NCT07517666

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Apr 2026Mar 2028

Study Start

First participant enrolled

April 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Understanding of Genetic Information

    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

    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

    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

    Within 7 days post-education, and within 7 days after disclosure of genetic test results

  • Psychosocial impact of returning genomic findings

    Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results

  • +1 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL

Genetic counseling via digital tools and telemedicine

Other: Interactive Chatbot

Interventions

Interactive ChatbotOTHER

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.

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 8, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)