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

Tata Memorial Hospital

Status and phase

Unknown

Phase 2

Conditions

Breast Cancer

Cervical Cancer

Treatments

Other: active surveillance

Other: educational intervention

Procedure: long-term screening

Procedure: examination

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00632047

TATA-1900215717A1

CDR0000586791

Details and patient eligibility

About

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.

Full 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.

Enrollment

151,538 estimated patients

Sex

Female

Ages

35 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: