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
|
|
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
|
|
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
|
|
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
|
|
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.
|