Individualized Risk-Based Education in Promoting Breast Cancer Screening in Healthy Women
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ClinicalTrials.gov Identifier: NCT00416975 |
Recruitment Status
:
Completed
First Posted
: December 28, 2006
Last Update Posted
: April 24, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | December 27, 2006 | |||
First Posted Date ICMJE | December 28, 2006 | |||
Last Update Posted Date | April 24, 2013 | |||
Study Start Date ICMJE | May 2000 | |||
Actual Primary Completion Date | December 2005 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To reduce the impact of breast cancer by promoting screening, increasing breast health awareness, and providing supportive resources to women who want them; [ Time Frame: 12 years ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00416975 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Individualized Risk-Based Education in Promoting Breast Cancer Screening in Healthy Women | |||
Official Title ICMJE | Breast Cancer Risk-Tailored Messages for More Women | |||
Brief Summary | RATIONALE: Education, based on a patient's risk factors, may help promote breast cancer screening in healthy women. PURPOSE: This randomized clinical trial is studying individualized risk-based education to see how well it promotes breast cancer screening in healthy women compared to standard education. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized study. Participants are approached to complete a baseline survey while they are waiting for their clinic visits. Baseline surveys measure breast cancer risk factors, current breast cancer screening practices, intentions to screen, risk perceptions, breast cancer worry, coping mechanisms, and discussion of breast cancer with relatives. After completion of the baseline surveys, participants are then randomized to 1 of 2 education arms.
All participants undergo follow-up assessment by telephone (or by mail if unreachable by phone) at 1, 6, and 18 months after the initial intervention. Self-reported mammography use, additional breast health monitoring practices, risk perception, breast cancer worry, coping mechanisms, HBM-related beliefs, and family communication are measured. PROJECTED ACCRUAL: A total of 900 participants will be accrued for this study. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Screening |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms | Breast Cancer Risk Assessment Screening
Counseling Intervention and Eduation Intervention
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
899 | |||
Original Enrollment ICMJE |
900 | |||
Actual Study Completion Date | February 2013 | |||
Actual Primary Completion Date | December 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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Ages | 40 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00416975 | |||
Other Study ID Numbers ICMJE | MCC-00036 P30CA016059 ( U.S. NIH Grant/Contract ) MCC-00036 ( Other Identifier: Massey Cancer Center ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Virginia Commonwealth University | |||
Study Sponsor ICMJE | Virginia Commonwealth University | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | Virginia Commonwealth University | |||
Verification Date | April 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |