| CTRI Number |
CTRI/2025/12/098677 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Swasthya Sakhi App on Facilitators in Secondary Prevention of Breast Cancer among Adult Women |
|
Scientific Title of Study
|
Developing and Evaluating the effectiveness of the Swasthya Sakhi App on Facilitators in Secondary Prevention of Breast Cancer among Adult Women Residing in Northern India |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARUNGBAM SARJU DEVI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MM COLLEGE OF NURSING |
| Address |
MM College of Nursing, Medical Surgical Nursing Department, Mullana, Ambala
MM College of Nursing, Medical Surgical Nursing Department, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
07497884937 |
| Fax |
|
| Email |
sarjusarungbam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SARUNGBAM SARJU DEVI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MM COLLEGE OF NURSING |
| Address |
MM College of Nursing, Medical Surgical Nursing Department, Mullana, Ambala
MM College of Nursing, Medical Surgical Nursing Department, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
07497884937 |
| Fax |
|
| Email |
sarjusarungbam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SARUNGBAM SARJU DEVI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MM COLLEGE OF NURSING |
| Address |
MM college of nursing,Medical Surgical Nursing Department,Mullana,Ambala
MM College of Nursing, Medical Surgical Nursing Department, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
07497884937 |
| Fax |
|
| Email |
sarjusarungbam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
MM(Deemed to be University),Mullana,Ambala,Haryana,133207 |
| 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 |
| sarju |
Maharishi Markendeshwar Hospital, Mullana, Ambala |
Medical Oncology department, Surgical oncology, radio oncology department, Outpatient department
Ambala
HARYANA |
07497884937
sarjusarungbam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr B.K Agrawal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no intervention |
routine care |
| Intervention |
swasthya Sakhi App |
Swasthya Sakhi App is a bilingual and user-friendly mobile health app designed to enhance early diagnosis and treatment of breast cancer among women by providing accessible information on awareness related to the (risk factor, signs and symptoms, diagnostic evaluation, treatment modalities and prevention), Infographic video related to self-breast examination, and facilitating referrals to nearby oncologists to ensure timely care and treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria:
Participants will be adult women who meet the following criteria:
a)Able to read and write in both Hindi and English
b)Own a smartphone
c)Willing to provide informed consent and participate in the study
d)Available during the data collection period |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
a)Adult women diagnosed with a mental illness
b)Those who are not familiar with using a smartphone
c)Those who are unavailable during the data collection and intervention period |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevention and early diagnosis of breast cancer among adult women |
4 week and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
User Satisfaction:
Satisfaction and acceptability of the Swasthya Sakhi App regarding usability, clarity, and usefulness.
Socio-Demographic Association:
Relationship between facilitators of secondary prevention and socio-demographic variables (age, education, occupation, etc.) |
1 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/01/2026 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study aims to identify the facilitators that influence the secondary prevention of breast cancer among adult women residing in Northern India and to develop a mobile application named Swasthya Sakhi that focuses on promoting these facilitators to encourage early diagnosis and timely treatment of breast cancer The app will serve as an educational and motivational tool designed to enhance awareness to improve health seeking behaviors and to support women in adopting preventive practices that contribute to the early detection and management of breast cancer |