Breast CancerNCT00347568
BC-DAISY: A Breast Cancer Decision Aid System
A study testing TX-plore in people with Breast Cancer, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The purpose of this study is to develop a web-based decision aid to help women at high risk for breast cancer make informed breast cancer prevention choices. These choices include chemoprevention, surgery, genetic counseling, or regular screening in accordance with recommended guidelines. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TX-plore
- Type of treatment
- Medical device
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between the ages of 21 - 75
- at least one first degree relative with breast cancer or a Gail Model score signifying high risk
- female
- having had contact with a PCP (physician or nurse practitioner)within the last year
- being a patient at a participating clinic (for usability and pilot study)
Who cannot join
- Inability to give informed, voluntary consent
- History of breast cancer or LCIS
- Language, vision, or reading difficulties, or non-English speaking
- Pregnancy
- women over 75 because of the lack of data guiding the impact of preventive treatments among this age group.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
The purpose of this study is to develop a web-based decision aid to help women at high risk for breast cancer make informed breast cancer prevention choices. These choices include chemoprevention, surgery, genetic counseling, or regular screening in accordance with recommended guidelines.
Read the detailed description
Decisions about breast cancer are complex and preference-based. Existing decision aids that help identify women eligible for tamoxifen based on their breast cancer risk, such as the Breast Cancer Risk Assessment Tool (BCRAT), were not designed to identify women's risks for side-effects, her preferences for outcomes affected by treatment, nor the net balance of benefits and risks. It is possible to predict the risks of side effects of treatments according to patient characteristics, using patient-specific models.Our goal is to develop a decision aid, TXplore, that rates the overall benefit:risk profiles of various breast cancer prevention strategies according to a woman's risks for breast cancer, side-effects, and preferences. Each user will receive a customized report card grading each available prevention option, using preference-weighted risk:benefit grades; users can also explore personalized feedback from the program. Our hypotheses are that this tool can improve the implementation of appropriate prevention strategies, promote risk reduction behavior, and improve PCP's ability to identify and counsel high risk women.We propose building on modeling techniques that link the benefits and risks of preventive strategies to patient characteristics and preferences. We now seek to conduct focus groups and usability tests on end-users to optimize the design of the prototype TXplore.
The Specific Aims are:
- To optimize the design of TXplore by focus groups conducted among diverse high-risk women and PCPs to a) identify the domains driving decisions about prevention and explore the framing of questions comparing the relative importance of one domain to another, synthesizing this information as preference trade-off questions; and b) explore the framing of risk:benefit grades and personalized feedback.
- To assess the comprehensibility of preference trade-off questions by testing each question on a diverse sample of 50 high-risk women, revising and retesting.
- To assess the usability of TXplore for patients and PCPsThe successful completion of this project will produce a novel tool for counseling women about their individual benefits and risks of breast cancer prevention strategies. It will be the first tool of its kind to integrate individual patient risks and preferences into decision support.
- Conditions
- Breast Cancer
- Being tested
- TX-plore
- Keywords
- decision aids, high risk, breast cancer, breast cancer prevention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TX-ploreDevice
PI has terminated at institution and there is no one available to report.
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability feedback on new decision aid for women at high risk for breast cancer from patients and physicians.
Measured: 9/01/06-8/31/07
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2007
- Study completionDec 2009
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.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nananda Col, MD, MPP, MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347568
- Sponsor's protocol ID
- 0312-05
- Status last verified
- Jun 2012
- First submitted
- 29 Jun 2006
- Last updated
- 5 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BC-DAISY: A Breast Cancer Decision Aid System
- ClinicalTrials.gov ID
- NCT00347568
- Acronym / sponsor ID
- 0312-05
- Conditions
- Breast Cancer
- Keywords
- decision aids, high risk, breast cancer, breast cancer prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Jul 2006 (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 purpose of this study is to develop a web-based decision aid to help women at high risk for breast cancer make informed breast cancer prevention choices. These choices include chemoprevention, surgery, genetic counseling, or regular screening in accordance with recommended guidelines.
Detailed description
Decisions about breast cancer are complex and preference-based. Existing decision aids that help identify women eligible for tamoxifen based on their breast cancer risk, such as the Breast Cancer Risk Assessment Tool (BCRAT), were not designed to identify women's risks for side-effects, her preferences for outcomes affected by treatment, nor the net balance of benefits and risks. It is possible to predict the risks of side effects of treatments according to patient characteristics, using patient-specific models.Our goal is to develop a decision aid, TXplore, that rates the overall benefit:risk profiles of various breast cancer prevention strategies according to a woman's risks for breast cancer, side-effects, and preferences. Each user will receive a customized report card grading each available prevention option, using preference-weighted risk:benefit grades; users can also explore personalized feedback from the program. Our hypotheses are that this tool can improve the implementation of appropriate prevention strategies, promote risk reduction behavior, and improve PCP's ability to identify and counsel high risk women.We propose building on modeling techniques that link the benefits and risks of preventive strategies to patient characteristics and preferences. We now seek to conduct focus groups and usability tests on end-users to optimize the design of the prototype TXplore.
The Specific Aims are:
- To optimize the design of TXplore by focus groups conducted among diverse high-risk women and PCPs to a) identify the domains driving decisions about prevention and explore the framing of questions comparing the relative importance of one domain to another, synthesizing this information as preference trade-off questions; and b) explore the framing of risk:benefit grades and personalized feedback.
- To assess the comprehensibility of preference trade-off questions by testing each question on a diverse sample of 50 high-risk women, revising and retesting.
- To assess the usability of TXplore for patients and PCPsThe successful completion of this project will produce a novel tool for counseling women about their individual benefits and risks of breast cancer prevention strategies. It will be the first tool of its kind to integrate individual patient risks and preferences into decision support.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between the ages of 21 - 75
- at least one first degree relative with breast cancer or a Gail Model score signifying high risk
- female
- having had contact with a PCP (physician or nurse practitioner)within the last year
- being a patient at a participating clinic (for usability and pilot study)
Key exclusion criteria (5 listed)
- Inability to give informed, voluntary consent
- History of breast cancer or LCIS
- Language, vision, or reading difficulties, or non-English speaking
- Pregnancy
- women over 75 because of the lack of data guiding the impact of preventive treatments among this age group.
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 |
|---|---|---|
| TX-plorePI has terminated at institution and there is no one available to report. | Device | – |
Primary outcome
Usability feedback on new decision aid for women at high risk for breast cancer from patients and physicians.
Time frame: 9/01/06-8/31/07
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 5 Jun 2012.
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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.
Nananda Col, MD, MPP, MPH principal investigator
Rhode Island 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 TX-plore in people with Breast Cancer, run by Rhode Island 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 5 inclusion and 5 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 5 Jun 2012. 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?
Usability feedback on new decision aid for women at high risk for breast cancer from patients and physicians. (time frame: 9/01/06-8/31/07). 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 5 Jun 2012.