- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471958
Implementation of eHealth Delivery Alternatives for Cancer Genetic Testing for Hereditary Cancer (eREACH3) (eREACH3)
Study Overview
Status
Conditions
Detailed Description
The goal of the eREACH3 Study is to evaluate the implementation of these tools into remote genetic services, evaluating uptake and use of digital tools and outcomes in representative clinical populations. The initial protocol will include two genetic counseling visits, providing comparison outcomes. Future amendments will be provided as digital tools are ready for implementation.
Specific Aim 1: (Reach) Evaluate the uptake, use and acceptability of digital delivery alternatives in remote genetic services provided as alternatives to the traditional two-visit model with a genetic counselor.
Specific Aim 2: (Effectiveness) Evaluate short-term and 6 month patient reported cognitive, affective and behavioral outcomes (2a) with remote genetic services and digital alternatives in representative clinical populations and moderators of outcomes (2b).
Specific Aim 3: (Implementation) Evaluate provider time associated with implementation of remote telehealth services and digital delivery alternatives and barriers and facilitators to future clinical implementation.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kelsey Karpink
- Phone Number: 215-662-3531
- Email: kelsey.karpink@pennmedicine.upenn.edu
Study Contact Backup
- Name: Angela Bradbury, MD
- Phone Number: 215-615-3341
- Email: angela.bradbury@pennmedicine.upenn.edu
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Abramson Cancer Center at the University of Pennsylvania
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Contact:
- Angela Bradbury, MD
- Phone Number: 215-615-3341
- Email: angela.bradbury@pennmedicine.upenn.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- Speak and understand English
- Meet current National Comprehensive Cancer Network (NCCN) or other national guidelines for germline genetic testing or are interested in genetic counseling based on personal or family history of cancer. Patients with prior genetic testing are eligible if they meet criteria for updated testing, or if post-test genetic counseling services are requested.
Exclusion Criteria:
- Communication difficulties such as:
- Uncorrected or uncompensated hearing and/or vision impairment. Patients who can successfully use clinical assistance devices are not excluded.
- Uncorrected or uncompensated speech defects. Patients who can successfully use clinical assistance devices are not excluded.
- Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Visit 1
All participants will be offered remote telehealth Visit 1 services by telephone or real-time videoconference or by a chatbot (patient choice).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Uptake of Visit 1
Time Frame: Through 6 months
|
Participant completion of Visit 1 (yes/no)
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Through 6 months
|
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Uptake of Digital Visit 1
Time Frame: Through 6 months
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Participant completion of digital intervention as an alternative for Visit 1 (yes/no)
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Through 6 months
|
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Uptake of genetic testing
Time Frame: Through 6 months
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Participant completion of genetic testing and received results/Visit 2 (yes/no)
|
Through 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The KnowGene Scale
Time Frame: Through study completion, an average of 6 months
|
Change in Knowledge - Score Range = 0-16, Higher score = Better outcome
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Through study completion, an average of 6 months
|
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Test result recall
Time Frame: Through study completion, an average of 6 months
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Recall of genetic testing results
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Through study completion, an average of 6 months
|
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Impact of Events Scale (IES)
Time Frame: Through study completion, an average of 6 months
|
Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome
|
Through study completion, an average of 6 months
|
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Satisfaction with genetic services
Time Frame: Through study completion, an average of 6 months
|
Differences in satisfaction - Score Range = 14-70, Higher score = Better outcome
|
Through study completion, an average of 6 months
|
|
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
Time Frame: Through study completion, an average of 6 months
|
Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome
|
Through study completion, an average of 6 months
|
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Decisional Regret Scale
Time Frame: Through study completion, an average of 6 months
|
Differences in decisional regret - Score Range = 5-25, Lower score = Better outcome
|
Through study completion, an average of 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Angela Bradbury, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 12025
- IRB#858825 (Other Identifier: University of Pennsylvania IRB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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