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CTRI Number  CTRI/2025/02/080920 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 22/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   A collaborative project of Tata Memorial Hospital and Brihanmumbai Municipal Corporation to develop a sustainable model for implementation of the NP-NCD 
Scientific Title of Study   Collaborating with Local Public Health Services in Mumbai for Formulating a Sustainable Model for Implementation of NP-NCD (National Programme for Prevention of Non-Communicable Diseases) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gauravi Mishra 
Designation  Professor and Physician H 
Affiliation  Tata Memorial Hospital 
Address  3rd Floor Department of Preventive Oncology Tata Memorial Hospital, Parel, Mumbai - 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224174634  
Fax    
Email  gauravi2005@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Gauravi Mishra 
Designation  Professor and Physician H 
Affiliation  Tata Memorial Hospital 
Address  3rd Floor Department of Preventive Oncology Tata Memorial Hospital, Parel, Mumbai - 400012


MAHARASHTRA
400012
India 
Phone  02224174634  
Fax    
Email  gauravi2005@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Gauravi Mishra 
Designation  Professor and Physician H 
Affiliation  Tata Memorial Hospital 
Address  3rd Floor Department of Preventive Oncology Tata Memorial Hospital, Parel, Mumbai - 400012


MAHARASHTRA
400012
India 
Phone  02224174634  
Fax    
Email  gauravi2005@yahoo.co.in  
 
Source of Monetary or Material Support
Modification(s)  
Brihanmumbai Municipal Corporation, Mahapalika Marg, Fort, Mumbai - 400001 
Tata Memorial Hospital, Department of Preventive Oncology, Service Block, Dr E Borges Road, Parel, Mumbai 400012 
 
Primary Sponsor
Modification(s)  
Name  Tata Memorial Centre 
Address  Dr E Borges Marg, Mumbai 400012 
Type of Sponsor  Other [Grant-in Aid Institute of the Department of Atomic Energy, Government of India] 
 
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  Brihanmumbai Municipal Corporation  Mahapalika Marg, Fort, Mumbai - 400001
Mumbai
MAHARASHTRA 		 02224174634

gauravi2005@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee-2  Approved 
Not Applicable  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Capacity building for awareness common cancers.  Phase -1: Training and Capacity Building Establishing cancer awareness and screening clinics in Health posts/ Maternity homes in 25 wards of BMC and theoretical and hands on training for ANMs/ ASHAs/ ASHA coordinators/ CHVs 
Intervention  Screening and Training for Screening   Phase 2: Screening for Oral Cavity Cancers- All grassroot level BMC health staff, other BMC Staff and general population willing to undergo screening for oral cavity cancers will be included. Screening for Breast and Cervical Cancers- All women BMC grassroot level health staff, other BMC women staff and women from general population between the age group 30 – 65 years willing to undergo screening for breast and cervical cancers will be enrolled. Theoretical and Practical Hands on Training for Common Cancer Screening- ANMs and other identified health staff by Senior BMC Health Authorities will be invited to participate in theoretical as well as practical hands on training in the cancer awareness and screening clinics that will be set up at Health Posts and some Maternity Homes. 
Intervention  Sensitization, Establishment of TCCs and Capacity building for Tobacco Control and Cessation  Phase-3: Capacity building of Medical and Paramedical staff for Tobacco Cessation and Control and setting up of Tobacco Cessation Clinics in Collaboration with BMC in each Ward 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Inclusion criteria as per different components for Phase-I, Phase-II and Phase III
Phase-I:
All ANMs/ ANM Co-coordinators, CHVs, ASHAs (including BMC, NUHM and NCD corner) and MPWs working currently under BMC health set up and willing to participate in training for creating cancer awareness will be enrolled.
Phase-II:
Screening for Oral Cavity Cancers
All grassroot level BMC health staff, other BMC Staff and general population willing to undergo screening for oral cavity cancers will be included.
Screening for Breast and Cervical Cancers:
All women BMC grassroot level health staff, other BMC women staff and women from general population between the age group 30 – 65 years willing to undergo screening for breast and cervical cancers will be enrolled.
Theoretical and Practical Hands on Training for Common Cancer Screening:
ANMs and other identified health staff by Senior BMC Health Authorities will be invited to participate in theoretical as well as practical hands on training in the cancer awareness and screening clinics that will be set up at Health Posts and some Maternity Homes. 
 
ExclusionCriteria 
Details  Any acute or chronic health condition that may limit the ability of the potential participant to participate in screening will not be enrolled.
Any grassroot level BMC health staff or other health staff not willing for training and capacity building programme will not be enrolled.

For breast and cervical screening component of Phase 2 of the study, all women who are less than 30 years and more than 65 years of age and all men will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To formulate a sustainable and demonstrable model that aims at seamless integration and support of a tertiary cancer care hospital along with the existing public health system in Mumbai.  6 years 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To build capacity to create awareness among 4600 grassroot level health staff like ANM /Co-ordinators, CHVs, ASHAs (including BMC, NUHM and NCD corner), MPWs (working currently under BMC health set up) regarding prevention and early detection of common cancers through a structured training programme.
2. To determine the prevalence of common cancers among BMC grassroot level health staff by conducting screening of common cancers Viz, Breast, Uterine Cervix and Oral Cavity cancers using low cost and effective technologies.
3. To build capacity through theoretical and practical hands on training among BMC grassroot level health staff to screen for common cancers. 		 6 years 2 months 
 
Target Sample Size   Total Sample Size="5000"
Sample Size from India="5000" 
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)   25/02/2025 
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="6"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

National Cancer Control Programme was launched in India since 1975 with prevention, creating awareness, early detection and appropriate treatment of common cancers as its major objective. National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) was launched in 2010 and has been renamed as National programme for prevention and control of non-communicable diseases (NP-NCD) since 2023 with an aim to create awareness and conduct population based screening (PBS) for individuals 30 years and above for five common Non-Communicable Diseases (NCD) i.e., Hypertension, Diabetes and Cancers of the Oral Cavity, Uterine Cervix and Breast. NCD Cells have been established at District level. Although the screening for hypertension and diabetes has been initiated at some places, there have been minimal initiatives with respect to common cancer screening with only less than 1.2% of country. population been screened for common cancers so far. And a lack of training of the existing public health services staff in undertaking cancer awareness and screening is one of the most important reasons for this poor coverage.

The department of Preventive Oncology at the Tata Memorial Hospital has vast experience of capacity building of various cadres of staff in awareness and screening of common cancers and also for implementing population-based awareness and screening programmes. BMC health set up forms the basis of public health system in Mumbai. It has dispensaries, health posts, maternity homes, tertiary care general hospitals and Medical Colleges with very good network of nearly 5000 grass root level staff spread over 25 BMC wards. The health department of BMC is keen on initiating common cancer awareness and screening at population level, however there is a need for formal training on conducting standardized common cancer awareness programme and in conducting screening for common cancers among grass root level staff deployed under BMC. With regards to implementation of cancer awareness and screening programme in Mumbai, the best possible way could be collaboration between Tertiary Cancer Hospital in Mumbai Tata Memorial Hospital and existing public health system i.e. Brihanmumbai Municipal Corporation (BMC). Hence, we propose to collaborate with BMC and act as resource partners for capacity building of their grass root level staff for awareness and screening of common cancers and for hand holding in establishing cancer awareness, screening and tobacco cessation clinics. 

Aim: To formulate a sustainable and demonstrable model that aims at seamless integration and support of a tertiary cancer care hospital along with the existing public health system in Mumbai.  

Primary Objective: Capacity building for awareness and screening of common cancers, among BMC grassroot level health staff, establishing cancer awareness and screening clinics, sensitization about hazards of tobacco and establishment of TCCs and capacity building for Tobacco Control and Cessation:

1.       To build capacity to create awareness among 4600 grassroot level health staff like ANM /Coordinators, CHVs, ASHAs (including BMC, NUHM and NCD corner), MPWs (working currently under BMC health set up) regarding prevention and early detection of common cancers through a structured training programme. 

2.       To determine the prevalence of common cancers among BMC grassroot level health staff by conducting screening of common cancers Viz, Breast, Uterine Cervix and Oral Cavity cancers using low cost and effective technologies.

3.       To build capacity through theoretical and practical hands on training among BMC grassroot level health staff to screen for common cancers.

4.       To determine the prevalence of common cancers among other BMC staff and general population from the community by conducting screening of common cancers Viz, Breast, Uterine Cervix and Oral Cavity Cancers using low cost Methodologies.

5.       To formulate the referral linkage of all screen positive cases for cancer screening to the Department of Preventive Oncology, Tata Memorial Hospital, Mumbai and other BMC hospitals for diagnostic confirmation and further management and identify the compliance for the same and the factors affecting it.

6.       To sensitize BMC staff about the harmful effects of using tobacco and importance of tobacco cessation.

7.       To establish TCCs in at-least 5 BMC wards and conduct capacity building of selected BMC Medical and Paramedical for Tobacco Control and Cessation counseling.

8.       To strengthen Institutional capacity of BMC in implementing in awareness and screening of common cancers.

We propose to implement the current project in three phase wise manner over a span of six years as mentioned below:

Phase 1: Capacity building for awareness common cancers (spread over 14 months)

All ANMs/ ANM Co-coordinators, CHVs, ASHAs (including BMC, NUHM and NCD corner) and MPWs working currently under BMC health set up and willing to participate in training for creating cancer awareness will be enrolled.

Phase 2: Screening and Training for Screening (spread over 36 months)

Screening for Oral Cavity Cancers: All grassroot level BMC health staff, other BMC Staff and general population willing to undergo screening for oral cavity cancers will be included.

Screening for Breast and Cervical Cancers: All women BMC grassroot level health staff, other BMC women staff and women from general population between the age group 30 – 65 years willing to undergo screening for breast and cervical cancers will be enrolled.

Theoretical and Practical Hands on Training for Common Cancer Screening:

ANMs and other identified health staff by Senior BMC Health Authorities will be invited to participate in theoretical as well as practical hands-on training in the cancer awareness and screening clinics that will be set up at Health Posts and some Maternity Homes.

Phase 3: Sensitization, Establishment of TCCs and Capacity building for Tobacco Control and Cessation (spread over 24 months)

All health care staff of NCDs and Tobacco Control cells who are willing to participate or staff nominated by BMC Health Department will be provided training on conducting tobacco cessation counseling (TCC). Tobacco Cessation Clinics (TCC) will be established in at-least 5 BMC health posts to act as a model that could be replicated in other health post.

This Implementation Research will supplement efforts of National programme for prevention of non-communicable diseases and also support implementation of National Tobacco Control Programme. This sustainable project will act as a demonstrable model that could be replicated across different municipal corporations in India.

 


 
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