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Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

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ClinicalTrials.gov Identifier: NCT03934606
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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 CREP CGS and GI/GU physicians to deliver genetic testing and return genetic risk information to patients with prostate or pancreatic cancer.

Condition or disease Intervention/treatment
Pancreas Cancer Prostate Cancer Hereditary Cancer Genetic Predisposition to Disease Behavioral: Genetic testing for hereditary predisposition

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model: A Pilot Study of Patient Outcomes
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing


Intervention Details:
  • 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
    Other Name: Behavioral Assessments


Primary Outcome Measures :
  1. baseline to post-results change in distress levels [ Time Frame: 1-3months ]
    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

  2. baseline to post-results change in distress levels [ Time Frame: 3 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at Penn Medicine with a pancreas cancer or metastatic prostate cancer.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934606


Locations
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United States, Pennsylvania
Penn Medicine - University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Susan Domchek, MD    215-615-3360    susan.domchek@pennmedicine.upenn.edu   
Contact: Heather Symecko, MPH    2156622770    hsymecko@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03934606     History of Changes
Other Study ID Numbers: 828314
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Disease Susceptibility
Genetic Predisposition to Disease
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes