Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

NCT ID: NCT03934606

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1488 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-01-31

Brief Summary

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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

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Conditions

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Pancreas Cancer Prostate Cancer Hereditary Cancer Genetic Predisposition to Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavioral Assessments

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Penn Medicine - University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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828314

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 15917

Identifier Type: -

Identifier Source: org_study_id

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