Lynch Syndrome affects about 1 in 300 people, and greatly increases one’s risk for a variety of cancers, including colon, rectal, uterine, ovarian, urinary tract, and other malignancies. It is the leading cause of hereditary colorectal (colon) cancer, and a common cause of endometrial cancer. The Dana-Farber Cancer Institute (DFCI) aimed to establish a comprehensive system and cancer registry to learn about new and ongoing options for individuals affected by Lynch syndrome.
To achieve this aim, DFCI chose to partner with Vibrent Health and the University of Pennsylvania. The primary goal of this study is to help researchers develop strategies that can improve prevention, early detection, and treatment of cancer by collecting clinical information and various biological samples from individuals with Lynch syndrome.
The eligibility criteria includes participants who are aged 18 or older, and who have one of the following:
1 in 300
People are estimated to be affected by Lynch syndrome
Types of wearable data collected from Apple Health
Surveys questions for phenotypic data collection
The Lynch syndrome study team collaborated with Vibrent Health to provide a study infrastructure that would accelerate eConsent and data collection for participants in the cancer registry. As part of this collaboration, Vibrent implemented a highly secure and privacy-preserving participant portal and eConsent experience built on Vibrent’s Participant Experience Manager product.
The study uses the following methods of data collection:
All participants can create an account for themselves on the participant portal for the Lynch Syndrome registry. This portal, available as a web or mobile application, provides participants with access to surveys, other data collection methods, their user account details, and more information about the study.
Vibrent provides a secure, privacy-protecting eConsent platform for the Lynch Syndrome study through its website features. Participants watch an educational study video to better understand what they must do as part of the study, then complete the steps of consent.
Participant-Generated Health Surveys
The study obtains information from participants through surveys. Surveys can be sent via email or SMS to participants on initial registration and subsequent annual follow-ups. Surveys can also be delivered through postal mail, completed on paper, then entered by research staff into the Vibrent research database. The data collection in these surveys includes:
Electronic Health Record Data (EHR)
The Lynch Syndrome registry also collects participant electronic health record data (EHR). For participants who do not receive care from the Dana-Farber Cancer Institute, the study team will request medical records after obtaining signed release of information.
Vibrent helps DFCI to perform data collection, upon participant consent, automatically from EHR systems, including Epic and Cerner. Data collected from the EHR include:
Patient-Generated Data from Wearables (Apple Health)
In addition to EHR, participants using Apple Health can connect and share data from their wearable device with the study team, from within the cancer registry participant portal.
Biospecimen Sample Collection
Biological specimens are obtained from consented participants, in order for the study team to incorporate genomic data into the research study dataset. Specimens are collected as part of participant’s routine clinical care.
Options for biospecimen collection include time of consent, pre-paid mailed kit, external lab, or separate appointment at DFCI. Specimens collected include:
Because of the specific focus of the cancer registry, the cohort only includes participants with known or suspected Lynch syndrome. To identify these potential participants, the Lynch Syndrome study team uses Vibrent Research Cloud to perform outreach using digital methods like email and SMS.
The team also distributes its IRB-approved study materials through study coordinators, DFCI physicians and staff, during in-person interactions, social media, brochures, flyer, and mail.
Using Vibrent Health’s Participant Experience Manager, recruitment for interested individuals can be automated through the participant-facing tools, and study eConsent forms.
Email and SMS engagement
The study team uses Research Cloud to send participants periodic engagement communications via email, mobile phone push notifications or SMS messaging. The participant can choose the method of messaging they prefer through the Participant Portal, which runs on Participant Experience Manager.
The study team sends messages that include:
Return of Results
As a benefit of participation in the research study, participants can choose whether or not to receive information from the study. During the consent process, participants can clarify what, if any, individual results they wish to receive should any become available that are deemed appropriate for return.
The Dana-Farber Cancer Institute, by creating an efficient and secure collection and storage of clinical data and specimens by those that are affected by Lynch Syndrome over the course of time will result in improvement of care, and potential prevention.
Registration in the cancer registry will be ongoing, and any clinical significance of results is unknown. In order to expand participation, partnering with Vibrent Health provides DFCI an infrastructure that accelerates eConsent, data collection, while providing security and privacy.