| CTRI Number |
CTRI/2020/01/022614 [Registered on: 06/01/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The Study aims to find out how well the females in the slum areas know about Breast Self-Examination and also whether they perform Breast Self-Examination or not |
|
Scientific Title of Study
|
A Study on the Knowledge and Practices about Breast Self-Examination among women in slums of Mumbai. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shikha Panchal |
| Designation |
Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Health Policy, Prasanna School of Public Health,
Manipal Academy of Higher Education
Same as address 1
Udupi
KARNATAKA
576104
India |
| Phone |
9820901025 |
| Fax |
- |
| Email |
drshikhapanchal1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar Sumit |
| Designation |
Assistant Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Health Policy, Prasanna School of Public Health,
Manipal Academy of Higher Education
Same as address 1
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
- |
| Email |
sumitsharma315@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shikha Panchal |
| Designation |
Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Health Policy, Prasanna School of Public Health,
Manipal Academy of Higher Education
Same as address 1
Udupi
KARNATAKA
576104
India |
| Phone |
9820901025 |
| Fax |
- |
| Email |
drshikhapanchal1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Individual- Dr Shikha Panchal
Address- Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education. |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [] |
|
|
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 Shikha Panchal |
Slums of Ghatkopar,Mumbai(Community based Study) |
Prasanna School of Public Health, Manipal
Udupi
KARNATAKA |
9820901025
-
drshikhapanchal1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women suffering from Breast cancer will not be included in the study. |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women between the age group of 20 to 60 years living in slums of Mumbai and willing to voluntarily give consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Women with breast cancer in the same age group and not a resident of slum. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The results of the study will help to understand the prevalence of knowledge and practice of Breast self-examination in poor resource setting as well as the factors associated with the same. |
January to May 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It aims to increase awareness regarding the importance of practicing Breast Self-Examination |
January to May 2020 |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
Final Enrollment numbers achieved (Total)= "260"
Final Enrollment numbers achieved (India)="260" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2020 |
| Date of Study Completion (India) |
26/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Breast is the leading cause of cancer in Mumbai with relative proportion of 28.8% cases. It has been identified that vast majority of the females in the developing countries are unaware of performing regular Breast self-Examination. Breast Self-Examination is essential for early diagnosis of Breast cancer in slum areas as women living in slums suffer from poor health and unavailability of health services. It is the most cost-effective procedure which involves women looking and palpating each breast for lump, swelling, distortions and tenderness. It helps to increase awareness about risk factors and symptoms of Breast cancer and improve self care among women. Methodology: - Based on geographical distribution, Mumbai is divided into 6 zones. Each zone consists of 3 to 6 wards. 6th zone was randomly selected from these zones. 6th zone consists of 3 wards namely N, S, and T. Ward N was further randomly selected. It consists of 9 slums. Each of these 9 slums of ward N will be included in the study. These slums were considered as blocks and named as N1 to N9.
- PPS sampling technique will be adapted to select the number of households from each block. Households will be further selected randomly. From each household, one eligible participant will be selected using Kish grid method.
- A cross sectional study will be carried out among the women of age group 20 to 60 years. Before starting the interview, details of the study will be explained to them and informed consent will be taken.
- Interview will be based on the set of predetermined questionnaire. Confidentiality will be maintained throughout the study.
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