Understanding Genetic Incidental Findings in Your Family (UNIFY Study) (UNIFY)

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

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.

Study Overview

• Status: Completed
• Conditions: Familial Pancreatic Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Familial Pancreatic Cancer Kindred

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: University of California, San Francisco; University of Minnesota
• Investigators: Principal Investigator: Gloria Petersen, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 4, 2019
• Study Completion (Actual): November 4, 2019

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (Estimated): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Family; Cancer; Genetic; Pancreas; History
• Other Study ID Numbers: 15-001209