Genetic Information for Families After Tumor Testing Study (GIFTT)

July 28, 2026 updated by: Abramson Cancer Center at Penn Medicine

Genetic Information for Families After Tumor Testing (GIFTT) Study

The purpose of this study is to develop and implement a methodology of digital tools paired with telemedicine to improve cascade testing for clinically significant germline mutations among family members of children with cancer who have a pathogenic or likely pathogenic(P/LP) germline variant in a cancer predisposition gene.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Biological parent of a child enrolled in the ORIGen cohort (AEPI24N1) who has a confirmed P/LP germline variant in a CPG.
  • 18 years of age or older.
  • Speak and understand English.

Exclusion Criteria:

  • Previous genetic testing for the familial variant.

  • Communication difficulties such as:

    • Uncorrected or uncompensated hearing and/or vision impairment. Patients who can successfully use clinical assistance devices are not excluded.
    • Uncorrected or uncompensated speech defects. Patients who can successfully use clinical assistance devices are not excluded.
    • Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Arm
Genetic counseling via digital tools and telemedicine
Other: Interactive Chatbot
The chatbot intervention will provide biological parents the option to complete pre-test education using an interactive chatbot as an alternative to remote counseling with a genetic counselor. This interactive chatbot will provide opportunities for longitudinal educational and information support, reminders for scheduling next steps, and the option to send specific questions to the genetic counseling team.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Uptake of digital pre-test chatbot
Time Frame: 6 months from consent
Participant completion of digital intervention as an alternative for pre-test counseling (yes/no)
6 months from consent
Uptake of genetic testing
Time Frame: 6 months from consent
Participant completion of genetic testing (yes/no)
6 months from consent

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Understanding of Genetic Information
Time Frame: Change from Baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results
Will be evaluated using an adapted version of the KnowGene Scale, a 16-item scale administered to patients after genetic testing and/or genetic counseling to measure their understanding of the health implications of genetic testing results
Change from Baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results
General anxiety and Depression
Time Frame: Change from baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results
Will be measured by the 4-item each short Patient Reported Outcomes Measurement Information System (PROMIS) measures
Change from baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results
Reactions to genetic information
Time Frame: Change from baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results
Will be measured using an 8-item Impact of Events Scale (IES)
Change from baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results
Satisfaction with genetic services
Time Frame: Within 7 days post-education, and within 7 days after disclosure of genetic test results
Will be assessed with a 14-items evaluating satisfaction with genetic services
Within 7 days post-education, and within 7 days after disclosure of genetic test results
Psychosocial impact of returning genomic findings
Time Frame: Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results
Evaluation of distress, uncertainty and positive responses to receipt of genetic test results using 17 items from the MICRA (Multi-dimensional Impact of Cancer Risk Assessment Questionnaire)
Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results
Decisional regret
Time Frame: Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results
Evaluated using 5-item validated Decision Regret Scale
Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center at Penn Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Fox Chase Cancer Center
Baylor College of Medicine
Dana-Farber Cancer Institute
Emory University
Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 05026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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