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

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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening
Official Title:	Breast Cancer Risk-Tailored Messages for More Women

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

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 ]


Enrollment:	899
Study Start Date:	May 2000
Study Completion Date:	February 2013
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Breast Cancer Risk Assessment Screening Counseling Intervention and Eduation Intervention	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.

Arms

Assigned Interventions

Breast Cancer Risk Assessment Screening

Counseling Intervention and Eduation Intervention

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.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416975

Sponsors and Collaborators

Virginia Commonwealth University

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Joann N. Bodurtha, MD, MPH	Massey Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00416975 History of Changes
Other Study ID Numbers:	MCC-00036, P30CA016059, MCC-00036
Study First Received:	December 27, 2006
Last Updated:	April 23, 2013
Health Authority:	United States: Federal Government

Keywords provided by Virginia Commonwealth University:


breast cancer

Additional relevant MeSH terms:


Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases

ClinicalTrials.gov processed this record on February 27, 2015