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Individualized Risk-Based Education in Promoting Breast Cancer Screening in Healthy Women
This study is ongoing, but not recruiting participants.
First Received: December 27, 2006   Last Updated: March 7, 2009   History of Changes
Sponsors and Collaborators: Massey Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00416975
  Purpose

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.


Condition Intervention
Breast Cancer
Other: counseling intervention
Other: educational intervention
Procedure: evaluation of cancer risk factors

Study Type: Interventional
Study Design: Screening, Randomized
Official Title: Breast Cancer Risk-Tailored Messages for More Women

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 900
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416975

Sponsors and Collaborators
Massey Cancer Center
Investigators
Principal Investigator: Joann N. Bodurtha, MD, MPH Massey Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000463954, MCV-36
Study First Received: December 27, 2006
Last Updated: March 7, 2009
ClinicalTrials.gov Identifier: NCT00416975     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Healthy
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009