跳至主要内容
临床试验/CTRI/2025/08/092672
CTRI/2025/08/092672尚未招募不适用

Implementation Research to Enhance Screening, Early Diagnosis and Initiation of Treatment for Oral, Breast and Cervical Cancer in Selected Districts of India

Indian Council of Medical Research (ICMR), New Delhi8 个研究点 分布在 1 个国家目标入组 15,785 人开始时间: 2025年11月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15,785
试验地点
8
主要终点
A co-developed and iteratively optimized model X to achieve

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Household Survey: Any man or woman aged 30 years or above.
  • Cancer care pathway: Diagnosed or on treatment cancer patients and their caregivers.
  • 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
  • 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.

排除标准

  • People who did not give consent to participate in the study
  • Anyone with mental disorders or difficulty in cognition.

结局指标

主要结局

A co-developed and iteratively optimized model X to achieve

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

an increase in:

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

Proportion of men and women aged 30 years and above

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

screened for oral cancer, and women aged 30 years and

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

above screened for breast and cervical cancer.

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

Proportion of screened positive men and women diagnosed

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

with oral cancer, and screened positive women diagnosed

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

with breast and cervical cancer.

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

Proportion of diagnosed men and women initiated on

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

treatment for oral cancer, and diagnosed women initiated on

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

treatment for breast and cervical cancer

时间窗: Baseline in Phase I at 6 months, | Endline in Phase III at 36 months

次要结局

  • Better equipped health facilities for cancer screening , Trained manpower, Customized IEC both for community & providers, better community awareness on cancer(3 years)

研究者

发起方
Indian Council of Medical Research (ICMR), New Delhi
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Tanvir Kaur

ICMR hqrs

研究点 (8)

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