Early Detection of Breast Cancer and Cervical Cancer in Women in India
Conditions
Breast Cancer - Cervical Cancer
Conditions: official terms
Breast Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
breast cancer, cervical cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Primary Purpose: Screening
Intervention
Name: active surveillance Type: Other
Name: educational intervention Type: Other
Name: examination Type: Procedure
Name: long-term screening Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 64 Years
Minimum Age: 35 Years
Gender: Female
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
Location
Tata Memorial Hospital
Mumbai, India
Status: Recruiting
Contact: Surendra S. Shastri, MD - 91-22-2415-4379
Start Date
May 1998
Sponsors
Tata Memorial Hospital
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page