| 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
|
|
|
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
|
|
|
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. |