| CTRI Number |
CTRI/2024/10/075503 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [HEALTH EDUCATION IN FORM OF A PLANNED TEACHING PROGRAMME ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness Of A Breast Cancer Education Programme Among Women In Rural Kozhikode |
|
Scientific Title of Study
|
Effectiveness Of a Planned Teaching Programme On Knowledge Attitude and Practices Regarding Breast Cancer Among Adult Women In The Rural Field Practice Area Of a Tertiary Care Centre In Kozhikode District: A 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 Rahana Raj |
| Designation |
PG Student,Malabar Medical College Hospital and Research Centre |
| Affiliation |
|
| Address |
Malabar Medical College Hospital and Research Centre,Ulliyeri,Modakallur,Kozhikode
Kozhikode
KERALA
673315
India |
| Phone |
8050904620 |
| Fax |
|
| Email |
drrehnaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Karir |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Community Medicine
Malabar Medical College Hospital and Research Centre,Ulliyeri,Modakallur,Kozhikode
Kozhikode
KERALA
673315
India |
| Phone |
8050904620 |
| Fax |
|
| Email |
drshilpa011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahana Raj |
| Designation |
PG Student,Malabar Medical College Hospital and Research Centre |
| Affiliation |
|
| Address |
Department of Community Medicine
Malabar Medical College Hospital and Research Centre,Ulliyeri,Modakallur,Kozhikode
Kozhikode
KERALA
673315
India |
| Phone |
8050904620 |
| Fax |
|
| Email |
drrehnaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rural Field Practice Area of Malabar Medical College Hospital And Research Centre |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Rahana Raj |
Malabar Medical College Hospital And Research Centre Ulliyeri Modakallur kozhikode |
Rural Field Practice Area -Moodadi Panchayat and Thikkodi Panchayat
Kozhikode
KERALA |
8050904620
drrehnaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Breast Cancer Awareness Before and After A Planned Teaching Programme Among Healthy Volunteers Above 18 Years Of Age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education in the form of Planned Teaching Programme |
Duration Of Planned Teaching Programme is 30-40 minutes |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1.Women of age group 18 years and above
2.Women willing to give consent
|
|
| ExclusionCriteria |
| Details |
1. Women diagnosed with breast cancer
2. Women who are unable to participate in the study due to physical or mental illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in awareness regarding breast cancer among study participants |
First Post test on the same day of intervention(Health Education)
Second Posttest is after 4 weeks of intervention( health education) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="275"
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)
|
11/11/2024 |
| 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
|
Breast cancer is the most common cancer among females in the world and in India .According to the Globocan 2022 report, there were estimated 2.26 million and 192,020 new cases globally and in India respectively. In Kerala, though the health indices are far advanced in comparison to other states in India ,the age adjusted cancer incidence among females is high. Women tend to ignore the minor symptoms and do not show up at the hospital until it is unbearable, owing to their household responsibilities. Low level of health literacy as well as poor health seeking behavior are some of the most important factors for this ignorance. Other reasons of ignorance are lack of self confidence in their ability to perform the breast self examination correctly, fear of possible discovery of a lump and embarrassment associated with manipulation of the breast. There are only a handful studies done among Kerala’s women population on their knowledge, attitude and practices regarding breast cancer and its prevention. No such educational intervention studies have been done in Kozhikode district on this topic. This study intends to assess their baseline knowledge, attitude and practices regarding breast cancer, as well as gauge the same after conducting a planned education session for them. Since knowledge is the best pill and best vaccine ,this study will test the effectiveness of our planned health education session in adult women, so that it can be used in the future for massive health literacy drives among them. |