Catastrophic expenditure rates and barriers for treatment adherence in patients with colorectal cancer in India: The CROCODILE study protocol.

AIM: Little is known about the delivery of colorectal cancer treatment in India and its associated costs. The aim of this study is to identify financial and nonfinancial barriers to adherence to colorectal cancer treatment in India.

METHOD: CROCODILE is a mixed-methods study with a quantitative and a qualitative workstream. The quantitative workstream will be a prospective cohort study to assess treatment adherence and catastrophic expenditure rates among patients with colorectal cancer in India. Consecutive newly diagnosed patients with histopathologically proven colorectal cancer from five tertiary hospitals in India will be included. Catastrophic expenditure will be defined as a treatment cost higher than 40% of nonsubsistence annual household income. Treatment costs will include medical, nonmedical and indirect expenses. Income assessment will be compared between three methods: patient-reported income, the International Wealth Index and the Gapminder tool. The qualitative workstream will explore the views and experiences of colorectal cancer patients and professionals about barriers to and facilitators for treatment adherence. Individual semistructured interviews with three to five patients and cancer care professionals in each centre will be performed. An analytical framework will be developed to perform the analysis, through a combined approach (deductive and inductive). The results will be triangulated with the quantitative workstream for mutual knowledge enrichment.

CONCLUSION

The CROCODILE study will identify barriers to and facilitators for colorectal cancer delivery in India, influencing research and policy decisions. It will explore the feasibility of collecting data on patient-level costs and income to inform future economic evaluations in cancer and surgical care.