Understanding Genetic Incidental Findings in Your Family (UNIFY Study)

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02560896

Collaborator

University of Minnesota (Other), University of California, San Francisco (Other)

Enrollment

Location

51.1

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

12 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

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 Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Nov 4, 2019

Actual Study Completion Date :

Nov 4, 2019

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).
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 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).
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.