Genomic Incidental Findings Disclosure (GIFD) in a Cancer Biobank: An Ethical, Legal and Social Implications (ELSI) Experiment (Protocol for Aim 3 Intervention)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Uptake of disclosure invitation
Study Overview
Brief Summary
Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought to proceed when the research participant in a biobank is deceased and there is clinically relevant information that could be disclosed to family members. This study is designed to test a procedure offering genetic information to family members of research participants who participated in a pancreatic cancer biobank in a Health Insurance Portability and Accountability Act (HIPAA) -compliant design.
Detailed Description
To develop, prototype, and evaluate a novel procedure for offering probands' genetic results to family members. The intervention is to offer a deceased research participant's actionable germline genetic research finding, and depending upon the choice made by the next of kin, a disclosure of the research finding by a genetic counselor in a family conference call. Using mixed methods (quantitative and qualitative), the investigators will assess decision making, family communication, and actions and responses in individuals from families in which a proband is known to have a deleterious germline mutation in one of several known cancer susceptibility genes.
Study Design
- Study Type
- Observational
- Observational Model
- Family Based
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Uptake of disclosure invitation
Time Frame: 6 months
The primary outcome is: relative proportions of individuals who, when offered genetic results of a deceased family member who participated in a biobank study, will decide to learn those results. Uptake will be a binary outcome (Yes/No). We will enumerate the number of invited participants who choose to learn results and who choose not to learn results.
Secondary Outcomes
- Frequency and duration of alcohol use(6 months)
- Current cigarette smoking status(6 months)
- Quality and amount of sleep(6 months)
- Uptake of genetic testing(6 months)
- Quality of life(6 months)
- Frequency and duration of physical activity(6 months)
- Frequency of fruit and vegetable consumption(6 months)
- Frequency of red meat consumption(6 months)
- Perceived cancer risk/worry(6 months)
- Decision regret(6 months)