CancereReach2NCT05427240
eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
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.
Trial 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… 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
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No prior germline genetic testing
- Meet current National Comprehensive Cancer Network (NCCN) guidelines for 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 the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Hybrid Type I Effectiveness-Implementation Study of an 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.
Read the detailed description
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.
- 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 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 CareOther
Standard of Care with a Genetic Counselor by Remote Services
Post-Test InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. 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.
The KnowGene Scale
Change in Knowledge - Score Range = 0-16, Higher score = Better outcome
Measured: 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
Measured: Through study completion, an average of 1 year
Uptake of Genetic Services
Testing uptake per arm - Yes/No
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Patient Reported Outcome Measurement Information System (PROMIS)
Change in General Depression - Score Range = 4-20, Lower score = Better outcome
Measured: Through study completion, an average of 1 year
Impact of Events Scale (IES)
Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome
Measured: Through study completion, an average of 1 year
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome
Measured: Through study completion, an average of 1 year
Satisfaction with genetic services
Differences in satisfaction by Arm - Score Range = 14-70, Higher score = Better outcome
Measured: Through study completion, an average of 1 year
Decisional Regret Scale
Differences in decisional regret by Arm - Score Range = 5-25, Lower score = Better outcome
Measured: Through study completion, an average of 1 year
Provider Time
Time (minutes) provider spends per patient
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start28 Sep 2022
- Primary completion24 Dec 2025
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fox Chase Cancer Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Angela R Bradbury, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427240
- Sponsor's protocol ID
- 13021
- Other IDs
- 850242
- Acronym
- eReach2
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mastaglio E, Egleston B, Lee KT, Fetzer D, Brown S, Domchek SM, Fleisher L, Yi-Wen K, Wagner L, Roberts S, 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. BMC Cancer. 2026 Jul 31;26(1):1307. doi: 10.1186/s12885-026-16620-z.
PubMed 42934585Mastaglio 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.
PubMed 41332807
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
- ClinicalTrials.gov ID
- NCT05427240
- Acronym / sponsor ID
- eReach2 / 13021
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Fox Chase Cancer Center, National Cancer Institute (NCI)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Other: Standard of CareVisit 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. |
| ARM B | Experimental | Other: Pre-Test Intervention, Other: Standard of CareVisit 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. |
| ARM C | Experimental | Other: Standard of Care, Other: Post-Test InterventionVisit 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. |
| ARM D | Experimental | Other: Pre-Test Intervention, Other: Post-Test InterventionVisit 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Test InterventionSecure 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. | Other | ARM B, ARM D |
| Standard of CareStandard of Care with a Genetic Counselor by Remote Services | Other | ARM A, ARM B, ARM C |
| Post-Test InterventionSecure 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. | Other | ARM C, ARM D |
Primary outcome
The KnowGene Scale
Time frame: Through study completion, an average of 1 year
Change in Knowledge - Score Range = 0-16, Higher score = Better outcome
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
Uptake of Genetic Services
Time frame: Through study completion, an average of 1 year
Testing uptake per arm - Yes/No
6 secondary outcomes
Patient Reported Outcome Measurement Information System (PROMIS)
Time frame: Through study completion, an average of 1 year
Impact of Events Scale (IES)
Time frame: Through study completion, an average of 1 year
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
Time frame: Through study completion, an average of 1 year
Satisfaction with genetic services
Time frame: Through study completion, an average of 1 year
Decisional Regret Scale
Time frame: Through study completion, an average of 1 year
Provider Time
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 42934585Mastaglio E, Egleston B, Lee KT, Fetzer D, Brown S, Domchek SM, Fleisher L, Yi-Wen K, Wagner L, Roberts S, 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. BMC Cancer. 2026 Jul 31;26(1):1307. doi: 10.1186/s12885-026-16620-z.
- Derived from this study: PubMed 41332807Mastaglio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela R Bradbury, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The KnowGene Scale (time frame: Through study completion, an average of 1 year). The study lists 3 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 NCT05427240, which also lists 2 linked publications.
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 20 Oct 2026.