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Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03934606
Enrollment
1488
Registered
2019-05-02
Start date
2018-01-01
Completion date
2025-01-31
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALGenetic 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

Sponsors

Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
baseline to post-results change in distress levels1-3monthsChange 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026