Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT03934606
Collaborator
(none)
500
1
60
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Genetic testing for hereditary predisposition

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model: A Pilot Study of Patient Outcomes
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. baseline to post-results change in distress levels [1-3months]

    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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn Medicine - University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03934606
Other Study ID Numbers:
  • UPCC 15917
  • 828314
First Posted:
May 2, 2019
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022