- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00906321
Facilitating Web-based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
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.
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI), 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
-INCLUSION CRITERIA:
- 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
- Women of all races and ethnic groups are eligible for this study.
EXCLUSION CRITERIA:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Collins 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.
- Rose 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999909150
- 09-C-N150
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Risk Reduction Behavior
-
Seattle Children's HospitalTickit Health SolutionsCompletedRisk Reduction BehaviorUnited States
-
University of Colorado, DenverNational Institute of Mental Health (NIMH)Active, not recruitingRisk Reduction BehaviorUnited States
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)CompletedHealth Behavior | Risk Reduction BehaviorUnited States
-
University of Colorado, DenverSmith-Richardson FoundationCompletedRisk Reduction Behavior | Reproductive BehaviorUnited States
-
University of California, San FranciscoNational Institute on Drug Abuse (NIDA)Completed
-
Technical University of LisbonCompleted
-
Jose María Maya MejíaUnknown
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedRisk Behavior | Risk Reduction | Emotion RegulationUnited States
-
Karen HeimerUniversity of Minnesota; U.S. Department of Justice; Cedar Rapids Community School...CompletedRisk Reduction BehaviorUnited States
Clinical Trials on Web-Based Decision Support
-
Dartmouth-Hitchcock Medical CenterNational Cancer Institute (NCI)CompletedSchizophreniaUnited States
-
University of SaskatchewanSaskatchewan Health Research FoundationCompleted
-
Beth Israel Deaconess Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedChronic Kidney Disease | End-Stage Renal DiseaseUnited States
-
National Taiwan University HospitalRecruitingInfertility, Female | Female InfertilityTaiwan
-
Cardenal Herrera UniversityCompleted
-
VA Office of Research and DevelopmentUniversity of California, San Francisco; Kaiser PermanenteRecruitingContraception | Contraception Behavior | Reproductive Health | Prepregnancy HealthUnited States
-
Göteborg UniversityVastra Gotaland Region; Swedish Diabetes AssociationCompletedDiabetes Type 1 | Pregnancy | Early MotherhoodSweden
-
National Taipei University of Nursing and Health...RecruitingShared Decision Making | Vaginal Birth After CesareanTaiwan
-
Stanford UniversityNational Cancer Institute (NCI)Completed
-
Kessler FoundationRecruitingSpinal Cord Diseases | Spinal Cord InjuriesUnited States