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出境医 / 临床实验 / Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

Study Description
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 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.

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

Study Design
Layout table for study information
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 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Outcome Measures
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


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date February 13, 2019
First Posted Date May 2, 2019
Last Update Posted Date February 12, 2021
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2019)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model
Official Title Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model: A Pilot Study of Patient Outcomes
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 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients seen at Penn Medicine with a pancreas cancer or metastatic prostate cancer.
Condition
  • Pancreas Cancer
  • Prostate Cancer
  • Hereditary Cancer
  • Genetic Predisposition to Disease
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 30, 2019) 		500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03934606
Other Study ID Numbers 828314
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Pennsylvania
Verification Date February 2021

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