Early Detection of Breast Cancer and Cervical Cancer in Women in India

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

151538 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Brief Summary

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RATIONALE: Health education programs and screening methods, such as clinical breast examination and examination of the cervix, may help reduce the number of women who develop breast cancer and cervical cancer.

PURPOSE: This randomized clinical trial is studying the early detection of breast cancer and cervical cancer in women in India.

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Detailed Description

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OBJECTIVES:

* To investigate the effectiveness of well planned health education programs (HEP) and low-cost screening methods (e.g., clinical breast examination \[CBE\] and visual inspection of the cervix painted with 4% acetic acid \[VIA\]) in down-staging and reducing the incidence of and mortality due to breast and cervical cancer.

OUTLINE: Patients are randomized to 1 of 2 arms.

* Arm I (intervention): Participants undergo intervention comprising health education programs (HEP), clinical breast examination (CBE), and visual inspection of the cervix painted with 4% acetic acid (VIA) every 2 years for up to 8 years. Participants also undergo active surveillance over 8 years.
* Arm II (control): Participants receive one HEP. Participants also undergo active surveillance over 8 years.

Conditions

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Breast Cancer Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SCREENING

Interventions

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active surveillance

Intervention Type OTHER

educational intervention

Intervention Type OTHER

examination

Intervention Type PROCEDURE

long-term screening

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Resides in 1 of 20 geographically defined clusters within the slums of Mumbai, India

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Minimum Eligible Age

35 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No