Understanding Genetic Incidental Findings in Your Family (UNIFY Study)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Genomic Incidental Findings Disclosure (GIFD) in a Cancer Biobank: An Ethical, Legal and Social Implications (ELSI) Experiment (Protocol for Aim 3 Intervention)

Conditions
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Familial Pancreatic Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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) | 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) | 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) | 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) | 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). | 6 months | 
| Uptake of genetic testing | The relative proportion of individuals who request and obtain genetic testing on their own by 6 months | 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) | 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) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family, History, Pancreas, Cancer, Genetic