Co-designing and evaluation of a context-appropriate strategy to improve access to early detection and care of oral, breast and cervical cancers in rural India: a formative phase implementation research protocol.

Background: In India, cancers of oral cavity, breast and cervix account for more than one-third of all cancers among the Indian population and cause nearly 0.25 million deaths every year in the country. Cancer has a catastrophic impact on the rural men and women of India, the majority of whom are socioeconomically disadvantaged with one-fifth living below the national poverty line. The cancer early detection strategies adopted in India today remain suboptimal. The Access Cancer Care India (ACCI) project aims to design and evaluate a new multilevel strategy, integrated and contextualised to the local health system, to improve access to the early detection and care continuum for oral, breast and cervical cancers among the rural population in India. Methods: We propose to conduct an effectiveness-implementation hybrid research study in three distinct states of India, focusing on the rural population residing in each state. The study's objectives will be addressed through a series of interrelated and sequential six work packages that encompass stakeholder and policy analysis, a mixed-method study to evaluate barriers and facilitators in accessing early detection services, a health system capacity assessment, a pilot implementation and evaluation and, finally, a determination of the readiness to sustain and scale the strategy. A pragmatic effectiveness-implementation hybrid design will be employed. The study has been granted regulatory clearance by the Health Ministry Screening Committee of India and obtained ethical approval from all collaborating institutions. Discussion: The ACCI project aims to establish a feasible early detection strategy for breast, cervical and oral cancers, recognizing that successful implementation and sustainability depend on stakeholder engagement, contextual analysis, capacity assessment and readiness for change. The proposed pragmatic study design addresses the challenges faced by policymakers and program managers in making evidence-based decisions. The insights gained from this study will be invaluable for other LMICs that share similar resource constraints and healthcare infrastructure challenges. Clinical Trial Registry India: CTRI/2022/09/045927.