Improving Survival in Childhood Acute Lymphoblastic Leukemia in India (ISCALL): ICiCLE Implementation Study.
● Principal Investigator: Dr Venkatraman Radhakrishnan
To address disparities in ALL care and outcomes.
● Principal Investigators (PIs) and Co-Principal Investigators (Co-PIs) from 21 spokes and 6 hubs.
● Project staff including the project manager, nurses, clinical pharmacist, and data manager who are actively involved in the ISCALL study at hubs and spokes.
● Primary caregivers of pediatric patients diagnosed with Acute Lymphoblastic Leukemia (ALL) who received treatment for at least one year under the ISCALL study at the spoke centers.
● Stakeholders of the study comprise the Indian Council of Medical Research (ICMR), NGO partners, and the administrative team (Nodal Centre and CTSU)
● Project staff not directly involved in the ISCALL study are based outside the designated hubs and spokes.
● Institution staff who do not officially contribute to the ISCALL study, including those from institutions not participating in the project.
● Primary caregivers who do not have pediatric patients diagnosed with Acute Lymphoblastic Leukemia (ALL) or whose children do not receive treatment under the ISCALL study.
● Pediatric patients and their caregivers who have opted out or have been withdrawn from the ISCALL project for any reason.
● Staff or caregivers who are unable or unwilling to comply with the study protocols or provide informed consent.
● Build capacity and expertise in regional cancer hospitals for managing pediatric acute lymphoblastic leukemia thereby improving survival outcomes.
● Identify barriers and enablers of implementing the ICiCLe-1 protocol in selected public hospitals.
Firstly, the ICiCLe implementation project is a collaborative effort involving multiple healthcare institutions across India. This collaborative approach is critical for addressing the many challenges associated with childhood cancer management in India, including the lack of access to appropriate treatment and the shortage of trained healthcare providers. Secondly, the ICiCLe protocol itself is a novel approach to the treatment of childhood ALL in India. It is based on international treatment guidelines but has been adapted to the Indian healthcare system. This protocol is designed to be cost-effective and feasible for implementation in resource-limited settings, making it a valuable tool for improving the management of childhood ALL in India. Thirdly, the ICiCLe implementation project is unique in its focus on improving community engagement and awareness about childhood cancer. This includes initiatives to address cultural beliefs and practices that may affect the uptake of treatment, such as the use of traditional or alternative therapies. By engaging with communities and promoting awareness about childhood cancer, the project aims to increase the number of patients who seek appropriate treatment and adhere to it.
A hub and spoke model will be followed. The ICiCLe -1 centers (Cancer Institute Chennai, IRCH AIIMS New Delhi, Pediatrics AIIMS New Delhi, TMH Mumbai, PGI Chandigarh, and TMC Kolkata) will be the hubs and they will mentor centers (spoke). The hub and spoke model will cover all corners of India and will ensure penetration into tier 2 and 3 cities. Each hub will be asked to identify sites in their region that they would like to mentor and supervise. Hubs will not enroll patients in the study. The spokes will enroll patients in the study and under guidance from the hub. The hub will mentor, supervise, and help in the capacity building for managing pediatric ALL in the spokes.
Implementation of the ICICLE1 protocol for treating pediatric ALL across major public hospitals in India will improve the outcome of pediatric ALL in India. It will lead to capacity building, reduced treatment abandonment, and collaborative research.