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CTRI Number  CTRI/2019/04/018748 [Registered on: 24/04/2019] Trial Registered Prospectively
Last Modified On: 26/08/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Collaborative Action for cancer control among Mumbai Police. 
Scientific Title of Study   Collaborative Action for Control of Cancer and Other Non-Communicable Diseases among Mumbai Police 
Trial Acronym  CACC 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gauravi Ashish Mishra 
Designation  Professor and Physician 
Affiliation  Tata Memorial Hospital 
Address  Room No.314, 3rd Floor, Department of Preventive Oncology, Service Block Building, Tata Memorial Hospital, Parel, Mumbai-400012
Room No.306, 3rd Floor, Department of Preventive Oncology, Service Block Building, Tata Memorial Hospital, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India 
Phone  2224177000   
Fax    
Email  gauravi2005@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gauravi Ashish Mishra 
Designation  Professor and Physician 
Affiliation  Tata Memorial Hospital 
Address  Room No.314, 3rd Floor, Department of Preventive Oncology, Service Block Building, Tata Memorial Hospital, Parel, Mumbai-400012
Room No.306, 3rd Floor, Department of Preventive Oncology, Service Block Building, Tata Memorial Hospital, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India 
Phone  2224177000   
Fax    
Email  gauravi2005@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gauravi Ashish Mishra 
Designation  Professor and Physician 
Affiliation  Tata Memorial Hospital 
Address  Room No.314, 3rd Floor, Department of Preventive Oncology, Service Block Building, Tata Memorial Hospital, Parel, Mumbai-400012
Room No.306, 3rd Floor, Department of Preventive Oncology, Service Block Building, Tata Memorial Hospital, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India 
Phone  2224177000   
Fax    
Email  gauravi2005@yahoo.co.in  
 
Source of Monetary or Material Support  
Tata Trusts, World Trade Centre, Cuffe Parade, Mumbai. 
 
Primary Sponsor  
Name  Tata Trusts 
Address  World Trade Centre-1, 26th floor, Cuffe Parade, Mumbai-400005 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gauravi Mishra  Tata Memorial Hospital  Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 
2224177000

gauravi2005@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TMH IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  For Oral, Diabetes and Hypertension screening, all Mumbai Police personnel and their adult family members are eligible to participate (irrespective of age). For Breast and cervix examination all female police personnel and female family members between 30-65 years are eligible to participate. For respiratory screening all traffic police. 
 
ExclusionCriteria 
Details  Any acute or chronic health condition that may limit the ability of the potential participant to participate in the study.
For screening for Obstructive Airway Disease the exclusion criteria is active pulmonary tuberculosis/any active infectious disease and any subject unable to perform spirometry
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To formulate a demonstrable and sustainable model on prevention, control and early detection of NCDs including common cancers among the Police personnel and their families in Mumbai, that can be replicated in other parts of India.  24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Compliance to health education programmes among the police personnel and their family members regarding prevention and early detection of common cancers and NCDs and the factors affecting the same.  24 months 
Compliance to screening of NCDs and common cancers among the police personnel and their family members and the factors affecting the same.  24 months 
Prevalence of common cancers viz. Breast, Uterine Cervix and Oral Cavity Cancers and pre-cancers of Uterine Cervix and Oral Cavity among Police personnel and their family members.  24 Months 
Prevalence of Diabetes, Hypertension and Obesity among Police personnel and their family members and prevalence of Obstructive Airways Diseases among the traffic Police.   24 Months 
Prevalence of risk factor exposure to NCDs including common cancers among the Mumbai Police and their families.  24 months 
 
Target Sample Size   Total Sample Size="70000"
Sample Size from India="70000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/06/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
No Publications  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The Mumbai Police, a workforce of around 35,000, strive to enforce the law of the land, in order to create a fear free environment and make Mumbai a safer and better place to live. However, many researchers have established that this group that protects us, are themselves at high risk of all Non Communicable Diseases (NCDs) including cancers.  The Police service has been identified as a stressful occupation because of long working hours, irregular dietary habits, irregular sleep patterns, lack of regular exercise and addiction to tobacco and alcohol predisposing them to several health risks.

We propose to undertake a research project to formulate a demonstration model on prevention, control and early detection of NCDs viz obesity, diabetes, hypertension for all, COPDs and Small Airway Diseases specifically for traffic Police and common cancers (oral cavity, breast, cervical) among the Police personnel and their families in Mumbai, that can be replicated in other parts of India. Capacity building of the existing Police Medical and health teams is ingrained within the project, so that the entire program becomes sustainable when the research project is complete.

Anticipated benefits: Around 70,000 people which includes 35,000 Police and 35,000 family members (expecting atleast one family member to participate) will be directly benefitted with health awareness, screening of NCDs and common cancers and de-addiction services. The actual benefit will be several folds higher, as this programme will create healthy Police families. This programme will also promote the advancement of Research Team within the Tata Trusts.

Background work undertaken till date: Several meetings have been held with the Police Commissioner and the Deputy Commissioner of Police of various zones ensuring their support for this program. Awareness sessions have been initiated at several Police Stations and some Police and their family members have started approaching the Department of Preventive Oncology, TMH for cancer screening.

A pilot camp was conducted at Matunga to understand the feasibility of the programme. 186 police personnel and their 19 family members participated in this camp. The prevalence of tobacco and alcohol addiction was much higher as compared to the population figures. Nearly 70% were obese, 22% were hypertensives and 17% diabetics. Many were detected with this health condition for the first time in the camp. Forty one police personnel were diagnosed with oral pre-cancers and one was diagnosed with invasive oral carcinoma. All these police were totally unaware about their oral lesions. The findings of this pilot camp re-inforce the fact that the prevalence of NCDs and cancers is very high among police personnel. Awareness on risk factors and their prevention, combined with screening for NCDs and cancers needs to be implemented urgently for all police personnel.

The entire proposal involves covering the entire Mumbai Police and their families with health awareness, cancer and NCD screening and de-addiction services over a period of 24 months. We want to build up a demonstrable and sustainable model to improve health of Police workforce in Mumbai that can be replicated all over the country.

 
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