A Study Of TeleGenetics Versus Usual Care To Increase Access To Cancer Genetic Services

January 18, 2024 updated by: Abramson Cancer Center at Penn Medicine

A Randomized Study Of TeleGenetics Versus Usual Care To Increase Access To Cancer Genetic Services

The goal of this research is to evaluate the relative advantage of remote counseling over usual care in community health practices without access to genetic services. We will evaluate ability of remote telemedicine, referred to going forward as TeleGenetic services (phone or videoconferencing), to increase uptake of genetic testing and identification of genetic carriers compared to usual care. Secondly, we will evaluate the advantages of videoconferencing over telephone for delivery of remote genetic services and the short-term and longitudinal outcomes of TeleGenetic services in socio-demographically diverse patients in community practices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Union Hospital
    • New Jersey
      • Cape May Court House, New Jersey, United States, 08210
        • Cape Regional Medical Center
      • Sewell, New Jersey, United States, 08080
        • Kennedy Health
      • Somers Point, New Jersey, United States, 08244
        • Shore Cancer Center
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Gettysburg Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel Cancer Care at Hahnemann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Candidate for genetic testing for BRCA or colon cancer related genes

Description

Inclusion Criteria:

  1. Eligible participants will include adult men and women (aged 18 and older) who can understand and communicate in English
  2. meet National Comprehensive Cancer Network® criteria for cancer genetic testing for breast, ovarian or colorectal cancers
  3. have insurance coverage for genetic testing.

Exclusion Criteria:

  1. Under 18 years old - professional guidelines do not recommend genetic testing for cancer risk in minors.
  2. Does not speak English.
  3. Does not have insurance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Usual Care
Behavioral: Patient receives written information on how to find genetic services in their area
Baseline and follow up surveys
Remote cancer genetic services by videoconference
Behavioral: Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community site
Baseline and follow up survey
Remote cancer genetic services by telephone
Behavioral: Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community site
Baseline and follow up surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion of Surveys
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Angela Bradbury, MD, Abramson Cancer Center at Penn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimated)

August 7, 2015

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 09115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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