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临床试验/CTRI/2025/08/092632
CTRI/2025/08/092632尚未招募不适用

CAPTURE: Cancer Awareness and screening Promotion Through Utilization of community Resources and their Empowerment.

University of Luxembourg2 个研究点 分布在 1 个国家目标入组 2,785 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,785
试验地点
2
主要终点
1. At least 60% of participants in the intervention group will demonstrate an improvement in knowledge scores from baseline to post-intervention.

研究概览

简要总结

Title:

CAPTURE: Cancer Awareness and screening Promotion Through Utilization of community Resources and their Empowerment

Brief Summary:

CAPTURE is a multi-site implementation research project aimed at improving breast and cervical cancer screening uptake in India. The study will identify barriers to screening and implement theory-based educational interventions across three sectors: community-based organizations, academic institutions, and tertiary hospitals. It will be conducted over 24 months, from November 2025 to November 2027 (Inititaion based on HMSC approval obtained), led by the University of Luxembourg in collaboration with Father Muller College of Nursing and Kasturba Medical College, Mangalore. Ethical approvals have been obtained from all participating institutions.

The study includes two main phases. In Phase 1, barriers to screening uptake and early diagnosis will be assessed using the Barrier Assessment Questionnaire for Screening Uptake (BAQSU), developed based on integrated behavioral models including the Health Belief Model, Theory of Planned Behavior, and Theory of Care Seeking Behavior, structured using the DOST framework. This tool will be administered to three target groups: men and women aged 30 to 60 in the community, university students aged 20 to 25, and patients diagnosed with breast or cervical cancer in hospitals, to explore delay in diagnosis and treatment.

In Phase 2, sector-specific educational interventions will be implemented. In the community, educational camps will be delivered using lectures, flipcharts, and video modules led by gynecologists and public health experts. In university settings, students will receive video-based sessions followed by expert-led discussions and creative reinforcements such as music concerts. In hospitals, nurses will deliver short one-on-one awareness sessions using flipcharts for women visiting outpatient departments. Each session will be followed by the distribution of informational handouts with referral information to free screening centers. Screening behavior will be followed up at 3 and 6 months post-intervention.

The primary objective is to assess the demographic, psychosocial, and system-related barriers to cancer screening across the three sectors, and to develop and evaluate tailored educational interventions targeting these barriers. Secondary objectives include measuring behavior change and motivation for screening at follow-up and refining tools such as the BAQSU and educational content based on participant and implementer feedback.

It is expected that 60 percent of intervention participants will show improved knowledge and attitudes post-intervention, and that 50 percent of eligible or referred women will undergo screening within 3 to 6 months. The study will not collect any clinical samples. Only self-reported knowledge, attitudes, and behavioral intentions will be assessed. No personal identifying data will be collected, and informed consent will be obtained from all participants. Study sites will be finalized only after obtaining permission from local authorities. All data will be anonymized. The project has obtained all necessary ethical approvals, and formal collaborations have been signed between the institutions involved.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Cross sectional Survey in community(Phase 1): Men and women in general population and in university college, Physically and mentally healthy, able to provide consent, knows local language will be include in the participation in survey.
  • The survey will assess knowledge , general beliefs and attitude towards health related practices and choices, knowledge about cancer and cancer screening.
  • PHASE2-Educational Intervention (in community): An educational intervention will target women aged 30-60 years though community organizations that provide consent.
  • Women will be invited through announcements.
  • Those illing to voluntarily participate will be included.
  • Phase 2-Educational intervention (in university college):This phase will invite students(males and females) to participate in cancer awareness intervention.
  • Those willing to participate will be included in the study.
  • Educational intervention in (hospital settings): Women aged 30-60 years attending hopsitals for reasons will be approached by trained Nursing students and those willing to participate, know the language, provide consent will be included.
  • Assessing cancer delay diagnosis: Individuals admitted or attending hospital, diagnosed with cervical or breast cancer will be approached and consent will be obtained.
  • Those willing to participate will be included to collect information through a interviewer administered survey.
  • Participants will be included irrespective of age.

排除标准

  • Individuals physically or mentally challenged, those unable to provide consent, or in terminal stage with palliative care will not be included.

结局指标

主要结局

1. At least 60% of participants in the intervention group will demonstrate an improvement in knowledge scores from baseline to post-intervention.

时间窗: T0 – Baseline: | Before the intervention (for knowledge, beliefs, and attitudes) | T1 – Immediately Post-Intervention: | After the intervention (to assess improvement in knowledge and attitude using post-test form)

次要结局

  • 2. Atleast 50% women attending the awareness campaign will voluntarily seek screening for breast and cervical cancer.(T2 – Follow-up at 3 and 6 Months Post-Intervention:)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Jyotsna Coelho

Father Muller Medical College Hospital

研究点 (2)

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