Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

Completed

• Conditions: Hereditary Cancer; Prostate Cancer; Genetic Predisposition to Disease; Pancreas Cancer

• Registration Number: NCT03934606
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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 available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1488

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
baseline to post-results change in distress levels	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

Trial Locations

Locations (1)

Penn Medicine - University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States