Breast Cancer FemaleBRIM3NCT03339518
Breast Cancer Recurrence Risk Counseling
A study testing BRIM3 educational intervention and Wait List in people with Breast Cancer Female, run by West Virginia University at 2 sites in United States.
Trial summary
The number of breast cancer survivors is growing. Women with a personal history of breast cancer worry about their risk of getting cancer again. The current study will develop counseling about breast cancer recurrence risk and will also get an estimate of the preliminary impact of this counseling. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- BRIM3 educational intervention and Wait List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jul 2011to 31 Dec 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who (1) have a personal history of a single stage 0-2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic.
Who cannot join
- Women who are unable to read/write in English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40505
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: BRIM3: Breast Cancer Recurrence Risk Informational Materials Project
The number of breast cancer survivors is growing. Women with a personal history of breast cancer worry about their risk of getting cancer again. The current study will develop counseling about breast cancer recurrence risk and will also get an estimate of the preliminary impact of this counseling. The goal is to enable women to make better decisions about their treatment.
- Conditions
- Breast Cancer Female
- Being tested
- BRIM3 educational intervention, Wait List
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIM3 educational interventionBehavioural
Breast Cancer risk education and counseling
Wait ListBehavioural
Booklet at the end of study
| Study group | Role | What they receive |
|---|---|---|
| BRIM3 Educational intervention | Experimental | Individuals will receive a booklet and counseling about risk. Receives: Behavioral: BRIM3 educational intervention |
| Wait list Control | Other | At the completion of the study, individuals in the wait list condition will receive a booklet. Receives: Behavioral: Wait List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative Perceived Risk of Breast Cancer
Comparative perceived risk will be assessed with a comparative risk item (i.e., compared those of the same gender and race; Lipkus, CEBP 2000).
Measured: 6 months
Absolute Perceived Risk of Breast Cancer
Absolute perceived risk will be assessed with an absolute risk item to assess risk as a percentage (Kelly, PONC, 2005).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start25 Jul 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by West Virginia 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Principal investigator, Kimberly Kelly, West Virginia University
- Investigators
- Kimberly Kelly, PhD, Principal investigator, 304-293-1453
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339518
- Sponsor's protocol ID
- 1306056017
- Acronym
- BRIM3
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2017
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be available upon written request is appropriate human subjects protections are in place, and the request does not conflict with the aims of the study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIM3: Breast Cancer Recurrence Risk Informational Materials Project
- ClinicalTrials.gov ID
- NCT03339518
- Acronym / sponsor ID
- BRIM3 / 1306056017
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- 25 Jul 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 13 Nov 2017 (actual)
- 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 number of breast cancer survivors is growing. Women with a personal history of breast cancer worry about their risk of getting cancer again. The current study will develop counseling about breast cancer recurrence risk and will also get an estimate of the preliminary impact of this counseling. The goal is to enable women to make better decisions about their treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRIM3 Educational intervention | Experimental | Behavioral: BRIM3 educational interventionIndividuals will receive a booklet and counseling about risk. |
| Wait list Control | Other | Behavioral: Wait ListAt the completion of the study, individuals in the wait list condition will receive a booklet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who (1) have a personal history of a single stage 0-2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic.
Key exclusion criteria (1 listed)
- Women who are unable to read/write in English.
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 |
|---|---|---|
| BRIM3 educational interventionBreast Cancer risk education and counseling | Behavioural | BRIM3 Educational intervention |
| Wait ListBooklet at the end of study | Behavioural | Wait list Control |
Primary outcome
Comparative Perceived Risk of Breast Cancer
Time frame: 6 months
Comparative perceived risk will be assessed with a comparative risk item (i.e., compared those of the same gender and race; Lipkus, CEBP 2000).
Absolute Perceived Risk of Breast Cancer
Time frame: 6 months
Absolute perceived risk will be assessed with an absolute risk item to assess risk as a percentage (Kelly, PONC, 2005).
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 10 Oct 2019.
- Individual participant dataSharing planned: Undecided. De-identified data will be available upon written request is appropriate human subjects protections are in place, and the request does not conflict with the aims of the study.
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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.
Kimberly Kelly, PhD principal investigator
304-293-1453
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIM3 educational intervention and Wait List in people with Breast Cancer Female, run by West Virginia University at 2 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Comparative Perceived Risk of Breast Cancer (time frame: 6 months). 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?
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 10 Oct 2019.