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Completed

NCT Number: NCT04353973

Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Cancer Patients

This study aims to determine if web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer can provide equal or improved cognitive and affective outcomes when compared to the standard of care delivery model.

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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

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

Cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. With FDA approval for PARP inhibitors in patients with advanced breast, ovarian, pancreatic and prostate cancer, there is an additional therapeutic rationale for testing all breast, ovarian, pancreatic and prostate cancer patients for germline genetic mutations. Yet, access to genetic specialists is limited in many area, and the traditional model of pre- and post-test counseling with a genetic professional will not support the rising indications for cancer genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of testing, while maintaining adequate patient outcomes.

This study aims to assess if traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor can be replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver cancer genetic testing in patients with breast, ovarian, pancreatic and prostate cancer, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.

Specific Aim 1: To determine if web-based eHealth delivery of pre-test and/or post-test counseling can provide equal or improved cognitive and affective short-term and 6-month outcomes as compared to the two-visit standard of care delivery model with a genetic counselor. The investigator's primary outcomes will be changes in knowledge and anxiety. Secondary outcomes will include uptake of testing, depression, cancer specific distress, uncertainty and health behaviors and provider time.

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
  • A personal history of one or more of the following:
  • metastatic breast cancer
  • advanced ovarian cancer (Stage III-IV)
  • metastatic pancreatic cancer
  • metastatic prostate cancer
  • Naive to previous cancer 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 accessable 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 either In-Person or by Remote Services (Telephone or Video Conferencing)

Post-Test Intervention

Other

Secure and accessable 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. Change in Knowledge

    Time frame: Baseline - Within 7 days of Visit 2

    Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better).

  2. Change in Anxiety

    Time frame: Baseline - Within 7 days of Visit 2

    Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in anxiety (better).

Secondary outcomes

  1. Change in Depression

    Time frame: Baseline - Within 7 days of Visit 2

    Patient-Reported Outcomes Measurement Information System (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in depression (better).

  2. Change in Cancer Specific Distress

    Time frame: Baseline - Within 7 days of Visit 2

    Impact of Events Scale (IES) - Score Range = 0-40 Decreased score change indicates a decrease in distress (better).

  3. Change in Uncertainty

    Time frame: Within 7 days of Visit 2 - 6-Month Follow-Up

    Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) - Score Range = 0-85 Decrease in score change indicates a decrease in uncertainty (better).

  4. Change in Health Behaviors

    Time frame: Within 7 days of Visit 2 - 6-Month Follow-Up

    Change in treatment plan and communication of results - Yes/No

  5. Provider Time

    Time frame: Within 7 days of Standard of Care V1

    Time (minutes) provider spends per study participant

  6. Provider Time

    Time frame: Within 7 days of Standard of Care V2

    Time (minutes) provider spends per study participant

  7. Frequency of Uptake of Testing

    Time frame: Within 7 days of Visit 1

    Testing uptake per arm - Yes/No

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • AstraZeneca
  • Basser Center for BRCA
  • Fox Chase Cancer Center
  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients

Acronym: eReach

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 21, 2020
Registry last updated
Jul 29, 2025

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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