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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#858825 | Other Identifier | University of Pennsylvania IRB |
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| Name | Class |
|---|---|
| Fox Chase Cancer Center | OTHER |
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The purpose of the study is to understand patient interest in telehealth and digital tools for pre-test genetic education and/or disclosure of genetic test results. Participants will receive telehealth genetic counseling in the home and may be offered various digital tools to help with the counseling and testing process. These are optional and participants can still speak with a genetic counselor if they wish.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Uptake of Visit 1 | Participant completion of Visit 1 (yes/no) | Through 6 months |
| Uptake of Digital Visit 1 | Participant completion of digital intervention as an alternative for Visit 1 (yes/no) | Through 6 months |
| Uptake of genetic testing | Participant completion of genetic testing and received results/Visit 2 (yes/no) | Through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The KnowGene Scale | Change in Knowledge - Score Range = 0-16, Higher score = Better outcome | Through study completion, an average of 6 months |
| Test result recall | Recall of genetic testing results |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with personal or family history of cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Bradbury, MD | Contact | 215-615-3341 | angela.bradbury@pennmedicine.upenn.edu | |
| Kelsey Karpink | Contact | 215-662-3531 | kelsey.karpink@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angela Bradbury, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center at the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Through study completion, an average of 6 months |
| Impact of Events Scale (IES) | Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome | Through study completion, an average of 6 months |
| Satisfaction with genetic services | 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) | Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome | Through study completion, an average of 6 months |
| Decisional Regret Scale | Differences in decisional regret - Score Range = 5-25, Lower score = Better outcome | Through study completion, an average of 6 months |