INFORMATION FOR PROMPT PARTICIPANTS
If you have had multiplex testing, your participation in this study can help researchers better understand the role certain genetic variants can have on the genesis of certain cancers.
Please consider enrolling in PROMPT. Below is information that explains this multiplex gene panel registry, including enrollment information, how you can contribute to our ongoing research, your right to privacy, and much more.
HERE IS ALL THE INFORMATION YOU NEED
Click on the tabs below to find out more about PROMPT
Here are some quick links
Brochure
You can download and print the PROMPT Brochure in PDF format by clicking here.
Informational Website
Participants can learn more information about the PROMPT by visiting www.promptstudy.info.
Registration Website
Participants can register and begin participation by visiting Registration Site.
What You Need to Know to Enroll in the PROMPT Study
Who should enroll in PROMPT?
PROMPT is for both men and women, age 18 or older, who have undergone genetic testing for cancer predisposition genes and were found to have a gene variant.
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Eligibility Criteria
We are happy to include anyone who meets our eligibility criteria. Patients and their family members are eligible to participate in PROMPT if they:
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1) Are 18 Years or older
2) Have had multiplex genetic testing,
3) Have been found to carry a variant of unknown/uncertain significance or deleterious mutation, and
4) Are able to understand and navigate an English-language website.
Electronic Consent
Individuals agree to participate in the study through electronic consent. They are not necessarily registered as participants at any of the participating institutions. They will provide consent and research authorization through electronic acknowledgment of the elements of informed consent form provided online through the REDCap instrument. Individuals will read a description of the study and will be consented online using a “statement of research” which will be part of the website. As participants are not registered in person, a waiver of written consent is requested. Completion of the “statement of research” serves in place of the formal written consent and meets the requirements of the Code of Federal Regulations and the Institutional Review Board/Privacy Board.
Participation
Participants agree to be contacted directly by the research team. Participants may be asked to provide copies of their genetic test results and, if available, pathology reports directly related to PROMPT. Alternatively, they may provide a formal HIPAA release of medical records so that PROMPT team can request these documents from their health care providers. Participants may be asked to consider donating samples and referring family members to PROMPT. Such interactions are conducted under a separate IRB-approved protocol by the participating research centers. Family members referred to PROMPT will not be contacted directly by the study team unless they provide consent through the separate protocol.
Privacy and Use of Information
How is Information Shared?
A Research Authorization form must be completed by the Principal Investigator and approved by the IRB and Privacy Board (IRB/PB). The use and disclosure of protected health information from PROMPT will be limited to the individuals and institutions listed on the Research Authorization form.
Data Monitoring
A subset of the PROMPT Steering Committee conducts periodic audits and quality assurance functions and will also oversee the deposition of PROMPT data into appropriate open databases.
IRB Approval
PROMPT was approved by Chesapeake IRB, a central review board. PROMPT submits updates to Chesapeake IRB throughout the year and for annual approval. While no adverse events are anticipated in this low-risk study, all serious adverse effects will be reported to the Chesapeake IRB within two weeks.
Quality Assurance
It is not possible to verify self-reported data entered into the REDCap platform by subjects who choose not to upload test reports or medical records. While this does introduce the possibility of incorrect data entry, any epidemiological study that relies upon subject report is potentially limited by the same considerations, and there is no reason to expect that subjects who choose not to disclose their identity will be any less reliable. For subjects who choose to provide genetic test results and pathology reports, these will be used to verify self-reported items.
What Does Participation Entail?
Survey
Once a participant has agreed to participate in the study, s/he will be asked to fill out a survey. This survey includes questions regarding the participant’s personal health information, family health information, genetic testing result and demographics.
More Survey Details
The survey should take approximately 20 minutes to complete. Information is saved once a participant clicks “continue” to move to the next page. The participant can resume where s/he left off at any time by selecting “Save and Return Later”. Participants will be given a unique link and code to re-enter their survey.
Genetic Test Results
At the end of the survey, the participant is encouraged to upload his/her genetic test result. This allows the PROMPT Team to verify that the patient is in fact eligible for the study. The participant may upload a scanned file (PDF) or take a picture of his/her genetic test results (JPEG).
Follow-Up
The intention of the PROMPT registry is to collect updated health information from participants annually to achieve the primary goal of determining cancer incidence among carriers of different mutations. To this end, participants will be sent, via REDCap, an email reminder annually on the anniversary of their enrollment, requesting that they complete the follow-up questionnaire.