NCT02517554

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

2.6 years

First QC Date

August 5, 2015

Last Update Submit

January 18, 2024

Conditions

Keywords

meet National Comprehensive Cancer Network® criteria for cancer genetic testing for breast, ovarian and colorectal cancers

Outcome Measures

Primary Outcomes (1)

  • Completion of Surveys

    3 years

Study Arms (3)

Remote cancer genetic services by videoconference

Behavioral: Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community site

Remote cancer genetic services by telephone

Behavioral: Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community site

Usual Care

Behavioral: Patient receives written information on how to find genetic services in their area

Interventions

Baseline and follow up survey

Remote cancer genetic services by videoconference

Baseline and follow up surveys

Remote cancer genetic services by telephone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Candidate for genetic testing for BRCA or colon cancer related genes

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Union Hospital

Elkton, Maryland, 21921, United States

Location

Cape Regional Medical Center

Cape May Court House, New Jersey, 08210, United States

Location

Kennedy Health

Sewell, New Jersey, 08080, United States

Location

Shore Cancer Center

Somers Point, New Jersey, 08244, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Drexel Cancer Care at Hahnemann

Philadelphia, Pennsylvania, 19102, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Angela Bradbury, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 7, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2018

Study Completion

November 1, 2019

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations