NCT07471958

Brief Summary

The purpose of the study is to understand patient interest in telehealth and digital tools for pre-test genetic education and/or disclosure of genetic test results. Participants will receive telehealth genetic counseling in the home and may be offered various digital tools to help with the counseling and testing process. These are optional and participants can still speak with a genetic counselor if they wish.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress26%
Sep 2025Mar 2029

Study Start

First participant enrolled

September 2, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

November 13, 2025

Last Update Submit

March 12, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Uptake of Visit 1

    Participant completion of Visit 1 (yes/no)

    Through 6 months

  • Uptake of Digital Visit 1

    Participant completion of digital intervention as an alternative for Visit 1 (yes/no)

    Through 6 months

  • Uptake of genetic testing

    Participant completion of genetic testing and received results/Visit 2 (yes/no)

    Through 6 months

Secondary Outcomes (6)

  • The KnowGene Scale

    Through study completion, an average of 6 months

  • Test result recall

    Through study completion, an average of 6 months

  • Impact of Events Scale (IES)

    Through study completion, an average of 6 months

  • Satisfaction with genetic services

    Through study completion, an average of 6 months

  • Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)

    Through study completion, an average of 6 months

  • +1 more secondary outcomes

Study Arms (1)

Visit 1

All participants will be offered remote telehealth Visit 1 services by telephone or real-time videoconference or by a chatbot (patient choice).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with personal or family history of cancer.

You may qualify if:

  • years of age or older
  • Speak and understand English
  • Meet current National Comprehensive Cancer Network (NCCN) or other national guidelines for germline genetic testing or are interested in genetic counseling based on personal or family history of cancer. Patients with prior genetic testing are eligible if they meet criteria for updated testing, or if post-test genetic counseling services are requested.

You may not qualify if:

  • 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)

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Angela Bradbury, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

March 13, 2026

Study Start

September 2, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations