Clinical trial NCT02560896: Understanding Genetic Incidental Findings in Your Family (UNIFY Study)
Official title: Genomic Incidental Findings Disclosure (GIFD) in a Cancer Biobank: An Ethical, Legal and Social Implications (ELSI) Experiment (Protocol for Aim 3 Intervention)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Pancreatic Cancer
Keywords: Family
History
Pancreas
Cancer
Genetic
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: University of California, San Francisco
First posted: 2015-09-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Familial Pancreatic Cancer Kindred

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.

Eligibility 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

Primary outcomes:
measure: Uptake of disclosure invitation
timeFrame: 6 months
Secondary outcomes:
measure: Frequency and duration of physical activity
timeFrame: 6 months
measure: Frequency and duration of alcohol use
timeFrame: 6 months
measure: Current cigarette smoking status
timeFrame: 6 months
measure: Quality and amount of sleep
timeFrame: 6 months
measure: Frequency of fruit and vegetable consumption
timeFrame: 6 months
measure: Frequency of red meat consumption
timeFrame: 6 months
measure: Uptake of genetic testing
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Perceived cancer risk/worry
timeFrame: 6 months
measure: Decision regret
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gloria Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: