Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

Study Overview
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Brief Summary
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To evaluate an alternative clinical genetics cancer care delivery model, using non-genetic providers to introduce and order genetic testing. 250 prostate and 250 pancreatic patients will be recruiting. They will undergo genetic testing and complete study questionnaires. Results from this pilot study will be used to inform the strategies used by the Clinical Risk Evaluation Program (CREP) Genetic Counelors (CGS) and GI/GU physicians to deliver genetic testing and return genetic risk information to patients with prostate or pancreatic cancer.

Official Title
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Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model: A Pilot Study of Patient Outcomes

Conditions
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Pancreas Cancer, Prostate Cancer, Hereditary Cancer, Genetic Predisposition to Disease

Intervention / Treatment
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* Behavioral: Genetic testing for hereditary predisposition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Penn patient age 18 years or older. Diagnosed with prostate cancer or pancreas cancer. Deemed to be clinically appropriate for multiplex genetic testing by their Urologic Cancer Program (GU) physician or Gastrointestinal Cancer Program (GI) physician at the Abramson Cancer Agreed to receive clinical multiplex genetic testing from their physician. English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Exclusion Criteria: • Patients who do not or will not receive their ongoing cancer care at Penn Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation. Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Genetic testing for hereditary predisposition|Change in distress levels (HADS-Anxiety) from Baseline to Assessments #2 and #3, measured as an effect size among participants who receive a pathogenic variant(s), no pathogenic variant(s), and variant(s) of uncertain significance|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline to post-results change in distress levels | Change in distress levels (HADS-Anxiety) from Baseline to Time point #2 (post-disclosure) measured as an effect size among participants who receive a pathogenic variant(s), no pathogenic variant(s), and variant(s) of uncertain significance | 1-3months | 
| baseline to post-results change in distress levels | Change in distress levels (HADS-Anxiety) from Baseline to Time point #3 (3 months post-disclosure) measured as an effect size among participants who receive a pathogenic variant(s), no pathogenic variant(s), and variant(s) of uncertain significance | 3 months |