Early Detection of Breast Cancer and Cervical Cancer in Women in India
Recruitment status was: Recruiting
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.
Other: active surveillance
Other: educational intervention
Procedure: long-term screening
|Study Design:||Allocation: Randomized
Primary Purpose: Screening
|Official Title:||Early Detection of Common Cancers in Women in India|
- 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 [ Designated as safety issue: Yes ]
|Study Start Date:||May 1998|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632047
|Tata Memorial Hospital|
|Mumbai, India, 400012|
|Principal Investigator:||Surendra S. Shastri, MD||Tata Memorial Hospital|