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

NCT ID: NCT00020098

Last Updated: 2012-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2001-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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evaluation of cancer risk factors

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role lead

Principal Investigators

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Paula Glauber, RN

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

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National Naval Medical Center

Bethesda, Maryland, United States

Site Status

Medicine Branch

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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00-C-0039

Identifier Type: -

Identifier Source: secondary_id

MB-NAVY-B99-088

Identifier Type: -

Identifier Source: secondary_id

CDR0000067716

Identifier Type: -

Identifier Source: secondary_id

000039

Identifier Type: -

Identifier Source: org_study_id

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