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CTRI Number  CTRI/2018/06/014554 [Registered on: 18/06/2018] Trial Registered Prospectively
Last Modified On: 14/06/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational study nested in intervention trial 
Study Design  Other 
Public Title of Study   Assessment of cancer awareness 
Scientific Title of Study   Comparative Evaluation of Cancer Awareness Among Project Participants and Similar General Female population in Mumbai, India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R A Badwe 
Designation  Professor of Surgical Oncology and Director, Tata Memorial Centre, Mumbai  
Affiliation  Tata Memorial Centre 
Address  Director Office, Main Building, Tata Memorial Hospital, Dr E Borges Road,Parel.

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000   
Fax    
Email  badwera@tmc.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gauravi Mishra 
Designation  Professor and Physician 
Affiliation  Tata Memorial Centre 
Address  Room No. 314, Department of Preventive Oncology, 3rd floor, Service Block Building, Tata Memorial Hospital, Dr E Borges Road,Parel.

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000   
Fax    
Email  gauravi2005@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gauravi Mishra 
Designation  Professor and Physician 
Affiliation  Tata Memorial Centre 
Address  Room No. 314, Department of Preventive Oncology, 3rd floor, Service Block Building, Tata Memorial Hospital, Dr E Borges Road,Parel.

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000   
Fax    
Email  gauravi2005@yahoo.co.in  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr E Borges Road,Parel, Mumbai, India. Mumbai MAHARASHTRA 
Type of Sponsor  Research institution and hospital 
 
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 R A Badwe  Tata Memorial Hospital  Room No. 314, Department of Preventive Oncology, 3rd floor, Service Block Building,Tata Memorial Hospital, Dr E Borges Road,Parel,India.
Mumbai
MAHARASHTRA 
91-22-24177000

badwera@tmc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ,Tata Memorial Hospital,Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  For Arm 1 and Arm 2 – all alive women who were participants of earlier trial. For Arm 3 – similar age matched general female population residing in the nearby selected slums  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  85.00 Year(s)
Gender  Female 
Details  For Arm 1 and Arm 2 – all alive women who were participants of the selected cluster of the Intervention Arm and from the Control Arm respectively, of the earlier cluster randomized trial. For Arm 3 – similar age matched general female population residing in the nearby selected slum cluster and belonging to similar socio-economically disadvantaged population of Mumbai 
 
ExclusionCriteria 
Details  Arm 1 & Arm 2: All women who were not a part of the earlier trial will be
excluded.
Arm 3: All women who are included in Arm 1 and Arm 2 will be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The long term retention of cancer awareness education among the trial participants will be assessed.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
a) We will evaluate the long-term retention of cancer awareness education among the trial participants enrolled in the screening arm (received cancer awareness education up to four times) as compared to participants enrolled in the control arm (received cancer awareness education only once).   12 months  
b) We will investigate the prevalence of cancer awareness in socio-economically and age – wise similar general female population, who are not a part of the trial.
 
12 months  
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
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)   20/06/2018 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Cancers of cervix and breast account for 50% of cancers and 42% of all deaths respectively from cancers among women in India. A research project entitled "Early Detection of Common Cancers in Women in India" was set up in 1998 by the Tata Memorial Hospital to investigate the efficacy of simple low cost tests such as Visual Inspection of the cervix with Acetic Acid (VIA) for the early detection of cervical cancers and Clinical Breast Examination (CBE) for the early detection of breast cancers. In this project around 75,000 women were enrolled in the Screening Arm. These women were invited for health education on cancer awareness and screening for breast and cervical cancers four times at an interval of two years. The last time they received health education was around a decade back. Another group of approximately 76,000 women were enrolled in the Control Arm of the trial. These women were invited for one single round of cancer related health education at the time of enrollment, which was nearly 15 years ago. The current sub-study is planned according to the instructions from the present External Data Safety Monitoring Committee (DSMC) after their review of the study in March 2016 and March 2017. It was advised by the DSMC to conduct a companion nested case control study to the main trial to evaluate the long-term retention of the given cancer awareness education.

The Primary Objectives of the trial are to evaluate the long term retention of cancer awareness education among the trial participants.

Methodology: Study Area: Twenty slum-clusters of Mumbai, which were already selected by simple random sampling and randomized into 10 Screening-Clusters and 10 Control-Clusters, from the ongoing study and one nearby slum cluster with similar socio – economic background, which was not included in the prior intervention.

Study Population:

1) Arm 1: Randomly selected participants from one of the randomly selected clusters of the screening arm, from among the 10 screening clusters of the ongoing study

2) Arm 2: Randomly selected participants from one of the randomly selected clusters of the control arm, from among the 10 control clusters of the ongoing study

3) Arm 3: Socio-economically and age wise similar women from one new cluster which is randomly selected from the three slum clusters in Mumbai (wherein women have not been exposed to such cancer awareness programme before).

The women will be enrolled in the study only after obtaining the informed consent . Personal interviews using a pre-designed questionnaire will be conducted for each of these enrolled women to evaluate the retention of health education among participants in Arm 1 and Arm 2. The women from Arm 3 will also be interviewed using the same questionnaire to assess their knowledge regarding various aspects of cancer. The questionnaire will mainly cover the risk factors, signs and symptoms, methods of early detection, prevention and basic modality of management of breast, cervical and oral cavity cancers, since these topics were covered in the health education delivered in the main study.

Sample size: Around 400 randomly selected participants from each arm will be listed.

Benefits:

a) The information gained by conducting personal interviews will help us understand the duration and content retention of health education about common cancers in women when delivered once and when delivered up to four times, as compared to the similar general population of women who have never been exposed to structured, organized cancer related health education. b) The results of this study would be beneficial to guide the public health professionals and policy makers to understand better the modality, frequency and impact of community based health education.





 
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