Complementary or Alternative Medicine Practices Used by W... | NCT00020098

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

NCT00020098

Sponsor

National Institutes of Health Clinical Center (CC)

Status

Completed

Last Update Posted

Mar 29, 2012Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

evaluation of cancer risk factors

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2000

Primary Completion Date

Not provided

Completion Date

Sep 2001Actual

First Submitted Date

Jul 11, 2001

First Submission Date that Met QC Criteria

Feb 26, 2004

First Posted Date

Feb 27, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2012

Last Update Posted Date

Mar 29, 2012Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
evaluation of cancer risk factors	Procedure

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Type	Description	Link
00-C-0039
MB-NAVY-B99-088
CDR0000067716

Facility	Status	City	State	ZIP	Country	Contacts
National Naval Medical Center		Bethesda	Maryland	20889-5000	United States
Medicine Branch

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases