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Completed

NCT Number: NCT02560896

Understanding Genetic Incidental Findings in Your Family (UNIFY Study)

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.

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Key information

Conditions

Familial Pancreatic Cancer Neoplasms Pancreatic carcinoma, familial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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).

  7. 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

  8. 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)

  9. 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)

  10. 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • University of California, San Francisco
  • University of Minnesota

Registry information

Official study title

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

Acronym: UNIFY

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2015
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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