Genetic Information for Families After Tumor Testing Study (GIFTT)

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: Enrolling by invitation
• Conditions: Cancer
• Intervention / Treatment: Other: Interactive Chatbot

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Uptake of digital pre-test chatbot	Participant completion of digital intervention as an alternative for pre-test counseling (yes/no)	6 months from consent
Uptake of genetic testing	Participant completion of genetic testing (yes/no)	6 months from consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Understanding of Genetic Information	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	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	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	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	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	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

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: 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

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID 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