Candidates for BRCA 1/2 Genetic TestingNCT01736345
A Study of the Communication of Genetic Test Results By Telephone: A Multi-Center Study
An observational study of Candidates for BRCA 1/2 Genetic Testing, run by Abramson Cancer Center at Penn Medicine at 5 sites in United States.
Trial summary
The overall goal of the proposed research is to evaluate psychosocial and behavioral outcomes (i.e.risks and benefits) of an innovative and efficient delivery model for genetic testing, telephone communication, as an alternative to in-person communication of genetic testing results to inform guidelines regarding the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Candidates for BRCA 1/2 Genetic Testing
- What is being tested?
- Genetic Providers, Visual Aids and Post-Disclosure Asessments
- How many people
- 289 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Dec 2012to Nov 2015
- 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: Engligh speaking Male or Female Completed in person pretest counseling Decided to have blood drawn for clinical BRCA 1/2 Age 18 or older
Who may be able to join
- Engligh speaking Male or Female Completed in person pretest counseling Decided to have blood drawn for clinical BRCA 1/2 Age 18 or older
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
MD Anderson Cancer Center at Cooper
Camden, New Jersey
The John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois
The University of Chicago
Chicago, Illinois
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Fox Chase Cancer Center
Philadelphia, Pennsylvania
About this study
Official title: A Study of the Communication of Genetic Test Results by Telephone: a Multi-center Study
The overall goal of the proposed research is to evaluate psychosocial and behavioral outcomes (i.e.risks and benefits) of an innovative and efficient delivery model for genetic testing, telephone communication, as an alternative to in-person communication of genetic testing results to inform guidelines regarding the delivery of genetic information in clinical medicine.
Read the detailed description
Basic science advances in genomics have provided great promise for improving human health and reducing the burden of cancer in the United States. The recent successes in genome-wide association studies (GWAS) and related technologies in identifying genetic changes associated with a variety of common diseases have fueled the rapidly growing field of personalized medicine. The promise of personalized medicine is the ability to tailor the treatment or screening of individual patients based on their genotype. Many have highlighted the urgent need for multidisciplinary translational research that focuses on how to advance gene discoveries into effective clinical applications. Genetic screening for cancer susceptibility, one application of personalized medicine, has become a standard evidence-based practice in cancer prevention. Given the complexity of genetic information and the potential social and psychological sequellae, two in-person visits (e.g. pre-test and post-test counseling) with genetic specialists are recommended for delivery of genetic testing for cancer susceptibility. With an increasing demand for genetic services, the two in-person visit delivery model presents barriers to widespread dissemination of genetic testing for disease susceptibility. Innovative delivery models for effective, efficient genetic risk communication that result in behavior change are needed. Telephone delivery of genetic services is one innovative and efficient delivery model that has the potential to expand genetic services to diverse clinical systems and address the insufficient genetic workforce as an increasing number of genetic applications enter clinical practice. While providers and patients identify advantages to telephone delivery of genetic services, they also recognize potential disadvantages particularly in the setting of a positive test result. Thus, evaluation of the psychosocial and behavioral impact of innovations to genetic service delivery (i.e. telephone communication) in diverse populations and among vulnerable subgroups are needed to optimize the health benefits, and minimize the risks of broad dissemination of clinical genetic testing for cancer susceptibility.
The goal of this research is to evaluate the psychological, behavioral and economic outcomes (i.e. risks and benefits) of an innovative and efficient delivery model of genetic services, telephone communication, as compared to the current standard, in-person communication of genetic test results. The investigators expect this research to inform evidence based practice guidelines and potentially change the paradigm of delivery of genetic services for disease susceptibility.
- Conditions
- Candidates for BRCA 1/2 Genetic Testing
- Being tested
- Genetic Providers, Visual Aids, Post-Disclosure Asessments, In-person Clinical Follow-Up, 6 Month and 12 Month Assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic ProvidersGenetic
Genetic providers (genetic counselors or nurses) will follow the standardized disclosure protocol for in-person and telephone disclosures whle completing a disclosure flow checklist.
Visual AidsOther
Visual aids targeted to facilitate communication of genetic test results were developed based on our preliminary studies and modified based on our initial pilot study.
Post-Disclosure AsessmentsOther
Within 72 hours of completion of disclosures, participants will be asked to complete post-disclosure survey again being the option to complete by the aforementioned means.
In-person Clinical Follow-UpOther
Participants who receive their test results in person will meet with a Physician, Physician Assistant or Nurse Practitioneras part of their in person disclosure session. Participants randomiZed to telephone disclosure will be recommendedto schedule an in-person clinical follow-up appointment with a Physician, Physician Assistant or Nurse Practitioner
6 Month and 12 Month AssessmentsOther
At 6 months and 12 months after disclosure participants will be asked to complete survey assessments.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Disclosure | Telephone Disclosure: Participants randomized to telephone disclosure will be asked to provide a personal identifier that the participant will be asked at the time of their telephone disclosure to ensure their identity. Receives: Genetic: Genetic Providers; Other: Visual Aids; Other: Post-Disclosure Asessments; Other: 6 Month and 12 Month Assessments | |
| In Person Disclosure | Individuals opting out of randomization but still willing to participate in the research will be placed in the self-select in-person arm. Receives: Genetic: Genetic Providers; Other: Visual Aids; Other: Post-Disclosure Asessments; Other: In-person Clinical Follow-Up; Other: 6 Month and 12 Month Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of telephone surveys completed
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 posted29 Nov 2012 (estimated)
- Study start3 Dec 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Candidates for BRCA 1/2 Genetic TestingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 289 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
- NCT01736345
- Sponsor's protocol ID
- UPCC 29112
- Status last verified
- Jul 2017
- First submitted
- 14 Nov 2012
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beri N, Patrick-Miller LJ, Egleston BL, Hall MJ, Domchek SM, Daly MB, Ganschow P, Grana G, Olopade OI, Fetzer D, Brandt A, Chambers R, Clark DF, Forman A, Gaber R, Gulden C, Horte J, Long J, Lucas T, Madaan S, Mattie K, McKenna D, Montgomery S, Nielsen S, Powers J, Rainey K, Rybak C, Savage M, Seelaus C, Stoll J, Stopfer JE, Yao XS, Bradbury AR. Preferences for in-person disclosure: Patients declining telephone disclosure characteristics and outcomes in the multicenter Communication Of GENetic Test Results by Telephone study. Clin Genet. 2019 Feb;95(2):293-301. doi: 10.1111/cge.13474. Epub 2018 Dec 7.
PubMed 30417332Bradbury AR, Patrick-Miller LJ, Egleston BL, Hall MJ, Domchek SM, Daly MB, Ganschow P, Grana G, Olopade OI, Fetzer D, Brandt A, Chambers R, Clark DF, Forman A, Gaber R, Gulden C, Horte J, Long JM, Lucas T, Madaan S, Mattie K, McKenna D, Montgomery S, Nielsen S, Powers J, Rainey K, Rybak C, Savage M, Seelaus C, Stoll J, Stopfer JE, Yao XS. Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results. J Natl Cancer Inst. 2018 Sep 1;110(9):985-993. doi: 10.1093/jnci/djy015.
PubMed 29490071
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Communication of Genetic Test Results by Telephone: a Multi-center Study
- ClinicalTrials.gov ID
- NCT01736345
- Acronym / sponsor ID
- UPCC 29112
- Conditions
- Candidates for BRCA 1/2 Genetic Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 3 Dec 2012 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 Nov 2012 (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 overall goal of the proposed research is to evaluate psychosocial and behavioral outcomes (i.e.risks and benefits) of an innovative and efficient delivery model for genetic testing, telephone communication, as an alternative to in-person communication of genetic testing results to inform guidelines regarding the delivery of genetic information in clinical medicine.
Detailed description
Basic science advances in genomics have provided great promise for improving human health and reducing the burden of cancer in the United States. The recent successes in genome-wide association studies (GWAS) and related technologies in identifying genetic changes associated with a variety of common diseases have fueled the rapidly growing field of personalized medicine. The promise of personalized medicine is the ability to tailor the treatment or screening of individual patients based on their genotype. Many have highlighted the urgent need for multidisciplinary translational research that focuses on how to advance gene discoveries into effective clinical applications. Genetic screening for cancer susceptibility, one application of personalized medicine, has become a standard evidence-based practice in cancer prevention. Given the complexity of genetic information and the potential social and psychological sequellae, two in-person visits (e.g. pre-test and post-test counseling) with genetic specialists are recommended for delivery of genetic testing for cancer susceptibility. With an increasing demand for genetic services, the two in-person visit delivery model presents barriers to widespread dissemination of genetic testing for disease susceptibility. Innovative delivery models for effective, efficient genetic risk communication that result in behavior change are needed. Telephone delivery of genetic services is one innovative and efficient delivery model that has the potential to expand genetic services to diverse clinical systems and address the insufficient genetic workforce as an increasing number of genetic applications enter clinical practice. While providers and patients identify advantages to telephone delivery of genetic services, they also recognize potential disadvantages particularly in the setting of a positive test result. Thus, evaluation of the psychosocial and behavioral impact of innovations to genetic service delivery (i.e. telephone communication) in diverse populations and among vulnerable subgroups are needed to optimize the health benefits, and minimize the risks of broad dissemination of clinical genetic testing for cancer susceptibility.
The goal of this research is to evaluate the psychological, behavioral and economic outcomes (i.e. risks and benefits) of an innovative and efficient delivery model of genetic services, telephone communication, as compared to the current standard, in-person communication of genetic test results. The investigators expect this research to inform evidence based practice guidelines and potentially change the paradigm of delivery of genetic services for disease susceptibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Disclosure | – | Genetic: Genetic Providers, Other: Visual Aids, Other: Post-Disclosure Asessments, Other: 6 Month and 12 Month AssessmentsTelephone Disclosure: Participants randomized to telephone disclosure will be asked to provide a personal identifier that the participant will be asked at the time of their telephone disclosure to ensure their identity. |
| In Person Disclosure | – | Genetic: Genetic Providers, Other: Visual Aids, Other: Post-Disclosure Asessments, Other: In-person Clinical Follow-Up, Other: 6 Month and 12 Month AssessmentsIndividuals opting out of randomization but still willing to participate in the research will be placed in the self-select in-person arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Engligh speaking Male or Female Completed in person pretest counseling Decided to have blood drawn for clinical BRCA 1/2 Age 18 or older
Key inclusion criteria (1 listed)
- Engligh speaking Male or Female Completed in person pretest counseling Decided to have blood drawn for clinical BRCA 1/2 Age 18 or older
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Genetic ProvidersGenetic providers (genetic counselors or nurses) will follow the standardized disclosure protocol for in-person and telephone disclosures whle completing a disclosure flow checklist. | Genetic | In Person Disclosure, Telephone Disclosure |
| Visual AidsVisual aids targeted to facilitate communication of genetic test results were developed based on our preliminary studies and modified based on our initial pilot study. | Other | In Person Disclosure, Telephone Disclosure |
| Post-Disclosure AsessmentsWithin 72 hours of completion of disclosures, participants will be asked to complete post-disclosure survey again being the option to complete by the aforementioned means. | Other | In Person Disclosure, Telephone Disclosure |
| In-person Clinical Follow-UpParticipants who receive their test results in person will meet with a Physician, Physician Assistant or Nurse Practitioneras part of their in person disclosure session. Participants randomiZed to telephone disclosure will be recommendedto schedule an in-person clinical follow-up appointment with a Physician, Physician Assistant or Nurse Practitioner | Other | In Person Disclosure |
| 6 Month and 12 Month AssessmentsAt 6 months and 12 months after disclosure participants will be asked to complete survey assessments. | Other | In Person Disclosure, Telephone Disclosure |
Primary outcome
Number of telephone surveys completed
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 27 Jul 2022.
- Derived from this study: PubMed 30417332Beri N, Patrick-Miller LJ, Egleston BL, Hall MJ, Domchek SM, Daly MB, Ganschow P, Grana G, Olopade OI, Fetzer D, Brandt A, Chambers R, Clark DF, Forman A, Gaber R, Gulden C, Horte J, Long J, Lucas T, Madaan S, Mattie K, McKenna D, Montgomery S, Nielsen S, Powers J, Rainey K, Rybak C, Savage M, Seelaus C, Stoll J, Stopfer JE, Yao XS, Bradbury AR. Preferences for in-person disclosure: Patients declining telephone disclosure characteristics and outcomes in the multicenter Communication Of GENetic Test Results by Telephone study. Clin Genet. 2019 Feb;95(2):293-301. doi: 10.1111/cge.13474. Epub 2018 Dec 7.
- Derived from this study: PubMed 29490071Bradbury AR, Patrick-Miller LJ, Egleston BL, Hall MJ, Domchek SM, Daly MB, Ganschow P, Grana G, Olopade OI, Fetzer D, Brandt A, Chambers R, Clark DF, Forman A, Gaber R, Gulden C, Horte J, Long JM, Lucas T, Madaan S, Mattie K, McKenna D, Montgomery S, Nielsen S, Powers J, Rainey K, Rybak C, Savage M, Seelaus C, Stoll J, Stopfer JE, Yao XS. Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results. J Natl Cancer Inst. 2018 Sep 1;110(9):985-993. doi: 10.1093/jnci/djy015.
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidates for BRCA 1/2 Genetic Testing, run by Abramson Cancer Center at Penn Medicine at 5 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 1 inclusion and 1 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Number of telephone surveys completed (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01736345, which also lists 2 linked publications.
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 27 Jul 2022.