Early Detection of Common Cancers in Women in India

Phase 3

Completed

• Conditions: Breast and Cervix cancer in Indian women

• Registration Number: CTRI/2010/091/001205
• Lead Sponsor: Tata Memorial HospitalParel, Mumbai-400012,India

Brief Summary

The primary aim of this ongoing cluster randomized controlled trial, in urban slum women, aged 35-64 years, in Mumbai, India, is to investigate the efficacy of cancer education and screening, using affordable, sustainable and culturally acceptable techniques, i.e. Clinical Breast Examination (CBE) and Visual Inspection with 4% Acetic Acid (VIA), performed by trained female primary health workers (FPHWs) in the: 1) Early detection of breast and cervical cancer, 2) Downstaging of breast and cervical cancer, 3) Reduction in breast and cervical cancer mortality, 4) Reduction in cervical cancer incidence. The secondary aims of this trial are: 1) To estimate the cost and resource needs for conducting community-based cancer education and screening for breast and cervical cancers by CBE and VIA, 2) To study the behavioral, cultural and psychological factors affecting participation of women in such programs.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-05-24
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 151538

Inclusion Criteria

1. Women between the ages of 35 and 64 years, 2) Who were living in the selected araes for more than one year and, 3) Who had no previous history of cancer.

Exclusion Criteria

1. Women below 35 years and above 64 years.2) Women who were staying in the area for less than a year3) Women who had previous history of cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Estimation of the downstaging2)Mortality reduction3)Screening participation rates 4)Participation rates for cancer education programs in the control group 5)Compliance rates to diagnostic confirmation and treatment acceptance and completion6)Estimation of CBE and VIA positivity rates 7)Agreement rates between the FPHWs and expert physician for screening test performance	1)at the end of four rounds of screening2)after completion of the study 3)every 24 months4)at the end of first 24 months5)every 24 months6)every 24 months7)every 24 months

Secondary Outcome Measures

Name	Time	Method
1) Cost-effectiveness analysis2)Assessment of behavioral, cultural and psychological factors affecting participation of women in the trial

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr. Surendra S Shastri

Principal investigator

22-24154379

shastri@vsnl.com