| CTRI Number |
CTRI/2025/04/085502 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of health education on knowledge regarding breast cancer and breast self-examination |
|
Scientific Title of Study
|
Effect of health education on knowledge regarding breast cancer and breast self-examination among women in an urban slum of Raipur: An interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suchita Mohanty |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR |
| Address |
Dr. Suchita Mohanty, Post Graduate Junior Resident, Room no 2111,2nd floor Department of Community and Family Medicine,Medical College building, All India Institute of Medical Sciences Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8895875205 |
| Fax |
|
| Email |
suchitamohanty328@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gouri Kumari Padhy |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR |
| Address |
Dr Gouri Kumari Padhy, Additional Professor Room no 2117, 2nd floor Department of Community and Family Medicine, Medical College Building AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881712 |
| Fax |
|
| Email |
gouripadhy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suchita Mohanty |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR |
| Address |
Dr Suchita Mohanty Post Graduate Junior Resident, Room no 2111, 2nd floor, Department of Community and Family Medicine, Medical College building, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8895875205 |
| Fax |
|
| Email |
suchitamohanty328@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
Dr Suchita Mohanty |
| Address |
Dr Suchita Mohanty, Post Graduate Junior Resident,Room no 2111, 2nd floor, Department of Community and Family Medicine, Medical College Building,
AIIMS Raipur
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Suchita Mohanty |
AIIMS Raipur |
Room no 2111, 2nd floor Department of Community and Family Medicine, Medical college building AIIMS Raipur
Raipur
CHHATTISGARH |
08895875205
suchitamohanty328@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Above 18 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health education |
Health education regarding breast cancer and breast self examination (Talk, display of images and Video)
30 MIN TO 1 HR SESSION
ON DIFFERENT DAYS FOR DIFFERENT AREAS.DATA COLLECTION WILL BE DONE AFTER 3 MONTHS OF INTERVENTION |
| Comparator Agent |
NO INTERVENTION |
NO INTERVENTION |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Age 19 -65 YEARS |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knowledge regarding breast cancer and breast self examination |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess determinants of knowledge regarding breast cancer and breast self examination |
3 months |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
28/11/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Breast cancer is the commonest cancer among women in developed and developing countries making it second only to lung cancer as the cause of cancer related deaths among women as it has poor prognosis on late detection and poor awareness is the cause of late detection. Objective of study is to assess the effect of health education on improvement of knowledge regarding breast cancer and breast self-examination among women residing in an urban slum of Raipur and to assess the determinants of knowledge regarding breast cancer and breast self-examination. This will be an interventional study. (With intervention in two streets and no intervention in other two street). Women residing in urban field practice area of AIIMS Raipur are taken as the study population. Women belonging to the age group of 18 to 65 years are included in study. Women not able to comprehend the instruction, pregnant and lactating women, women not able to contact after 3 visits are excluded from the study. The estimated sample size for my study is 104. Cluster randomized sampling will be used to select street and recruit study participants. Each ward has 7 to 8 streets, each street will be considered as one cluster. From each ward two streets/clusters will be selected randomly by lottery method. Randomization of streets will be done to intervention and control arm. Total 4 streets will be selected (two for intervention and two as control). From each street/cluster, 26 study participants will be recruited. Baseline data will be collected before imparting health education in intervention area, data will be collected again after 3 months from both the areas after health education. Total duration of study is 2 years (18 month after IEC approval). Predesigned pre- tested questionnaire will be used with three subparts. Part 1 consisting of sociodemographic information. Part 2 consists of knowledge on symptoms and risk factors of breast cancer and Part 3 consists of knowledge related to breast self-examination. Health education regarding breast cancer (symptoms and risk factor) and breast self-examination will be given by delivering a talk and showing images related to breast self-examination from NPNCD guidelines and videos from other authentic sources like WHO. Data will be analyzed by using appropriate statistical tools like percentages, proportions, measures of central tendency, measures of dispersion, standard error of mean and tests of significance by using SPSS version 21computer software etc. Chi square test, t test and paired t test will be used to assess the effect of intervention. Chi square test will be used to find out association between categorical data like (knowledge and various socio demographic factors). |