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CancereReachNCT04353973

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

A study testing Pre-Test Intervention and Post-Test Intervention in people with Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
Pre-Test Intervention and Post-Test Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteUnited States
Study dates
17 Aug 2020to 13 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • metastatic pancreatic cancer
  • metastatic prostate cancer
  • Naive to previous cancer germline genetic testing

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center at University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official 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

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.

Read the detailed description

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.

Conditions
Cancer
Being tested
Pre-Test Intervention, Standard of Care, Post-Test Intervention
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-Test InterventionOther

    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 CareOther

    Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)

  • Post-Test InterventionOther

    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.

Study groups in NCT04353973
Study groupRoleWhat they receive
ARM AExperimentalVisit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing). Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).
Receives: Other: Standard of Care
ARM BExperimentalVisit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing). Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.
Receives: Other: Standard of Care; Other: Post-Test Intervention
ARM CExperimentalVisit 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 either in-person or by remote services (Telephone or Video Conferencing).
Receives: Other: Pre-Test Intervention; Other: Standard of Care
ARM DExperimentalVisit 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.
Receives: Other: Pre-Test Intervention; Other: Post-Test Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Knowledge

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

    Measured: Baseline - Within 7 days of Visit 2

  2. Change in Anxiety

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

    Measured: Baseline - Within 7 days of Visit 2

Secondary outcomes (7)

  1. Change in Depression

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

    Measured: Baseline - Within 7 days of Visit 2

  2. Change in Cancer Specific Distress

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

    Measured: Baseline - Within 7 days of Visit 2

  3. Change in Uncertainty

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

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

  4. Change in Health Behaviors

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

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

  5. Provider Time

    Time (minutes) provider spends per study participant

    Measured: Within 7 days of Standard of Care V1

  6. Provider Time

    Time (minutes) provider spends per study participant

    Measured: Within 7 days of Standard of Care V2

  7. Frequency of Uptake of Testing

    Testing uptake per arm - Yes/No

    Measured: Within 7 days of Visit 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start17 Aug 2020
  3. Primary completion15 Aug 2024
  4. Study completion13 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353973
Sponsor's protocol ID
UPCC 11919
Other IDs
IRB#833370
Acronym
eReach
Status last verified
Apr 2025
First submitted
3 Apr 2020
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee KT, McLeod B, Egleston B, Brown S, Howe S, Fetzer D, Gutstein L, Cacioppo C, Clark D, Domchek SM, Ebrahimzadeh J, Falcone D, Ofidis D, Griffin H, Mim R, Hernandez S, Fleisher L, Karpink K, Selmani E, Tahsin A, Wagner L, Weinberg M, Yi-Wen K, Wood E, Bradbury AR. An eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Patients With Metastatic Cancers: Protocol for a Randomized Trial. JMIR Res Protoc. 2025 Aug 25;14:e72515. doi: 10.2196/72515.

    PubMed 40853717

Questions about this trial

What is this clinical trial studying?

A study testing Pre-Test Intervention and Post-Test Intervention in people with Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Knowledge (time frame: Baseline - Within 7 days of Visit 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353973, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.

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