| CTRI Number |
CTRI/2024/06/069446 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Health Education] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Increasing clinical breast examination through health education interventions in rural Maharashtra |
|
Scientific Title of Study
|
Pragmatic Stepped Wedge Cluster Randomization Trial to evaluate the screening of clinical breast examination through health education interventions in rural Maharashtra |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shahina Begum |
| Designation |
Scientist E |
| Affiliation |
ICMR-NIRRCH, Mumbai |
| Address |
Room No 27, Dept. of Biostatistics, ICMR-NIRRCH, JM Street Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9122-24192040 |
| Fax |
|
| Email |
begums@nirrch.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shahina Begum |
| Designation |
Scientist E |
| Affiliation |
ICMR NIRRCH |
| Address |
Room No 27 Dept. of Biostatistics, ICMR-NIRRCH, JM Street Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224192041 |
| Fax |
|
| Email |
begums@nirrch.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Shahina Begum |
| Designation |
Scientist E |
| Affiliation |
ICMR NIRRCH |
| Address |
Room No 27 Dept of Biostatistics, IMCR-NIRRCH, JM Street Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224192041 |
| Fax |
|
| Email |
begums@nirrch.res.in |
|
|
Source of Monetary or Material Support
|
| Department of Health Research
2nd Floor, IRCS Building,
1, Red Cross Road,
New Delhi - 110001.
Website:www.dhr.gov.in |
|
|
Primary Sponsor
|
| Name |
Department of Health Research |
| Address |
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - 110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Shahina Begum |
Primary Health Centre Narayngaon Junner |
Room No NA PHC Narayngaon Junner Pune
Pune
MAHARASHTRA |
912224192040
begums@nirrh.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR-NIRRCH ETHICS COMMITTEE FOR HUMAN STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
women aged 30-55 years neither diagnosed with breast cancer not Pregnant or lactating |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education and Capacity building of HCWs |
Breast cancer: Knowledge of signs, symptoms, risk factor, Clinical Breast examination
The total intervention period 18 months. |
| Comparator Agent |
Standard Breast cancer awareness |
Standard Breast cancer awareness through government health programme when intervention not reached |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women between 30-55 years of age will be included in the study |
|
| ExclusionCriteria |
| Details |
Women who have already diagnosed with breast cancer and are under treatment, pregnant women and lactating women will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent Increase in breast cancer awareness breast cancer awareness |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in Self Breast examination & clinical breast examination practices |
3 years |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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 3 |
|
Date of First Enrollment (India)
|
07/07/2024 |
| 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="3"
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 aim of this study is to form a sustainable,
community-based outreach program using ASHA to promote breast cancer (BC) awareness
program and trained ANM/LHV, and mid-level care providers to conduct Clinical
Breast examination at primary health care along with creating a good referral
system. The cross sectional study design will be adopted and interventions will
be given. A total of 500 women aged 30-55 years will be selected to assess the
impact of intervention on changes in knowledge and the utilization of BC
services over the specified time period. The study will also try to find out
the delay in treatment seeking and quality of life of the women diagnosed with
BC. The study will be conducted in Junnar block of Pune district. The outcomes
of the study will be increased in awareness, & Clinical Breast Examination,
reduction in individual and system level delay in treatment seeking and
sustainability of program at lower level of health system. |