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

NCT00416975 | Completed

• 2 other identifiers: MCC-00036P30CA016059
• Study Type: interventional
• Target: 899
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Breast Cancer Risk Assessment Screening

OTHER

Counseling Intervention and Eduation Intervention

Other: counseling intervention; Other: educational intervention; Procedure: evaluation of cancer risk factors

Interventions

counseling intervention OTHER

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

educational intervention OTHER

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

evaluation of cancer risk factors PROCEDURE

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

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Counseling; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services

Study Officials

• Joann N. Bodurtha, MD, MPH

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: May 1, 2000
• Primary Completion: December 1, 2005
• Study Completion: February 1, 2013
• Last Updated: April 24, 2013

Record last verified: 2013-04