Breast CancerNCT02517554
A Study Of TeleGenetics Versus Usual Care To Increase Access To Cancer Genetic Services
An observational study of Breast Cancer and Ovarian Cancer, run by Abramson Cancer Center at Penn Medicine at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Colorectal Cancer
- What is being tested?
- Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community site, Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community site and Patient receives written information on how to find genetic services in their area
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2015to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Candidate for genetic testing for BRCA or colon cancer related genes
Who may be able to join
- 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.
Who cannot join
- Under 18 years old - professional guidelines do not recommend genetic testing for cancer risk in minors.
- Does not speak English.
- Does not have insurance.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cape Regional Medical Center
Cape May Court House, New Jersey, 08210
Union Hospital
Elkton, Maryland, 21921
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Drexel Cancer Care at Hahnemann
Philadelphia, Pennsylvania, 19102
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kennedy Health
Sewell, New Jersey, 08080
Shore Cancer Center
Somers Point, New Jersey, 08244
About this study
Official title: 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.
- Conditions
- Breast Cancer, Ovarian Cancer, Colorectal Cancer
- Being tested
- Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community site, Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community site, Patient receives written information on how to find genetic services in their area
- Keywords
- meet National Comprehensive Cancer Network® criteria for cancer genetic testing for breast, ovarian and colorectal cancers
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community siteBehavioural
Baseline and follow up survey
Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community siteBehavioural
Baseline and follow up surveys
Patient receives written information on how to find genetic services in their areaBehavioural
Baseline and follow up surveys
| Study group | Role | What they receive |
|---|---|---|
| Remote cancer genetic services by videoconference | Not described Receives: Behavioral: Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community site | |
| Remote cancer genetic services by telephone | Not described Receives: Behavioral: Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community site | |
| Usual Care | Not described Receives: Behavioral: Patient receives written information on how to find genetic services in their area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Surveys
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Bradbury, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517554
- Sponsor's protocol ID
- UPCC 09115
- Status last verified
- Jan 2024
- First submitted
- 5 Aug 2015
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Of TeleGenetics Versus Usual Care To Increase Access To Cancer Genetic Services
- ClinicalTrials.gov ID
- NCT02517554
- Acronym / sponsor ID
- UPCC 09115
- Conditions
- Breast Cancer, Ovarian Cancer, Colorectal Cancer
- Keywords
- meet National Comprehensive Cancer Network® criteria for cancer genetic testing for breast, ovarian and colorectal cancers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Candidate for genetic testing for BRCA or colon cancer related genes
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Under 18 years old - professional guidelines do not recommend genetic testing for cancer risk in minors.
- Does not speak English.
- Does not have insurance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community siteBaseline and follow up survey | Behavioural | Remote cancer genetic services by videoconference |
| Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community siteBaseline and follow up surveys | Behavioural | Remote cancer genetic services by telephone |
| Patient receives written information on how to find genetic services in their areaBaseline and follow up surveys | Behavioural | Usual Care |
Primary outcome
Completion of Surveys
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Bradbury, MD principal investigator
Abramson Cancer Center at Penn Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Ovarian Cancer, run by Abramson Cancer Center at Penn Medicine at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Surveys (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.