| CTRI Number |
CTRI/2018/06/014470 [Registered on: 08/06/2018] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Known the awareness level about breast cancer in students and working women |
|
Scientific Title of Study
|
Assessment of awareness level about breast cancer in students and working women inmates of hostel-A cross sectional study (community based) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VASANTHA S |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8675059800 |
| Fax |
|
| Email |
vasanthasks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G J CHRISTIAN |
| Designation |
Associated professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S VASANTHA |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8675059800 |
| Fax |
|
| Email |
vasanthasks@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss Pandithar Hospital, National Institute of Siddha,
Tambaram, Sanatorium,
chennai 47 |
| 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 S Vasantha |
womens hostels |
Inmates of student and working womens hostels,Tambaram,Chennai 47
Chennai
TAMIL NADU |
8675059800
vasanthasks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Inmates of students and working womens hostel |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Inmates of Students and Womens Hostel
Without any serious illness |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Knowing about the prevailing awarness about breast cancer.
Education the early detection of breast cancer so as to provide higher long time survival rates. |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/06/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It is a non randomized, Cross sectional sectional, Observational study.To study assess the Awareness level about Breast Cancer among the inmate of students and working womens. Total sample size 200. The study was conducted at students and working womens hostel chennai 47. Outcome of study was assessed on basis of health care questionnaire. The study concludes that only 17% of the inmates
were actually doing brest self examination, though 67% of them had an idea
about it. Mammary glands are
playing an important role in defining special function of female body one
should have a brief idea of what is normal for breast. Breast self examination
is a technique that helps you get familiar with the size, shape, and texture of
your breast. So for the raise of breast cancer awareness
in the female, there is a great need of effective BSE awareness educational
programs for early detection of breast cancer |