Breast Density, Breast Cancer PreventionNCT02986360
Informed Implementation of Breast Density Reporting
A study testing Vidscrip educational video in people with Breast Density, Breast Cancer Prevention, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
1. To develop brief informational videos, Vidscrips, that can be sent to women following their mammogram to provide personalized information that integrates breast density with overall breast cancer risk, and provides information about additional care recommendations and talking tips for conversations with the health… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Density, Breast Cancer Prevention
- What is being tested?
- Vidscrip educational video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Nov 2017
- 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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing screening mammography at participating hospital facility
- normal mammogram result
- no prior history of Ductal carcinoma in situ (DCIS) or invasive breast cancer
- must have email account
Who cannot join
- non-English speaking
- prior history of Ductal Carcinoma in situ (DCIS) or invasive breast cancer
- no email
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
- To develop brief informational videos, Vidscrips, that can be sent to women following their mammogram to provide personalized information that integrates breast density with overall breast cancer risk, and provides information about additional care recommendations and talking tips for conversations with the health care providers.
- To test the effectiveness of this tool in a trial of 300 women undergoing mammography. The investigators hypothesize that individuals in the intervention arm (vs. those in the standard care arm who receive a letter with the language required by the legislation) will have more accurate knowledge of their overall risk of breast cancer, their Mammographic Breast Density (MBD) result, more appropriate observed and intended use of additional screening [i.e., use of screening Magnetic Resonance Imaging (MRI) will be reserved only for women at high risk of breast cancer], better satisfaction with their episode of breast cancer screening, less decisional conflict about their personal decision for any additional evaluation, and less worry about breast cancer.
- Conditions
- Breast Density, Breast Cancer Prevention
- Being tested
- Vidscrip educational video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vidscrip educational videoBehavioural
Vidscrip educational video provide to women
| Study group | Role | What they receive |
|---|---|---|
| Vidscrip educational video | Active comparator | Patients receive Vidscrip education video discussing breast density in the context of their normal mammogram result Receives: Behavioral: Vidscrip educational video |
| Standard of care | No intervention | Receive normal mammogram result and standard letter about breast density without any additional educational tools to contextualize breast density |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of overall breast cancer risk
electronic questionnaire developed by research staff
Measured: 1 month
Knowledge of breast density
electronic questionnaire developed by research staff
Measured: 1 month
Secondary outcomes (1)
Observed use of additional screening
Additional screening tests (ultrasound or MRI) extracted from patient's electronic medical record
Measured: 9 months of index mammogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start1 May 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Density, Breast Cancer PreventionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer S. Haas, MD, Brigham and Women's Hospital
- Investigators
- Jennifer S Haas, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986360
- Sponsor's protocol ID
- 2016P001411
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2016
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haas JS, Giess CS, Harris KA, Ansolabehere J, Kaplan CP. Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification. J Gen Intern Med. 2019 Apr;34(4):591-597. doi: 10.1007/s11606-018-4622-4. Epub 2018 Aug 8.
PubMed 30091121
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Implementation of Breast Density Reporting
- ClinicalTrials.gov ID
- NCT02986360
- Acronym / sponsor ID
- 2016P001411
- Conditions
- Breast Density, Breast Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 8 Dec 2016 (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.
- To develop brief informational videos, Vidscrips, that can be sent to women following their mammogram to provide personalized information that integrates breast density with overall breast cancer risk, and provides information about additional care recommendations and talking tips for conversations with the health care providers.
- To test the effectiveness of this tool in a trial of 300 women undergoing mammography. The investigators hypothesize that individuals in the intervention arm (vs. those in the standard care arm who receive a letter with the language required by the legislation) will have more accurate knowledge of their overall risk of breast cancer, their Mammographic Breast Density (MBD) result, more appropriate observed and intended use of additional screening [i.e., use of screening Magnetic Resonance Imaging (MRI) will be reserved only for women at high risk of breast cancer], better satisfaction with their episode of breast cancer screening, less decisional conflict about their personal decision for any additional evaluation, and less worry about breast cancer.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vidscrip educational video | Active comparator | Behavioral: Vidscrip educational videoPatients receive Vidscrip education video discussing breast density in the context of their normal mammogram result |
| Standard of care | No intervention | –Receive normal mammogram result and standard letter about breast density without any additional educational tools to contextualize breast density |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergoing screening mammography at participating hospital facility
- normal mammogram result
- no prior history of Ductal carcinoma in situ (DCIS) or invasive breast cancer
- must have email account
Key exclusion criteria (3 listed)
- non-English speaking
- prior history of Ductal Carcinoma in situ (DCIS) or invasive breast cancer
- no email
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 |
|---|---|---|
| Vidscrip educational videoVidscrip educational video provide to women | Behavioural | Vidscrip educational video |
Primary outcome
Knowledge of overall breast cancer risk
Time frame: 1 month
electronic questionnaire developed by research staff
Knowledge of breast density
Time frame: 1 month
electronic questionnaire developed by research staff
1 secondary outcome
Observed use of additional screening
Time frame: 9 months of index mammogram
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 21 Sep 2018.
- Derived from this study: PubMed 30091121Haas JS, Giess CS, Harris KA, Ansolabehere J, Kaplan CP. Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification. J Gen Intern Med. 2019 Apr;34(4):591-597. doi: 10.1007/s11606-018-4622-4. Epub 2018 Aug 8.
- Individual participant dataSharing planned: No
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.
Jennifer S Haas, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vidscrip educational video in people with Breast Density, Breast Cancer Prevention, run by Brigham and Women's Hospital 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 4 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 21 Sep 2018. 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 of overall breast cancer risk (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT02986360, which also lists 1 linked publication.
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 21 Sep 2018; AzTrials last refreshed its copy on 3 Nov 2026.