High Risk for Breast CancerNCT00906321
Facilitating Web-based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
A study testing Web-Based Decision Support in people with High Risk for Breast Cancer and Risk Reduction Behavior, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Chemoprevention is the use of preventive medications to reduce the risk of breast cancer for women who are at a high risk of developing the disease. Although the treatment has shown effectiveness in preventing cancer development, chemoprevention is notably underutilized even by women who are at a high risk… Read more about this study
- Who is it for?
- Ages 35 to 100 years, women only
- Conditions the study is for
- High Risk for Breast Cancer, Risk Reduction Behavior
- What is being tested?
- Web-Based Decision Support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2009to 26 May 2010
- 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 35 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Concurrent participation in another cancer chemoprevention study
- Prior history of cancer, other than cervical carcinoma in situ or non-melanoma skin cancer
- Ever taken tamoxifen or raloxifene
- Age less than 35
- Unable to communicate in English verbally and in writing
- No computer with internet access
- No email account
- No telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Facilitating Web-Based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
Background:
- Chemoprevention is the use of preventive medications to reduce the risk of breast cancer for women who are at a high risk of developing the disease. Although the treatment has shown effectiveness in preventing cancer development, chemoprevention is notably underutilized even by women who are at a high risk of developing breast cancer.
- Researchers are interested in determining if better decision support mechanisms, such as interactive Web sites, can help to overcome some of the barriers to chemoprevention.
Read more
Objectives:
- To develop and test a prototype Web-based module that will provide decision support to women who are considering chemoprevention for breast cancer.
Eligibility:
- Women 35 years of age and older who are at high risk for breast cancer and whose doctor has recommended chemoprevention (either Tamoxifen or Raloxifene), and who have no other history of cancer (apart from non-melanoma skin cancer or precancerous cervical lesions).
- Participants must have a working e-mail address and access to a computer with internet access and a telephone.
Design:
- Participants who are considering chemoprevention will be randomized to a Web-based decision support module or standard care online information resources.
- Participation lasts two months and involves using the online resources provided and filling out questionnaires two times during the study (at the beginning and the end).
The first time will be at the begin of the study.
- No medical treatments are offered as a part of this study
Read the detailed description
BACKGROUND:
- Breast cancer chemoprevention has been notably underutilized.
- Barriers to integrating breast cancer risk reducing measures include: lack of time, low priority of risk reduction in comparison to treatment, the need to personalize risks and benefits of chemoprevention, and the need for resources/information necessary for women to make informed decisions.
- Access to quality decision support resources to facilitate making informed, preference-sensitive decisions about chemoprevention may provide a mechanism to overcome some of the current barriers to chemoprevention utilization.
OBJECTIVES:
- Develop and refine a web-based patient decision support module for high-risk women making a decision about breast cancer chemoprevention.
- Conduct a randomized study of TACHD decision support versus standard care online information support to evaluate the impact of the chemoprevention module of the TACHD decision support intervention.
ELIGIBILITY:
- Women with no history of cancer other than cervical carcinoma in situ or non-melanoma skin cancer
- High risk for breast cancer based on at least one of the following:
- Gail score > 1.67
- History of atypical hyperplasia (either ductal or lobular)
- History of lobular carcinoma in situ
- Documentation of a deleterious BRCA1 or BRCA2 mutation
- Considering a decision about chemoprevention with tamoxifen or raloxifene
- Access to an IBM-compatible or MacIntosh personal computer with broadband Internet access
- Access to an email account
- Access to a telephone
- Aged 35 or older
- Able to communicate in English verbally and in writing
DESIGN:
- The project will be guided by the Cognitive-Social Health Information Processing (CSHIP) model overall, and incorporate the Ottawa Decision Support. Framework (ODSF) in one consistent decision support process.
- Testing of the chemoprevention decision support module will be conducted in a two-group pre- post-test experimental design with 64 at-risk women identified through Fox Chase Risk Assessment Programs and the NCI Clinical Cancer Genetics Program (CCGP) at the National Naval Medical Center (NNMC).
- A process evaluation analysis will assess participants' experiences using TACHD.
- Being tested
- Web-Based Decision Support
- Keywords
- Web-Based Decision Support, Breast Cancer Risk
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Decision SupportBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Conduct a formative evaluation of the impact of the chemoprevention module of the Trusted Advisor for Cancer Health Decisions (TACHD) decision support intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study start18 May 2009
- Primary completion26 May 2010
- Study completion26 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for High Risk for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906321
- Sponsor's protocol ID
- 999909150
- Other IDs
- 09-C-N150
- Status last verified
- 26 May 2010
- First submitted
- 20 May 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Guttmacher AE, Collins FS. Genomic medicine--a primer. N Engl J Med. 2002 Nov 7;347(19):1512-20. doi: 10.1056/NEJMra012240. No abstract available.
PubMed 12421895Collins FS. Shattuck lecture--medical and societal consequences of the Human Genome Project. N Engl J Med. 1999 Jul 1;341(1):28-37. doi: 10.1056/NEJM199907013410106. No abstract available.
PubMed 10387940Rose AL, Peters N, Shea JA, Armstrong K. Attitudes and misconceptions about predictive genetic testing for cancer risk. Community Genet. 2005;8(3):145-51. doi: 10.1159/000086757.
PubMed 16113531
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Web-Based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT00906321
- Acronym / sponsor ID
- 999909150
- Keywords
- Web-Based Decision Support, Breast Cancer Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 May 2009
- Primary completion
- 26 May 2010 (actual)
- Study completion
- 26 May 2010 (actual)
- First posted
- 21 May 2009 (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.
Background:
- Chemoprevention is the use of preventive medications to reduce the risk of breast cancer for women who are at a high risk of developing the disease. Although the treatment has shown effectiveness in preventing cancer development, chemoprevention is notably underutilized even by women who are at a high risk of developing breast cancer.
- Researchers are interested in determining if better decision support mechanisms, such as interactive Web sites, can help to overcome some of the barriers to chemoprevention.
Objectives:
- To develop and test a prototype Web-based module that will provide decision support to women who are considering chemoprevention for breast cancer.
Eligibility:
- Women 35 years of age and older who are at high risk for breast cancer and whose doctor has recommended chemoprevention (either Tamoxifen or Raloxifene), and who have no other history of cancer (apart from non-melanoma skin cancer or precancerous cervical lesions).
- Participants must have a working e-mail address and access to a computer with internet access and a telephone.
Design:
- Participants who are considering chemoprevention will be randomized to a Web-based decision support module or standard care online information resources.
- Participation lasts two months and involves using the online resources provided and filling out questionnaires two times during the study (at the beginning and the end).
The first time will be at the begin of the study.
- No medical treatments are offered as a part of this study
Detailed description
BACKGROUND:
- Breast cancer chemoprevention has been notably underutilized.
- Barriers to integrating breast cancer risk reducing measures include: lack of time, low priority of risk reduction in comparison to treatment, the need to personalize risks and benefits of chemoprevention, and the need for resources/information necessary for women to make informed decisions.
- Access to quality decision support resources to facilitate making informed, preference-sensitive decisions about chemoprevention may provide a mechanism to overcome some of the current barriers to chemoprevention utilization.
OBJECTIVES:
- Develop and refine a web-based patient decision support module for high-risk women making a decision about breast cancer chemoprevention.
- Conduct a randomized study of TACHD decision support versus standard care online information support to evaluate the impact of the chemoprevention module of the TACHD decision support intervention.
ELIGIBILITY:
- Women with no history of cancer other than cervical carcinoma in situ or non-melanoma skin cancer
- High risk for breast cancer based on at least one of the following:
- Gail score > 1.67
- History of atypical hyperplasia (either ductal or lobular)
- History of lobular carcinoma in situ
- Documentation of a deleterious BRCA1 or BRCA2 mutation
- Considering a decision about chemoprevention with tamoxifen or raloxifene
- Access to an IBM-compatible or MacIntosh personal computer with broadband Internet access
- Access to an email account
- Access to a telephone
- Aged 35 or older
- Able to communicate in English verbally and in writing
DESIGN:
- The project will be guided by the Cognitive-Social Health Information Processing (CSHIP) model overall, and incorporate the Ottawa Decision Support. Framework (ODSF) in one consistent decision support process.
- Testing of the chemoprevention decision support module will be conducted in a two-group pre- post-test experimental design with 64 at-risk women identified through Fox Chase Risk Assessment Programs and the NCI Clinical Cancer Genetics Program (CCGP) at the National Naval Medical Center (NNMC).
- A process evaluation analysis will assess participants' experiences using TACHD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Concurrent participation in another cancer chemoprevention study
- Prior history of cancer, other than cervical carcinoma in situ or non-melanoma skin cancer
- Ever taken tamoxifen or raloxifene
- Age less than 35
- Unable to communicate in English verbally and in writing
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 |
|---|---|---|
| Web-Based Decision Support | Behavioural | – |
Primary outcome
Conduct a formative evaluation of the impact of the chemoprevention module of the Trusted Advisor for Cancer Health Decisions (TACHD) decision support intervention
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 2 Jul 2017.
- Background: PubMed 12421895Guttmacher AE, Collins FS. Genomic medicine--a primer. N Engl J Med. 2002 Nov 7;347(19):1512-20. doi: 10.1056/NEJMra012240. No abstract available.
- Background: PubMed 10387940Collins FS. Shattuck lecture--medical and societal consequences of the Human Genome Project. N Engl J Med. 1999 Jul 1;341(1):28-37. doi: 10.1056/NEJM199907013410106. No abstract available.
- Background: PubMed 16113531Rose AL, Peters N, Shea JA, Armstrong K. Attitudes and misconceptions about predictive genetic testing for cancer risk. Community Genet. 2005;8(3):145-51. doi: 10.1159/000086757.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Decision Support in people with High Risk for Breast Cancer and Risk Reduction Behavior, run by National Cancer Institute (NCI) 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 0 inclusion and 8 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 2 Jul 2017. 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?
Conduct a formative evaluation of the impact of the chemoprevention module of the Trusted Advisor for Cancer Health Decisions (TACHD) decision support intervention. 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 NCT00906321, which also lists 3 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 2 Jul 2017.