| CTRI Number |
CTRI/2018/04/013518 [Registered on: 27/04/2018] Trial Registered Prospectively |
| Last Modified On: |
18/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the current knowledge,attitude and perception of women towards screening mammography with valid questionnaire |
|
Scientific Title of Study
|
Development and validation of a tool to assess the knowledge,attitude and perception of women towards screening mammography |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Chandrasekhar |
| Designation |
Post Graduate |
| Affiliation |
School Of Allied Health sciences,Manipal Academy Of Higher Education,Manipal |
| Address |
Department of Medical Imaging Technology,School of Allied Health Science,Manipal Academy of Health Education,Manipal,udupi,
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8247251983 |
| Fax |
|
| Email |
priyankachandrasekhar96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Winniecia Dkhar |
| Designation |
Assistant Professor |
| Affiliation |
School Of Allied Health sciences,Manipal Academy Of Higher Education,Manipal |
| Address |
Department of Medical Imaging Technology,School of Allied Health Science,Manipal Academy of Health Education,Manipal,udupi,
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8095372184 |
| Fax |
|
| Email |
winniecia.dkhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Suresh Sukumar |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
School Of Allied Health sciences,Manipal Academy Of Higher Education,Manipal |
| Address |
Department of Medical Imaging Technology,School of Allied Health Science,Manipal Academy of Health Education,Manipal,udupi,
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9886118811 |
| Fax |
|
| Email |
suresh.medicalimaging@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [RESEARCH INSTITUTION] |
|
|
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 |
| Priyanka Chandrasekhar |
Manipal Academy Of Higher Education |
Room No:38,Department of Medical Imaging Technology,School of Allied sciences,Manipal Academy Of Higher Education,Madhav Nagar,Manipal.
Udupi
KARNATAKA |
8247251983
priyankachandrasekhar96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Hospital,Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No specific conditions |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
General population |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will develop standardized instrument to assess the knowledge,awareness and perception towards screening mammography. |
13 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We will develop standardized instrument to assess the knowledge,awareness and perception towards screening mammography. |
13 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/04/2018 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Breast cancer is the most common cancer in females worldwide. Lack of knowledge and negative attitude towards screening practices contribute to delayed diagnosis of early stage cancer. There is lack of standardized instrument to assess the woman knowledge, awareness of Mammography. This study is intended to develop and validate a tool to assess the knowledge, attitude and perception of screening mammography. Phase I of the study is a qualitative research, where in, 15 individuals are until theoretical saturation has reached, questionnaire will be constructed. In phase II four subjects in the field of medical imaging and mammography will validate the items generated from phase I. In phase III exploratory factor analysis will be used to measure the relationship between the variables. There by developing a standardized instrument to assess the knowledge, awareness and perception towards screening mammography. |