Familial Pancreatic Cancer
Conditions
Keywords
Family, History, Pancreas, Cancer, Genetic
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.
Interventions
None listed
Sponsors
University of Minnesota
University of California, San Francisco
Mayo Clinic
Study design
Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Family members and others authorized to receive health information of participants enrolled under Institutional Review Board (IRB) #354-06 and #355-06 who carry one of several known cancer susceptibility genes. * Mentally competent and able to provide informed consent * Able to understand and read English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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). |
| 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) |
| 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). |
| 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). |
Countries
United States
Outcome results
None listed