Understanding Genetic Incidental Findings in Your Family (UNIFY Study)

Familial Pancreatic Cancer Clinical Trial

— UNIFY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560896
• Other study ID #: 15-001209
• Status: Completed
• Start date: August 2015
• Est. completion date: November 4, 2019

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Pancreatic Cancer

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	University of California, San Francisco, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Uptake of genetic testing	The relative proportion of individuals who request and obtain genetic testing on their own by 6 months	6 months
Secondary	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
Secondary	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials