Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

NCT03934606 | Completed

• 2 other identifiers: UPCC 15917828314
• Study Type: observational
• Target: 1,488
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer; Prostate Cancer; Hereditary Cancer; Genetic Predisposition to Disease

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Genetic testing for hereditary predisposition BEHAVIORAL

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

Also known as: Behavioral Assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen at Penn Medicine with a pancreas cancer or metastatic prostate cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Penn Medicine - University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Prostatic Neoplasms; Genetic Predisposition to Disease

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: May 2, 2019
• Study Start: January 1, 2018
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (1)