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

Study Overview
=================
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.

Official Title
-----------------
Breast Cancer Risk-Tailored Messages for More Women

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: counseling intervention
* Other: educational intervention
* Procedure: evaluation of cancer risk factors


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Breast Cancer Risk Assessment Screening<br>Counseling Intervention and Eduation Intervention | Other: counseling intervention<br>* 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.<br>Other: educational intervention<br>* 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.<br>Procedure: evaluation of cancer risk factors<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To reduce the impact of breast cancer by promoting screening, increasing breast health awareness, and providing supportive resources to women who want them; |  | 12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer