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Enrolling by Invitation

NCT Number: NCT07517666

Genetic Information for Families After Tumor Testing 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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Interactive Chatbot

Other

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.

Primary outcomes

  1. 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)

  2. Uptake of genetic testing

    Time frame: 6 months from consent

    Participant completion of genetic testing (yes/no)

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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)

  6. 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

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Baylor College of Medicine
  • Dana-Farber Cancer Institute
  • Emory University
  • Fox Chase Cancer Center
  • National Cancer Institute (NCI)

Registry information

Official study title

Genetic Information for Families After Tumor Testing (GIFTT) Study

Acronym: GIFTT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

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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