| CTRI Number |
CTRI/2024/06/069110 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Effect of health education on breast and cervical cancer awareness among women: An intervention study |
|
Scientific Title of Study
|
Effect of health education on breast and cervical cancer awareness among women in East Delhi: Pre-post intervention study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Sankhla |
| Designation |
First Year Post Graduate Student |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi |
| Address |
Department of Community Medicine, 4th floor, college building , University College of Medical Sciences and Guru Teg Bahadur Hospital, 2, Tahirpur road, GTB Enclave, Dilshad garden, New Delhi, 110095
North East
DELHI
110095
India |
| Phone |
8826171862 |
| Fax |
|
| Email |
sakshi.sankhla.6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragti Chhabra |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi |
| Address |
Department of Community Medicine, 4th floor, college building , University College of Medical Sciences and Guru Teg Bahadur Hospital, 2, Tahirpur road, GTB Enclave, Dilshad garden, New Delhi, 110095
North East
DELHI
110095
India |
| Phone |
9811687966 |
| Fax |
|
| Email |
pragschhabra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragti Chhabra |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi |
| Address |
Department of Community Medicine, 4th floor, college building , University College of Medical Sciences and Guru Teg Bahadur Hospital, 2, Tahirpur road, GTB Enclave, Dilshad garden, New Delhi, 110095
North East
DELHI
110095
India |
| Phone |
9811687966 |
| Fax |
|
| Email |
pragschhabra@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Sakshi Sankhla |
| Address |
Department of Community Medicine, 4th floor, college building , University College of Medical Sciences and Guru Teg Bahadur Hospital, 2, Tahirpur road, GTB Enclave, Dilshad garden, New Delhi, 110095 |
| 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 |
| Dr Sakshi Sankhla |
Anganwadi centre, Tahirpur |
AWC, Tahirpur Sarai and Tahirpur Village, Tahirpur road, New Delhi -110095
North East
DELHI |
8826171862
sakshi.sankhla.6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research (IEC-HR) University College of Medical Sciences, University of Delhi, Delhi- 110095 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health education intervention on breast and cervical cancer awareness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health education intervention on breast and cervical cancer awareness |
One session of health education intervention on breast and cervical cancer awareness will be given to women aged between 30 to 65 years. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women residents in the age group 30-65 years, who have been residing in the study area for at
least 6 months, not planning to shift for at least the duration of the study. |
|
| ExclusionCriteria |
| Details |
Women who are known, diagnosed or treated cases of breast or cervical cancer. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The proportion of women aware about any symptom of breast cancer at pre and post intervention.
2.The proportion of women aware about any symptom of cervical cancer at pre and post intervention. |
6 to 8.5 months from the date of recruitment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The proportion of women willing to undergo screening of breast and cervical cancer. |
6 to 8.5 months from the date of recruitment. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "77"
Final Enrollment numbers achieved (India)="77" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
20/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
SUMMARY OF PROTOCOL STUDY TITLE: EFFECT OF HEALTH EDUCATION ON BREAST AND CERVICAL CANCER AWARENESS AMONG WOMEN IN EAST DELHI: PRE-POST INTERVENTION STUDY. RATIONALE:
Cancer is a major cause of mortality globally, presenting an increasingly significant challenge to global health. Breast and cervical cancer are emerging as the leading cancers among women in India. Despite the potential for effective treatment with early diagnosis, awareness among Indian women is lacking, leading to delayed detection. Health education is key to improving awareness and promoting early screening. Despite the critical need, studies on health education interventions targeting breast and cervical cancer awareness and screening practices in India remain scarce, particularly within the context of Delhi. Therefore, the present study aims to fill this research gap by assessing the impact of a health education intervention on awareness of breast and cervical cancer among women. AIM:
To assess the effect of a health education intervention on awareness about breast and cervical cancer among women. PRIMARY OBJECTIVE:
To assess the effect of a health education intervention on awareness and knowledge about breast and cervical cancer among women in East Delhi. SECONDARY OBJECTIVE:
To assess the effect of a health education intervention on screening uptake for breast and cervical cancer among the women in East Delhi. STUDY SETTING:
The study shall be conducted in Tahirpur which consists of Tahirpur Village and Tahirpur Sarai, Delhi. Tahirpur is the field practice area for the Department of Community Medicine, UCMS & GTB Hospital, Delhi. STUDY DESIGN:
A community-based, pre-post intervention study. STUDY DURATION:
April 2024 to August 2025. STUDY PARTICIPANTS:
Women aged between 30-65 years residing in Tahirpur, Delhi. SAMPLE SIZE:
A total of 70 women will be recruited for the study. METHODOLOGY:
A pre-post intervention study will be conducted among women selected using a two-stage systematic random sampling method. They will be interviewed using a self-prepared, semi-structured, pre-tested questionnaire. A health education-based intervention developed to educate women in groups will be implemented. After three months of health education, an end-line survey will be conducted using the same questionnaire to assess the effect of the intervention. STUDY TOOL:
1. A self-prepared, semi-structured, pre-tested, interviewer administered questionnaire will be used which has been adapted from the Breast Module of the Cancer Awareness Measure (Breast-CAM) and the Cervical Cancer Awareness Measure (Cervical CAM). The questionnaire comprises sections on socio-demographic data, warning signs, risk factors, knowledge, and screening behavior for both breast and cervical cancer. 2. The educational materials regarding the signs, symptoms, risk factors, and screening methods for breast and cervical cancer sourced from the module for the Multipurpose Workers (MPWs)- Female/Male on Prevention, Screening and Control of common Non-Communicable Diseases will be utilized. PRIMARY OUTCOME MEASURES:
The proportion of women aware about any symptom of: 1. Breast cancer at pre and post intervention. 2. Cervical cancer at pre and post intervention. SECONDARY OUTCOME MEASURES:
The proportion of women willing to undergo screening of breast and cervical cancer. STATISTICAL ANALYSIS:
The data collected will be entered into MS Excel spreadsheet and it will be analyzed using IBM-SPSS software V20.0. Findings of the study will be described in terms of proportions for categorical variables and mean, median and standard deviation and inter-quartile range, respectively for continuous variables. Appropriate statistical tests of significance like McNemar’s test will be used to test the significance of the change in proportion. The p-value of less than 0.05 will be considered statistically significant. |