Complementary or Alternative Medicine Practices Used by Women at Increased Risk for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Use of Complementary or Alternative Medicine Practices by Women at Increased Risk for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020098
• Other study ID #: 000039
• Secondary ID: 00-C-0039MB-NAVY
• Status: Completed
• Phase: N/A
• First received: July 11, 2001
• Last updated: March 28, 2012
• Start date: June 2000
• Est. completion date: September 2001

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Increasing knowledge about the complementary or alternative medicine practices used by women who are at increased risk for breast cancer may provide useful information for planning breast-cancer-prevention strategies.

PURPOSE: Clinical trial to determine how many women who are at increased risk for breast cancer use complementary or alternative medicine.

Description:

OBJECTIVES: I. Determine the prevalence of complementary or alternative medicine (CAM) practices among adult women who are enrolled in the Risk Assessment Clinic at the National Naval Medical Center Breast Care Center and are found to be at increased risk for developing breast cancer. II. Correlate the use of CAM with individual risk for breast cancer. III. Define the types of CAM practices used by this study population. IV. Identify reasons why this study population is using CAM.

OUTLINE: Patients are stratified according to prevalence of complementary and alternative medicine practices (enteral/parenteral vs psychologic/neurologic). Patients complete a Personal Risk Assessment form, pre-test/post-test knowledge questionnaires, and a survey questionnaire.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study within approximately 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Enrolled in the Risk Assessment Clinic (RAC) of the National Naval Medical Center and found to be at increased risk for breast cancer based on at least one of the following: Estimated risk of at least 1.7% for developing breast cancer over the next 5 years, as determined by the Breast Cancer Risk Assessment Tool (BCRAT) Prior history of lobular carcinoma in situ or ductal carcinoma in situ Family history of breast or ovarian cancer consistent with autosomal dominant pattern of inheritance or empirically elevated risk of breast cancer based on a single first- or second-degree relative with breast or ovarian cancer Must have attended the RAC education session within past 3-6 months Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior cancer except ductal carcinoma in situ or basal cell carcinoma Able to read and understand English

PRIOR CONCURRENT THERAPY: Not specified

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• evaluation of cancer risk factors

Locations

Country	Name	City	State
United States	Medicine Branch	Bethesda	Maryland
United States	National Naval Medical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,