Randomized controlled trial to evaluate breast cancer screening by clinical breast examination in Trivandrum District, Kerala, India

Study sites:	Thiruvananthapuram (formerly called Trivandrum), Kerala, India
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	K. Ramadas (PI), S. Thara, Beela Sarah Mathew, Elizabeth Abraham, Gigi Thomas, Jem Prabhakar, Paul Augustine, Ramani Wesley, R. Rejnish Kumar; Regional Cancer Centre (RCC), Thiruvananthapuram, Kerala, India
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Start date:	2006
Closure date:	Ongoing
Objectives:	To evaluate whether three rounds of triennial clinical breast examination (CBE) can reduce the incidence rate of advanced breast cancers and reduce the rate of mortality from breast cancer
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Study outcomes:	This community-based cluster randomized controlled trial involving 120 000 women evaluates the role of intervention packages consisting of breast awareness, health education, opportunities for early clinical diagnosis (i.e. CBE), and the provision of readily accessible diagnosis and treatment services for the early detection and improved outcome of breast cancer. The intervention trial is being conducted in 14 administrative regions (“panchayats”) in Thiruvananthapuram District, Kerala, India. Approximately 120 000 households and about 120 000 women aged 30–69 years in the two sub-districts were grouped into about 275 clusters based on wards; 133 clusters were randomized to the intervention group to receive CBE. The other 142 clusters were randomized to the control group to receive the existing usual health care and health education on early detection of breast cancer. We have already demonstrated significant downstaging of breast cancers through CBE screening. The 10-year follow-up of the cohorts revealed the high negative predictive value of CBE: the invasive breast cancer detection rate in the CBE-negative women was very low.
Publications:	Sankaranarayanan R., Ramadas K., Thara S., Muwonge R., Prabhakar J., Augustine P., Venugopal M., Anju G., Mathew B.S. Clinical breast examination: preliminary results from a cluster randomized controlled trial in India. J Natl Cancer Inst. 2011;103(19):1476-80. PMID: 21862730 Grosse Frie K., Ramadas K., Anju G.A., Mathew B., Muwonge R., Sauvaget C., Thara S., Sankaranarayanan R. Determinants of participation in a breast cancer screening trial in Trivandrum District, India. Asian Pac J Cancer Prev. 2013;14(12):7301-7. PMID: 24460292
Funding:	Intramural funds from IARC
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