eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

NCT05427240 | Recruiting

• 2 other identifiers: 13021850242
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized non-inferiority study will use a 2x2 design where traditional standard-of-care pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor are replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver clinical genetic testing in eligible individuals, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• The KnowGene Scale

  Change in Knowledge - Score Range = 0-16, Higher score = Better outcome

  Through study completion, an average of 1 year

• Patient Reported Outcome Measurement Information System (PROMIS)

  Change in General Anxiety - Score Range = 4-20, Lower score = Better outcome

  Through study completion, an average of 1 year

• Uptake of Genetic Services

  Testing uptake per arm - Yes/No

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Patient Reported Outcome Measurement Information System (PROMIS)

  Through study completion, an average of 1 year

• Impact of Events Scale (IES)

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

• Satisfaction with genetic services

  Through study completion, an average of 1 year

• Decisional Regret Scale

  Through study completion, an average of 1 year

Study Arms (4)

ARM A

EXPERIMENTAL

Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor. Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor.

Other: Standard of Care

ARM B

EXPERIMENTAL

Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor. Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.

Other: Pre-Test Intervention; Other: Standard of Care

ARM C

EXPERIMENTAL

Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention. Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor.

Other: Standard of Care; Other: Post-Test Intervention

ARM D

EXPERIMENTAL

Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention. Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.

Other: Pre-Test Intervention; Other: Post-Test Intervention

Interventions

Standard of Care OTHER

Standard of Care with a Genetic Counselor by Remote Services

ARM A; ARM B; ARM C

Post-Test Intervention OTHER

Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

ARM C; ARM D

Pre-Test Intervention OTHER

Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

ARM B; ARM D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Speak and understand English
• Male or Female
• No prior germline genetic testing
• Meet current National Comprehensive Cancer Network (NCCN) guidelines for germline genetic testing

You may not qualify if:

• Communication difficulties such as:
• Uncorrected or uncompensated hearing and/or vision impairment
• Uncorrected or uncompensated speech defects
• Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Fox Chase Cancer Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• Mastaglio E, Egleston B, Lee KT, Fetzer D, Brown S, Domchek SM, Fleisher L, Wen KY, Wagner L, Roberts JS, Cacioppo C, Christiansen J, Howe S, Wood EM, Weinberg M, Karpink K, Selmani E, Feng J, John S, Schweickert K, McLeod B, Bradbury AR. A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eREACH2): study protocol. medRxiv [Preprint]. 2025 Nov 22:2025.11.19.25340515. doi: 10.1101/2025.11.19.25340515.

  PMID: 41332807 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Angela R Bradbury, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela R Bradbury, MD

CONTACT

215 615 3341; Angela.Bradbury@pennmedicine.upenn.edu

Dominique Fetzer, BA

CONTACT

215 662 2753; Dominique.Fetzer@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 22, 2022
• Study Start: September 28, 2022
• Primary Completion: December 24, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)