| CTRI Number |
CTRI/2025/08/092672 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Implementation research study] |
| Study Design |
Other |
|
Public Title of Study
|
Improving common cancer Screening and Early Treatment in India |
|
Scientific Title of Study
|
Implementation Research to Enhance Screening, Early Diagnosis and Initiation of
Treatment for Oral, Breast and Cervical Cancer in Selected Districts of 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 |
Tanvir Kaur |
| Designation |
Scientist G |
| Affiliation |
ICMR hqrs |
| Address |
V. Ramalingaswami
Bhawan, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9818737437 |
| Fax |
|
| Email |
kaurtanvir.hq@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanvir Kaur |
| Designation |
Scientist G |
| Affiliation |
ICMR hqrs |
| Address |
V. Ramalingaswami
Bhawan, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9818737437 |
| Fax |
|
| Email |
kaurtanvir.hq@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Tanvir Kaur |
| Designation |
Scientist G |
| Affiliation |
ICMR hqrs |
| Address |
V. Ramalingaswami
Bhawan, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9818737437 |
| Fax |
|
| Email |
kaurtanvir.hq@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR), New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR), New Delhi |
| Address |
Indian Council of Medical Research, V. Ramalingaswami Bhawan,
Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soumya Swaroop Sahoo |
AIIMS Bathinda, Punjab |
Room no. A 414, 3rd Floor, Department of CFM, Mandi Dabwali Road,
Bathinda, Punjab, India
151001
Bathinda
PUNJAB |
8895658170
swaroop.drsoumya@gmail.com |
| Dr Pallavi Shukla |
AIIMS, Delhi |
Room no. 136, Department of Preventive Oncology, Dr BRA-IRCH, AIIMS,
New Delhi
South
DELHI |
7042811351
dr.pallavishukla@gmail.com |
| Dr MalligaJ S |
Cancer institute (WIA), Chennai, District Thiruvannamalai, Tamil Nadu |
First Floor, Department of Preventive Oncology, Cancer institute (WIA),
Chennai
Tiruvanamalai
TAMIL NADU |
9445263286
js.malliga@cancerinstitutewia.org |
| Dr M Vijayakumar |
Dakshina Kannada, Karnataka State |
7th Floor, Department of Surgical Oncology, Yenepoya Medical
College, Mangaluru
Yenepoya (Deemed to
be University),
Mangaluru
Dakshina Kannada
KARNATAKA |
9686696055
mvijayakumar@yenepoya.edu.in |
| Dr Shahina Begum |
ICMR-NIRRCH, Mumbai (Palghar Site) Maharashtra State |
First Floor, Department of Biostatistics, ICMR-NIRRCH,
Mumbai
Palghar
MAHARASHTRA |
9503956734
begums@nirrch.res.in |
| Dr Prasanta Kr Borah |
ICMR-RMRC, NE Region, Dibrugarh |
Division of Epidemiology & Nutrition, ICMR-RMRC, NE
Region, Dibrugarh
Dibrugarh
ASSAM |
8811991450
borahprasant71@gmail.com |
| Dr Amit Sachdeva |
IGMC Shimla Himachal Pradesh |
1st Floor, Department of Community Medicine, Dental College Building, IGMC Shimla
Shimla
HIMACHAL PRADESH |
7018547237
dramitsachdeva2410@gmail.com |
| Dr Ankita Kankaria |
Technical Unit - PGIMER, Chandigarh |
Room No. 127, Department of Community Medicine & School of Public Health, PGI Chandigarh, Sector-12, Chandigarh
Chandigarh
CHANDIGARH |
9646259076
kankariaankita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Cancer Institute (WIA) IEC-NABH Accredited |
Approved |
| ICMR-NIRRCH Ethics Committee for Human Studies |
Approved |
| IEC AIIMS, New Delhi |
Approved |
| IEC IGMC Shimla |
Approved |
| IEC, AIIMS Bathinda |
Approved |
| IEC, PGIMER |
Submittted/Under Review |
| IEC/IRB ICMR RMRCNE |
Approved |
| Yenepoya Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Men and women who meet the inclusion criteria |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C53||Malignant neoplasm of cervix uteri, (3) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Model X
(Stakeholder relationships,Health Promotion, Capacity Building Workshops, Monitoring and Evaluation) |
1. Stakeholder relationships: : Identification of stakeholders and cancer champions and
developing inter-relationships.
2. Health promotion: Customization of Health promotion material and activities to enhance awareness and engagement in the communities.
3. Capacity building
workshops: Workshops would be held for community healthcare
workers to enhance screening coverage
4. Monitoring and Evaluation: Supportive supervision for ensuring improvement in
coverage and quality of screening, early diagnosis and
treatment initiation through
infrastructure, trained manpower, functional referral and back referral system, data driven monitoring using NCD
portal |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Household Survey: Any man or woman aged 30 years or above.
2. Cancer care pathway: Diagnosed or on treatment cancer patients and their caregivers.
3. Qualitative Data: Healthcare providers engaged with the community under
NP-NCD (ASHA/USHA/ANM/CHO/MO/Specialist), program officers
engaged in NP-NCD, community representatives, NGOs, In-charges of
private facilities empaneled with Ayushman Bharat
4. Facility assessment: District hospital, Sub district Hospitals, Community
Health Centers, AAM/HWC/SC/PHC/MCW/Urban Dispensary
Note: No upper limit for household survey and No age criterion for qualitative data |
|
| ExclusionCriteria |
| Details |
1. People who did not give consent to participate in the study
2. Anyone with mental disorders or difficulty in cognition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A co-developed and iteratively optimized model X to achieve
an increase in:
Proportion of men and women aged 30 years and above
screened for oral cancer, and women aged 30 years and
above screened for breast and cervical cancer.
Proportion of screened positive men and women diagnosed
with oral cancer, and screened positive women diagnosed
with breast and cervical cancer.
Proportion of diagnosed men and women initiated on
treatment for oral cancer, and diagnosed women initiated on
treatment for breast and cervical cancer |
Baseline in Phase I at 6 months,
Endline in Phase III at 36 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better equipped health facilities for cancer screening , Trained manpower, Customized IEC both for community & providers, better community awareness on cancer |
3 years |
|
|
Target Sample Size
|
Total Sample Size="15785"
Sample Size from India="15785"
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)
|
03/11/2025 |
| 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
|
Background: Despite the implementation of the National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD), the coverage of screening for oral, breast, and cervical cancers remains significantly low. Further there is a delay in diagnosis and treatment initiation. Strengthening health systems is vital for providing accessible preventive cancer care. There a scarcity of comprehensive studies assessing barriers and enablers of cancer screening, facility readiness for cancer care and identifying referral barriers from primary to advanced care.
Objectives: This multisite study is designed within the context of NP-NCD in seven Indian districts across seven states with the following objectives: I) Assess current status, barriers, and facilitators in cancer screening, diagnosis, and treatment initiation; (II) Co-develop and optimizing the implementation model based on key performance indicators in sub-district populations; (III) Implement and evaluate the model across districts to recommend broader applications.
Methods: Utilizing a mixed-method implementation research design, the study will analyze screening, diagnosis, and treatment coverage for the three cancers and their determinants. It will also assess a proportion of facilities providing care for cancer at various levels and explore the cancer care pathway. A combination of quantitative surveys, qualitative interviews, and facility assessments will be used for baseline assessment and then to evaluate the outcomes. The study population will include a subset of the target population in the selected districts, health care providers (ASHA/ANM/CHO/MO, specialist), program officers, voluntary organizations, cancer patients and their caregivers.
Discussion: Based on the baseline assessment in Phase I, an evidence-based implementation model will be co-developed and iteratively optimized with various stakeholders from the state, district and community. This model would be implemented and further optimized during Phase II. The final model will be implemented across the districts to enhance the coverage of cancer screening, early diagnosis and treatment initiation in the targeted districts in Phase III. |