Individualized Risk-Based Education in Promoting Breast Cancer Screening in Healthy Women

Tracking Information
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; (submitted: February 23, 2010)	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.
Detailed Description	OBJECTIVES: Primary; Compare the impact of risk-tailored messages vs standard health information on the outcome of mammography in healthy women. Secondary; Compare the effect of these interventions on breast self-examination, clinical breast exam, risk perceptions, and breast cancer worry.; Compare the mechanism of action of these interventions on participants by assessing the impact of covariants (coping mechanisms, expanded Health Belief Model variables, breast cancer worry, breast cancer risk factors including family history, risk perceptions, discussion of breast cancer with relatives, previous screening practices, intentions to screen, and various demographic variables—age, race, and education) on breast cancer screening. 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.; Arm I (intervention group): Participants undergo a computerized risk assessment followed by personalized risk-tailored health messages. Health messages are based on principles of the expanded Health Belief Model (HBM). These messages include screening and lifestyle recommendations, information on the seriousness of breast cancer, instructions on how to arrange a mammography appointment, and contact information for genetic and psychosocial counseling.; Arm II (control group): Participants receive generalized breast health information sheets that contain appropriate screening and lifestyle recommendations for the general public and contact information for genetic and psychosocial counseling. 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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Screening
Condition ICMJE	Breast Cancer
Intervention ICMJE	Other: counseling intervention Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.; Other: educational intervention Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.; Procedure: evaluation of cancer risk factors Women in the intervention group will be offered breast cancer risk assessment at baseline. Computerized risk assessment is followed by personalized risk tailored health messages. The health messages will also include appropriate recommendations for genetic and psychosocial counseling. Baseline measurements from a questionnaire given prior to the intervention will capture current breast cancer screening practices (mammography, clinical breast exam and self exam), intentions to get mammograms, family discussion of breast cancer, risk perceptions, and breast cancer worry. Important demographic variables and breast cancer risk factors will also be measured. Participants will receive follow up telephone interviews at 1, 6, and 18 months to assess mammography use.
Study Arms	Breast Cancer Risk Assessment Screening; Counseling Intervention and Eduation Intervention; Interventions: Other: counseling intervention; Other: educational intervention; Procedure: evaluation of cancer risk factors
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 23, 2010)	899
Original Enrollment ICMJE; (submitted: December 27, 2006)	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: Receiving care at the Women's Health Center gynecology clinic in downtown Richmond, VA or at either the satellite Stony Point or Hayes Willis clinics; No history of breast cancer, including in situ lesions; At least 7 years old at first menarche; No prior genetic counseling or genetic testing for breast cancer; Hormone receptor status not specified PATIENT CHARACTERISTICS: Female; Menopausal status not specified; Not pregnant PRIOR CONCURRENT THERAPY: Not specified
Sex/Gender	Sexes Eligible for Study: Female
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 )
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	Principal Investigator: Joann N. Bodurtha, MD, MPH Massey Cancer Center
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