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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00416975
First received: December 27, 2006
Last updated: April 23, 2013
Last verified: April 2013

December 27, 2006
April 23, 2013
May 2000
December 2005   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00416975 on ClinicalTrials.gov Archive Site
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Individualized Risk-Based Education in Promoting Breast Cancer Screening in Healthy Women
Breast Cancer Risk-Tailored Messages for More Women

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Breast Cancer
  • 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.
Breast Cancer Risk Assessment Screening
Counseling Intervention and Eduation Intervention
Interventions:
  • Other: counseling intervention
  • Other: educational intervention
  • Procedure: evaluation of cancer risk factors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
899
February 2013
December 2005   (final data collection date for primary outcome measure)

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
Female
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00416975
MCC-00036, P30CA016059, MCC-00036
No
Virginia Commonwealth University
Virginia Commonwealth University
National Cancer Institute (NCI)
Principal Investigator: Joann N. Bodurtha, MD, MPH Massey Cancer Center
Virginia Commonwealth University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP