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eHealth Genetic Testing for Cancer (eReach2 Trial)

N/A

Recruiting

Led By Angela R Bradbury, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

No prior germline genetic testing

Must not have

Communication difficulties such as uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of standard genetic counseling to a self-directed web-based intervention.

Who is the study for?

This trial is for adults who speak English and meet the guidelines for genetic testing due to cancer risk, but haven't had germline genetic testing before. It's not suitable for those with uncontrolled mental conditions or severe physical impairments that affect communication or understanding of the study.

What is being tested?

The study tests if web-based eHealth interventions can replace traditional in-person counseling by a genetic counselor without compromising care quality. Participants are randomly assigned to either standard care or self-directed online sessions before and after genetic testing.

What are the potential side effects?

Since this trial involves non-medical interventions like web-based education and counseling, typical medical side effects are not expected. However, participants may experience emotional or psychological responses to information about their cancer risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have not had genetic testing for inherited conditions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe mental, physical, or cognitive issues that prevent me from understanding this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The KnowGene Scale

Uptake of Genetic Services

Secondary study objectives

Decisional Regret Scale

Impact of Events Scale (IES)

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: ARM DExperimental Treatment2 Interventions

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.

Group II: ARM CExperimental Treatment2 Interventions

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.

Group III: ARM BExperimental Treatment2 Interventions

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.

Group IV: ARM AExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met