodriguez NJ, Furniss CS, Yurgelun MB, Ukaegbu C, Constantinou PE, Fortes I, Caruso A, Schwartz AN, Stopfer JE, Underhill-Blazey M, Kenner B, Nelson SH, Okumura S, Zhou AY, Coffin TB, Uno H, Horiguchi M, Ocean AJ, McAllister F, Lowy AM, Klein AP, Madlensky L, Petersen GM, Garber JE, Lippman SM, Goggins MG, Maitra A, Syngal S. A Randomized Trial of Two Remote Health Care Delivery Models on the Uptake of Genetic Testing and Impact on Patient-Reported Psychological Outcomes in Families With Pancreatic Cancer: The Genetic Education, Risk Assessment, and Testing (GENERATE) Study. Gastroenterology. 2024 May;166(5):872-885.e2. doi: 10.1053/j.gastro.2024.01.042. Epub 2024 Feb 5.

    PubMed 38320723

Questions about this trial

What is this clinical trial studying?

A study testing Doxy.me genetic education +/- Color Genomics genetic education and Color Genomics genetic education in people with Candidates for Hereditary Pancreatic Cancer Testing, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03762590, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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