Clinical Trial: Understanding Genetic Incidental Findings in Your Family (UNIFY Study)

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational [Patient Registry]

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

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 Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: Uptake of disclosure invitation [ Time Frame: 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.


Original Primary Outcome: Choice/uptake of learning genetic research result [ Time Frame: 6 months ]

We will objectively enumerate the number of invited participants who choose to learn results and who choose not to learn results


Current Secondary Outcome:

  • Frequency and duration of physical activity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    The relative proportion of individuals who request and obtain genetic testing on their own by 6 months
  • Quality of life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).


Original Secondary Outcome:

  • Behavioral impact [ Time Frame: 6 months ]
    We will measure and compare baseline and 4-6 months following gene test result participant self assessment of physical activity, alcohol use, smoking, sleep, and fruit/vegetable/red meat consumption
  • Health care utilization [ Time Frame: 6 months ]
    We will measure and compare baseline and 4-6 months following gene test result genetic testing uptake, insurance purchasing, healthcare utilization and access to care, and cancer screening and surveillance.
  • Quality of life [ Time Frame: 6 months ]
    We will measure and compare baseline and 4-6 months following gene test result participant self-assessment of self-esteem, anxiety, depression, global self-related health, emotional health, and overall quality of life.
  • Perceived cancer risk/worry [ Time Frame: 6 months ]
    We will measure and compare baseline and 4-6 months following gene test result participant self assessment of cancer worry, perceived risk of cancer, and perceived stigma


Information By: Mayo Clinic

Dates:
Date Received: August 27, 2015
Date Started: August 2015
Date Completion: November 2017
Last Updated: February 15, 2017
Last Verified: February 2017