| CTRI Number |
CTRI/2022/01/039820 [Registered on: 28/01/2022] Trial Registered Prospectively |
| Last Modified On: |
21/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
KNOWLEDGE,ATTITUDE AND PRACTICE ABOUT RISK FACTORS,SYMPTOMS AND PREVENTION OF CERVICAL CANCER AMONGST WOMEN |
|
Scientific Title of Study
|
knowledge,attitude and practice about cervical cancer prevention |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MADHU SHREE R G |
| Designation |
POST GRADUATE |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI,110002
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI,110002
New Delhi
DELHI
110002
India |
| Phone |
07829825793 |
| Fax |
|
| Email |
madhu13mbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GAURI GANDHI |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI,110002
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI,110002
New Delhi
DELHI
110002
India |
| Phone |
7829825793 |
| Fax |
|
| Email |
ggandhi2004@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
MADHU SHREE R G |
| Designation |
POST GRADUATE |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI,110002
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI,110002
New Delhi
DELHI
110002
India |
| Phone |
07829825793 |
| Fax |
|
| Email |
madhu13mbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGYMAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI,110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Madhu shree R G |
MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,MAULANA AZAD MEDICAL COLLEGE,LOK NAYAK HOSPITAL,NEW DELHI,110002
New Delhi
DELHI |
07829825793
madhu13mbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee,Maulana Azad Medical College,Lok Nayak Hospital,new delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1)Patients not Diagnosed to have cervical cancer,CIN
2)Not a treated case of cervical cancer
3)not having family members who has cervical cancer |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
women aged between 20 years to 65 years |
|
| ExclusionCriteria |
| Details |
diagnosed cases of cervical cancer,CIN
treated cases of cervical cancer
women having any family member who has cervical cancer |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Proportion of women
1)who have knowledge about risk factors and symptoms of cervical cancer
2)who have knowledge regarding screening for cervical cancer
3)who have undergone screening for cervical cancer
4)who are willing to participate in primary and secondary preventive strategies |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of women who have knowledge and practices about cervical cancer prevention with regard to socioeconomic status of participants |
1 year |
|
|
Target Sample Size
|
Total Sample Size="379"
Sample Size from India="379"
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)
|
30/01/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical cancer is the second most common cancer among women worldwide. Increased incidence of this cancer is due to lack of awareness, negative attitude and poor practice. So the most effective method of cervical cancer prevention is by educating people about screening test and vaccination.Hence, aim of the study is to assess the knowledge, attitude and practice about risk factors, symptoms and prevention of cervical cancer among women in tertiary care center. This will be a hospital-based cross-sectional study which will be conducted among women attending Lok Nayak Hospital, New Delhi, India.Study period will be one year. Women between 20 and 65 year will be included. Diagnosed cases of cancer cervix/CIN,Treated case of cancer cervix and Women having any family member who has cervical cancer will be excluded. Informed written consent will be taken. A predesigned and validated self-administered questionnaire will be used to assess the knowledge regarding symptoms, risk factors, screening methods and vaccination against cervical cancer. Attitude towards cervical cancer patients and screening tests will be assessed. The questionnaire will be developed in English and Hindi understandable by the participants. The sufficient time will be given to answer the questions and the results will be analysed. |