title: A cluster randomized, controlled trial of breast and cervix cancer screening in Mumbai, India: methodology and interim results after three rounds of screening.
abstract: Cervix and Breast cancers are the most common cancers among women worldwide and extract a large toll in developing countries. In May 1998, supported by a grant from the NCI (US), the Tata Memorial Hospital, Mumbai, India, started a cluster-randomized, controlled, screening-trial for cervix and breast cancer using trained primary health workers to provide health-education, visual-inspection of cervix (with 4% acetic acid-VIA) and clinical breast examination (CBE) in the screening arm, and only health education in the control arm. Four rounds of screening at 2-year intervals will be followed by 8 years of monitoring for incidence and mortality from cervix and breast cancers. The methodology and interim results after three rounds of screening are presented here. Good randomization was achieved between the screening (n = 75360) and control arms (n = 76178). In the screening arm we see: High screening participation rates; Low attrition; Good compliance to diagnostic confirmation; Significant downstaging; Excellent treatment completion rate; Improving case fatality ratios. The ever-screened and never-screened participants in the screening arm show significant differences with reference to the variables religion, language, age, education, occupation, income and health-seeking behavior for gynecological and breast-related complaints. During the same period, in the control arm we see excellent participation rate for health education; Low attrition and a good number of symptomatic referrals for both cervix and breast.
authors.affiliation: Tata Memorial Hospital, Mumbai, India.
authors.forename: Indraneel
authors.initials: I
authors.lastname: Mittra
authors.forename: Gauravi A
authors.initials: GA
authors.lastname: Mishra
authors.forename: Shalini
authors.initials: S
authors.lastname: Singh
authors.forename: Sangeeta
authors.initials: S
authors.lastname: Aranke
authors.forename: Perin
authors.initials: P
authors.lastname: Notani
authors.forename: Rajendra
authors.initials: R
authors.lastname: Badwe
authors.forename: Anthony B
authors.initials: AB
authors.lastname: Miller
authors.forename: Elkan E
authors.initials: EE
authors.lastname: Daniel
authors.forename: Subhadra
authors.initials: S
authors.lastname: Gupta
authors.forename: Pallavi
authors.initials: P
authors.lastname: Uplap
authors.forename: Meenakshi H
authors.initials: MH
authors.lastname: Thakur
authors.forename: Subhash
authors.initials: S
authors.lastname: Ramani
authors.forename: Rajendra
authors.initials: R
authors.lastname: Kerkar
authors.forename: Balasubramanian
authors.initials: B
authors.lastname: Ganesh
authors.forename: Surendra S
authors.initials: SS
authors.lastname: Shastri
mesh_terms: D000328:Adult; D000367:Age Factors; D001943:Breast Neoplasms / Q000453:epidemiology* / Q000401:mortality; D016000:Cluster Analysis; D004522:Educational Status; D005260:Female; D014943:Global Health; D015438:Health Behavior; D006306:Health Surveys; D006801:Humans; D007182:Income; D007194:India / Q000453:epidemiology; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009790:Occupations; D011897:Random Allocation; D012042:Registries; D012947:Social Work; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology* / Q000401:mortality