We went to an educational field visit to Kandivali(a suburb of Mumbai) yesterday. The motive was to observe ongoing community based randomized control trials being carried out for early detection of cervical and breast cancer, by Tata Memorial Hospital(TMH) and funded by National Institue Of Health(USA), the period of study being 1998-2015. We were enlightened about the study by Dr Pallavi Uplap, the Medical Officer at the site.
The study design is a community based cluster randomized trial using low cost technology approach. It comprises of 1,50,000 women belonging to socio-economically disadvantged population from slums across various suburbs of mumbai. Ten clusters namingly Nehru Nagar, Kherwadi, Bhandup, Kanjurmarg, Amboli, Jogeshwari, Malad, Kandivali and Borivali, have been selected and each randomized into intervention and control arm.
The Primary Aims of this study are to investigate the efficacy of low cost technology approach in down staging cancers of the breast and cervix, therefore subsequently reducing the mortality due to breast and cervix cancers among women in India.
In addition to this following are the Secondary Aims :
1. To estimate the cost and resource needs for conducting community based health-education and screening programs for cervix and breast cancer, using the above methods in India.
2. To determine the behavioral, cultural and psychological factors that influence participation
in such programs, in India.
3. To determine if such programs can be integrated into routine public health care activities, in India.
The Eligibilty Criteria for inclusion of women in the study are :
1.Women between the ages of 35 to 64 years
2.Residing in the area for more than 1 year.
3.Not previously diagnosed with breast or cervical malignancy or any other form of malignancy.
Depending upon study and control group following are the interventions which are done during the course of study :
Study Group
1.Clinical breast examination and VIA by trained Primary Health Workers at 24 month intervals(4 screenings)
2.Referral of screening positives to TMH.
3.Active Surveillance 24 months intervals(4 cycles)
4.Treatment, follow up and monitoring of incidence and mortality.
Control Group
1.Health Education - Once
2.Active Surveillance 24 month intervals(7 cycles)
3.Treatment of self referrals and monitoring of incidence and mortality
Finally the resultant downstaging and reduction in mortality data are compared between the study and control group.
675 cases of malignancies have been diagnosed under this study from May,1998 to Nov,2008 with 411 cases of Ca Breast and 264 cases of Ca Cervix. Of these, 567 patients have completed there treatment.
