| CTRI Number |
CTRI/2026/01/100044 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani Preventive Other (Specify) [Teaching Module Intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Study on the impact of a teaching module on breast cancer awareness in female students |
|
Scientific Title of Study
|
Evaluation of effectiveness of teaching module intervention on breast cancer awareness among the female students: A randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hashmi Syeda Asra Jabeen Hashmi Syed Nisaar |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine Bengaluru |
| Address |
Dept. of Tahaffuzi Wa Samaji Tib National Institute Of Unani Medicine Kottigepaliya Magadi Main Road Bengaluru 560091 Dept. of Tahaffuzi Wa Samaji Tib National Institute Of Unani Medicine Kottigepaliya Magadi Main Road Bengaluru 560091 Bangalore KARNATAKA 560091 India |
| Phone |
7249095909 |
| Fax |
|
| Email |
hashmisyedaasra51095@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Professor Zarnigar |
| Designation |
Professor |
| Affiliation |
National Institute Of Unani Medicine Bengaluru |
| Address |
Dept. Of Tahaffuzi Wa Samaji Tib National Institute Of Unani Medicine, Kottigepaliya Magadi Main Road Bengaluru 560091
Bangalore KARNATAKA 560091 India |
| Phone |
7483244027 |
| Fax |
|
| Email |
kzarnigar15@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Hashmi Syeda Asra Jabeen Hashmi Syed Nisaar |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine Bengaluru |
| Address |
Dept. Of Tahaffuzi Wa Samaji Tib National Institute Of Unani Medicine, Kottigepaliya Magadi Main Road Bengaluru 560091 Dept. Of Tahaffuzi Wa Samaji Tib National Institute Of Unani Medicine, Kottigepaliya Magadi Main Road Bengaluru 560091 Bangalore KARNATAKA 560091 India |
| Phone |
7249095909 |
| Fax |
|
| Email |
hashmisyedaasra51095@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbas Khan college for women
Address: Hazrath Hameedshah Dargah Compound, OTC Road, Cubbonpet, Bangalore, Karnataka 560002
Al Ameen Arts Science And Commerce College
Adress: Hosur Main Road, Near Lalbagh Main Gate, Sudhama Nagar, Bangalore, Karnataka 560027 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine Bangalore |
| Address |
Dept.of Tahaffuzi Wa Samaji Tib National Institute of Unani Medicine Bengaluru 560091 Karnataka India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Hashmi Syeda Asra Jabeen Hashmi Syed Nisaar |
Abbas khan college for women and Al Ameen Arts Science and Commerce College |
Hazrath Hameedshah Dargah Compound, OTC road, Cubbonpet, Bangalore 560002 Karnataka
And Lalbagh Main Gate Road, Bangalore 560027, Karnataka Bangalore KARNATAKA |
7249095909
hashmisyedaasra51095@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-NIUM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy female students more than or equal to 18 years of age. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No teaching module lecture on the breast cancer awareness will be given, only pre and post test will be taken. |
Only pre and post test will be taken, on the first day of study (baseline) and after 6 weeks. |
| Intervention |
Teaching module on Breast cancer awareness |
Teaching lecture will be taken on breast cancer awareness in the form of power point presentation on the first day of study only for about 60 minutes, after pre test is taken. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Females more than or equal to 18 years of age.
2. Females who are willing to participate.
3. Available during both pre and post sessions. |
|
| ExclusionCriteria |
| Details |
1. Unwilling to give consent or withdraw at any point.
2. Medical and paramedical course students.
3. Those who have chronic psychological illness.
4. Students with cognitive impairment or learning disabilities.
5. Students who has previously undergone formal training during workshops on breast cancer awareness or breast self examination within the last six months. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed using validated breast cancer awareness questionnaire. |
Pre test (baseline test) will be taken prior to administration of teaching module intervention and after 6 weeks knowledge retention will be assessed by same questionnaire. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="310" Sample Size from India="310"
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)
|
01/04/2026 |
| 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
|
| The Breast cancer is rapidly increasing, especially among women of reproductive and premenopausal age group. Contributing factors include changing lifestyle patterns, delayed childbirth, sedentary habits, and obesity. It is a major public health problem in both developed and developing countries and a leading cause of morbidity and mortality among women. Worldwide, over 1.15 million cases of breast cancer are diagnosed every year. Currently, breast cancer is the most common cancer among women in India, having surpassed cervical cancer. According to Indian Council of Medical Research 2023, breast cancer accounts for approximately 27.7 percent of all female cancers in the country. It is associated with a mortality rate of 13.7 deaths per 1,00,000 women, and in the year 2022 alone, a total of 1,92,020 women in India died due to breast cancer. Despite its growing prevalence, awareness remains alarmingly low. Diagnosis at advanced stages of disease contributes to the high mortality rate among women due to breast cancer. Breast cancer is a preventable cancer if detected early enough. The early detection of breast cancer not only increases the chances of successful treatment but also improves chances of survival. Globally, breast self examination, clinical breast examination (CBE) and mammography are the recommended screening test for early detection of breast cancer. Clinical breast examination and mammography require hospital visit and specialized instrument or technical expertise. Studies reveal that nearly 81 percent of rural women could not name even a single symptom of breast cancer. Approximately 85.1 percent had never heard of Breast Self Examination and none practiced it monthly. This highlights the need for structured teaching modules to promote breast cancer awareness and encourage early detection behavior among women. The present study aims to evaluate the effectiveness of a structured educational intervention in improving breast cancer awareness among female college students, with the goal of reducing diagnostic delays and lowering mortality rates. | |