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NCT Number: NCT05427240

eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Angela Bradbury, MD

CONTACT

About this study

Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Access to genetic specialists is limited in many areas in the US, and the traditional medical delivery model of pre- and post-test counseling with a genetic professional will not support the rising indications for genetic testing. Recent data from the National Health Interview Survey found that <20% of eligible patients with a personal or family history of breast or ovarian cancer underwent genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes.

This study aims to evaluate the effectiveness of offering web-based eHealth delivery alternatives of pre/post-test genetic counseling to provide equal or improved timely uptake of genetic services and testing, and short-term cognitive (e.g. understanding), affective (e.g. distress and uncertainty) and behavioral (risk reducing and screening behaviors and communication to providers and relatives) outcomes in patients with barriers to genetic testing as compared to the traditional two-visit delivery model with a genetic counselor.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 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

Exclusion criteria

-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

Treatment and study plan

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.

Standard of care

Other

Standard of Care with a Genetic Counselor by Remote Services

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.

Primary outcomes

  1. The KnowGene Scale

    Time frame: Through study completion, an average of 1 year

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

  2. Patient Reported Outcome Measurement Information System (PROMIS)

    Time frame: Through study completion, an average of 1 year

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

  3. Uptake of Genetic Services

    Time frame: Through study completion, an average of 1 year

    Testing uptake per arm - Yes/No

Secondary outcomes

  1. Patient Reported Outcome Measurement Information System (PROMIS)

    Time frame: Through study completion, an average of 1 year

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

  2. Impact of Events Scale (IES)

    Time frame: Through study completion, an average of 1 year

    Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome

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

    Time frame: Through study completion, an average of 1 year

    Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome

  4. Satisfaction with genetic services

    Time frame: Through study completion, an average of 1 year

    Differences in satisfaction by Arm - Score Range = 14-70, Higher score = Better outcome

  5. Decisional Regret Scale

    Time frame: Through study completion, an average of 1 year

    Differences in decisional regret by Arm - Score Range = 5-25, Lower score = Better outcome

  6. Provider Time

    Time frame: Through study completion, an average of 1 year

    Time (minutes) provider spends per patient

Study contacts

Contact information is provided by the study sponsor or research team.

Angela R Bradbury, MD

CONTACT

[email protected]

215 615 3341

Dominique Fetzer, BA

CONTACT

[email protected]

215 662 2753

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Fox Chase Cancer Center
  • National Cancer Institute (NCI)

Registry information

Official study title

A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

Acronym: eReach2

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 22, 2022
Registry last updated
Jan 16, 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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