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

Phase 2
Conditions
Breast Cancer
Cervical Cancer
Registration Number
NCT00632047
Lead Sponsor
Tata Memorial Hospital
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
151538
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Effectiveness of well planned health education programs and low-cost screening methods (e.g., clinical breast exam and visual inspection of the cervix) in reducing the incidence of and mortality due to breast and cervical cancer
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tata Memorial Hospital

🇮🇳

Mumbai, India

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