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

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: evaluation of cancer risk factors

Other: educational intervention

Other: counseling intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00416975

P30CA016059 (U.S. NIH Grant/Contract)

MCC-00036 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

899 patients

Sex

Female

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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: