Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03934606
• Other study ID #: UPCC 15917
• Secondary ID: 828314
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition to Disease
• Hereditary Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Prostate Cancer

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

Locations

Country	Name	City	State
United States	Penn Medicine - University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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