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CTRI Number  CTRI/2024/07/071698 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of educational strategy on prevention of cervical cancer and to re-enforce the acceptance of various screening tests for cervical cancer among women. 
Scientific Title of Study   Development of Community-Based Multimodal Strategies in the prevention of cervical cancer and to re-enforce the acceptance of various screening tests for cervical cancer among women through an interventional approach. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Puspanjali Mohapatro 
Designation  Assistant Professor 
Affiliation  SUM NURSING COLLEGE, SOA, DEEMED TO BE UNIVERSITY 
Address  Dept. of Community Health Nursing, Faculty of Nursing, SUM NURSING COLLEGE, SHIKSHA O ANUSANDHAN, DEEMED TO BE UNIVERSITY, K-8, Ghatikia, Bhubaneswar, Odisha,

Khordha
ORISSA
751003
India 
Phone  09337733185  
Fax    
Email  puspanjalimohapatra@soa.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Puspanjali Mohapatro 
Designation  Assistant Professor 
Affiliation  SUM NURSING COLLEGE, SOA, DEEMED TO BE UNIVERSITY 
Address  Dept. of Community Health Nursing, Faculty of Nursing, SUM NURSING COLLEGE, SIKSHA O ANUSANDHAN, DEEMED TO BE UNIVERSITY, K-8, Ghatikia, Bhubaneswar, Odisha

Khordha
ORISSA
751003
India 
Phone  09337733185  
Fax    
Email  puspanjalimohapatra@soa.ac.in  
 
Details of Contact Person
Public Query  
Name  Puspanjali Mohapatro 
Designation  Assistant Professor 
Affiliation  SUM NURSING COLLEGE, SOA, DEEMED TO BE UNIVERSITY 
Address  Dept. of Community Health Nursing, Faculty of Nursing SHIKSHA O UNIVERSITY, SUM NURSING COLLEGE, K-8, Ghatikia, Bhubaneswar, Odisha

Khordha
ORISSA
751003
India 
Phone  09337733185  
Fax    
Email  puspanjalimohapatra@soa.ac.in  
 
Source of Monetary or Material Support  
No 
 
Primary Sponsor  
Name  Puspanjali Mohapatro 
Address  Puspanjali Mohapatro, Ph.D. scholar in Nursing sciences, Faculty of Nursing SOA, DTU University, SUM Nursing College, Dept. of Community Health Nursing, Ghatikia, K-8, Bhubaneswar, Odisha, 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Puspanjali Mohapatro  Sub center  Angarpada village, Block-Jatni, Khordha, Odisha, 752054
Khordha
ORISSA 		 09337733185

puspanjalimohapatra@soa.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Medical Sciences & SUM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cervical cancer screening and prevention 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Community-Based Multimodal Strategies (CBMS)  Group -1 (maximum 30 to 45 min) • Group discussion will provide complete information on the Anatomy and Physiology of the female reproductive system along with causes, symptoms, risk factors, and successful treatment, and procedures of various screening tests such as VIA or pap test of cervical cancer through audiovisual aids (Tab) at NCD clinic to each group individually. • And supply visual aids pamphlets on cervical cancer education materials in Odia language. • A review of the discussion point, receiving feedback from the participants regarding the discussed points through question and answer, and group discussion. Group-2 (maximum 30 to 45 mins per individual participant) • The researcher will provide individual counselling to each participant with Face-to-face family counselling (especially the husband) by showing flipcharts on cervical cancer education materials in Odia language. • And supply information pamphlets on cervical cancer education materials in the Odia language. • A review of the discussion point, receiving feedback from the participants regarding the discussed points through question and answer, and group discussion. Group-3 • The intervention will same as Group 1 with additional Telephonic counselling. • Telephonic counselling with a short description of the importance of screening, and the positive effect of cervical screening. • It will be done twice after 1-week interval of intervention. • The duration will be 15 minutes per individual participant. Group-4 • The intervention will same as Group 2 with additional Telephonic counselling. • Telephonic counselling with a short description of the importance of screening, and the positive effect of cervical screening. • It will be done twice after 1-week interval of intervention. • The duration will be 15 minutes per individual participant. 
Comparator Agent  Standard care only  Provide health information audio prepared by the researcher related to the prevention of cervical cancer and screening to participants through mass media communication “SOA RADIO” to the participants of control arms with the physical presence of the researcher and health provider of the community. (Standard care) 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  • Those women who will be willing to give consent will be recruited to participate in the study.
• Those will be able to read and understand the Odia language.
 
 
ExclusionCriteria 
Details  • Those will not be available during data collection.
• Those having a past history of cervical cancer.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome could be measured by the percentage increase in women undergoing cervical cancer screening tests (e.g., Pap smear, HPV testing, VIA) before and after the intervention.  At 2month,4month,6month,12 month 
 
Secondary Outcome  
Outcome  TimePoints 
1. Measure the increase in knowledge and awareness about cervical cancer and its prevention among the target population through pre- and post-intervention surveys.
2. Evaluate the acceptance and satisfaction levels of the different screening methods among women using questionnaires and feedback forms.
3. Assess changes in health-seeking behaviour, such as regular visits for cervical health check-ups, through follow-up surveys.
4. Identify and measure the reduction in barriers (e.g., cultural, financial, logistical) that women face in accessing cervical cancer screening services.
 		 At 2month,4month,6month,12 month 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   15/08/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This study aims to develop and implement community-based multimodal strategies to prevent cervical cancer and enhance the acceptance of various screening tests among women aged 25-65 in Khordha District. The research approach is divided into two phases: Phase- I employ a mixed-method approach, while Phase- II uses a quantitative research approach. The research design is a Randomized control trial (community trial) conducted in the rural community under Angarpada panchayat, Jatani Block of Khordha District, Odisha, India. The population includes all women aged 25-65 in the district, with the sample drawn from 5 villages using simple random sampling. The goal is to evaluate the effectiveness of the intervention in increasing screening rates and awareness.

 
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