Breast CancerNCT02133703
Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility
A study testing Enhanced Internet DA, Internet DA and Enhanced Print DA in people with Breast Cancer and Ovarian Cancer, run by Georgetown University at 1 site in United States.
Trial summary
This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Ovarian Cancer
- What is being tested?
- Enhanced Internet DA, Internet DA and Enhanced Print DA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 1 Jul 2022
- Phase
- Interventional
- 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 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergo BRCA1/2 genetic counseling and testing at one of four study sites
- Receive positive or uninformative test results
- English speaking
Who cannot join
- Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
- Previous bilateral mastectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results
This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.
- Conditions
- Breast Cancer, Ovarian Cancer
- Being tested
- Enhanced Internet DA, Internet DA, Enhanced Print DA, Print DA, Inconclusive Results DA
- Keywords
- Genetic counseling, genetic testing, BRCA1, BRCA2, Hereditary breast cancer, Hereditary ovarian cancer
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Breast Cancer, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Internet DABehavioural
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
Internet DABehavioural
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options.
Enhanced Print DABehavioural
BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
Print DABehavioural
BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
Inconclusive Results DABehavioural
Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
| Study group | Role | What they receive |
|---|---|---|
| Mutation Carrier: Enhanced Internet DA | Experimental | BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. Receives: Behavioral: Enhanced Internet DA |
| Mutation Carrier: Internet DA | Experimental | BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool. Receives: Behavioral: Internet DA |
| Mutation Carrier: Enhanced Print DA | Active comparator | BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool. Receives: Behavioral: Enhanced Print DA |
| Mutation Carrier: Print DA | Active comparator | BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool. Receives: Behavioral: Print DA |
| Inconclusive Results: DA | Experimental | Participants who receive inconclusive results who are randomized to this arm will have access to an Internet decision tool designed to facilitate management decision making Receives: Behavioral: Inconclusive Results DA |
| Inconclusive Results: Usual care | No intervention | Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
Knowledge of risk management options.
Measured: 1-month post randomization
Decision Conflict
Decisional Conflict Scale
Measured: 1-month post-randomization
Decision Satisfaction
Satisfaction with Decision Scale
Measured: 12-months post-randomization
Psychological Distress
Measured: 1-month post randomization
Health Related Quality of Life
SF-12
Measured: 12-months post randomization
Utilization of breast and ovarian cancer risk management options
We will assess uptake of the following risk management strategies:
- Risk reducing surgery (mastectomy and oophorectomy)
- Chemoprevention
- Breast and ovarian cancer screening
Measured: 12-months post-randomization
Secondary outcomes (3)
Knowledge
Knowledge of risk management options
Measured: 3-months post randomization
Psychological Distress
Measured: 3-months post-randomization
Decisional Conflict
Decisional Conflict Scale
Measured: 3-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startOct 2015
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
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 Georgetown UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Marc D Schwartz, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133703
- Sponsor's protocol ID
- 2010-611
- Other IDs
- R01CA135179-01, R01HG005055
- Status last verified
- Sep 2022
- First submitted
- 9 Apr 2014
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results
- ClinicalTrials.gov ID
- NCT02133703
- Acronym / sponsor ID
- 2010-611
- Conditions
- Breast Cancer, Ovarian Cancer
- Keywords
- Genetic counseling, genetic testing, BRCA1, BRCA2, Hereditary breast cancer, Hereditary ovarian cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)
- Study start
- Oct 2015
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 8 May 2014 (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.
This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Mutation Carrier: Enhanced Internet DA | Experimental | Behavioral: Enhanced Internet DABRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. |
| Mutation Carrier: Internet DA | Experimental | Behavioral: Internet DABRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool. |
| Mutation Carrier: Enhanced Print DA | Active comparator | Behavioral: Enhanced Print DABRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool. |
| Mutation Carrier: Print DA | Active comparator | Behavioral: Print DABRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool. |
| Inconclusive Results: DA | Experimental | Behavioral: Inconclusive Results DAParticipants who receive inconclusive results who are randomized to this arm will have access to an Internet decision tool designed to facilitate management decision making |
| Inconclusive Results: Usual care | No intervention | –Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergo BRCA1/2 genetic counseling and testing at one of four study sites
- Receive positive or uninformative test results
- English speaking
Key exclusion criteria (2 listed)
- Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment
- Previous bilateral mastectomy
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 |
|---|---|---|
| Enhanced Internet DABRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options. | Behavioural | Mutation Carrier: Enhanced Internet DA |
| Internet DABRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options. | Behavioural | Mutation Carrier: Internet DA |
| Enhanced Print DABRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options. | Behavioural | Mutation Carrier: Enhanced Print DA |
| Print DABRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options. | Behavioural | Mutation Carrier: Print DA |
| Inconclusive Results DAWomen who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options. | Behavioural | Inconclusive Results: DA |
Primary outcome
Knowledge
Time frame: 1-month post randomization
Knowledge of risk management options.
Decision Conflict
Time frame: 1-month post-randomization
Decisional Conflict Scale
Decision Satisfaction
Time frame: 12-months post-randomization
Satisfaction with Decision Scale
Psychological Distress
Time frame: 1-month post randomization
Health Related Quality of Life
Time frame: 12-months post randomization
SF-12
Utilization of breast and ovarian cancer risk management options
Time frame: 12-months post-randomization
We will assess uptake of the following risk management strategies: 1. Risk reducing surgery (mastectomy and oophorectomy) 2. Chemoprevention 3. Breast and ovarian cancer screening
3 secondary outcomes
Knowledge
Time frame: 3-months post randomization
Psychological Distress
Time frame: 3-months post-randomization
Decisional Conflict
Time frame: 3-months post-randomization
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 14 Oct 2022.
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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.
Marc D Schwartz, PhD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Internet DA, Internet DA and Enhanced Print DA in people with Breast Cancer and Ovarian Cancer, run by Georgetown University at 1 site 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 2 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Knowledge (time frame: 1-month post randomization). The study lists 6 primary outcomes in all. 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 14 Oct 2022.