Trial Information

Breast Cancer Risk-Tailored Messages for More Women

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.