Clinical trial NCT00020098: Complementary or Alternative Medicine Practices Used by Women at Increased Risk for Breast Cancer
Official title: Use of Complementary or Alternative Medicine Practices by Women at Increased Risk for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-02-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Naval Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Medicine Branch
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Paula Glauber, RN
role: STUDY_CHAIR
References: