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.
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 Type
OBSERVATIONAL
Enrollment
12
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Uptake of disclosure invitation
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.
Time frame: 6 months
Frequency and duration of physical activity
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).
Time frame: 6 months
Frequency and duration of alcohol use
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)
Time frame: 6 months
Current cigarette smoking status
We will measure and compare changes between baseline and 6 months following genetic test disclosure: Current cigarette smoker (Yes/No)
Time frame: 6 months
Quality and amount of sleep
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)
Time frame: 6 months
Frequency of fruit and vegetable consumption
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)
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Time frame: 6 months
Frequency of red meat consumption
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).
Time frame: 6 months
Uptake of genetic testing
The relative proportion of individuals who request and obtain genetic testing on their own by 6 months
Time frame: 6 months
Quality of life
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)
Time frame: 6 months
Perceived cancer risk/worry
Changes in self-reported worry of developing cancer on a scale of 1 (not at all or rarely to 4 (almost all the time)
Time frame: 6 months
Decision regret
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).
Time frame: 6 months