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eHealth Cancer Genetic Counseling for Cancer (eReach Trial)

N/A

Recruiting

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

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

Must not have

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 baseline - within 7 days of visit 2

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare web-based eHealth cancer counseling to the standard of care to see if it is equally or more effective.

Who is the study for?

This trial is for adults who speak English and have certain advanced cancers (metastatic breast, ovarian stages III-IV, pancreatic, or prostate cancer) and haven't had genetic testing for cancer before. It's not suitable for those with hearing/vision/speech issues or uncontrolled mental conditions that affect understanding of the study.

What is being tested?

The study tests if web-based eHealth delivery of genetic counseling before and after testing can match or surpass standard in-person care in terms of patients' knowledge and emotional well-being.

What are the potential side effects?

Since this trial involves educational interventions rather than medications, traditional side effects are not expected. However, participants may experience a range of emotions as they learn about their genetic risks.

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 had advanced cancer (breast, ovarian, pancreatic, prostate) and haven't had genetic testing for it.

Exclusion Criteria

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

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I do not have any mental or severe physical conditions that prevent me from understanding this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - within 7 days of visit 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline - within 7 days of visit 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - within 7 days of visit 2 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Anxiety

Change in Knowledge

Secondary study objectives

Change in Cancer Specific Distress

Change in Depression

Change in Health Behaviors

+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 either in-person or by remote services (Telephone or Video Conferencing).

Group III: ARM BExperimental Treatment2 Interventions

Visit 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.

Group IV: ARM AExperimental Treatment1 Intervention

Visit 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).

0 / 3Eligibility criteria met