Understanding Genetic Incidental Findings in Your Family (UNIFY Study)
- Conditions
- Familial Pancreatic Cancer
- Registration Number
- NCT02560896
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Uptake of disclosure invitation 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 Outcome Measures
Name Time Method Frequency and duration of alcohol use 6 months We will measure and compare changes between baseline and 6 months following genetic test disclosure: number of drinks containing alcohol taken per week over previous six months; frequency drinking 6 or more drinks in one occasion in past 6 months (Never; Less than monthly; Monthly; 2 to 3 times per week; 4 or more times per week)
Current cigarette smoking status 6 months We will measure and compare changes between baseline and 6 months following genetic test disclosure: Current cigarette smoker (Yes/No)
Quality and amount of sleep 6 months We will measure and compare changes between baseline and 6 months following genetic test disclosure: Quality of sleep (Very good; Fairly good; Fairly bad; Very bad); Number of hours of sleep in a 24 hour period (hours and minutes)
Uptake of genetic testing 6 months The relative proportion of individuals who request and obtain genetic testing on their own by 6 months
Quality of life 6 months Changes in self-reported quality of life on a scale of 0(a bad as it can be) to 10 (as good as it can be)
Frequency and duration of physical activity 6 months We will measure and compare changes between baseline and 6 months following genetic test disclosure: number of self-reported days per week and exercise duration(minutes).
Frequency of fruit and vegetable consumption 6 months We will measure and compare changes between baseline and 6 months following genetic test disclosure: Number of servings eaten in a typical day (None; 1 or less; 2; 3; 4; 5 or more)
Frequency of red meat consumption 6 months We will measure and compare changes between baseline and 6 months following genetic test disclosure: Number of times consumed per typical week (0; 1 to 5; 6 to 10; 11 to 15; 16 to 20; 21 or more).
Perceived cancer risk/worry 6 months Changes in self-reported worry of developing cancer on a scale of 1 (not at all or rarely to 4 (almost all the time)
Decision regret 6 months Self-reported rating of regret to learn/not learn their relative's genetic research result using a 5-item scale rating (Strongly agree to Strongly disagree).
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States