Rationale and protocol of CML study: cognitive and emotional impact of discontinuation of therapy in patients with chronic myeloid leukemia.

INTRODUCTION: Discontinuation of therapy can be proposed to patients with chronic myelogenous leukemia (CML) who reach a sustained deep molecular response (DMR) for a minimum and stable period. Today, a considerable number of patients reach a sustained DMR, especially when they are treated with the latest drugs. Although new-generation treatments may provide significant improvement in terms of patient health and health-related quality of life, many patients are uncertain about discontinuation and may refuse a treatment switch.

METHODS: This study is an observational research project aimed at investigating, from a psychological point of view, possible cognitive and emotional components that can influence treatment discontinuation and treatment decisions in a cohort sample of 120 CML patients.

RESULTS: The expected results indicate that cognitive and emotional factors may influence decision-making in this setting and may prevent appropriate risk-and-benefit evaluation of new treatment approaches.

CONCLUSIONS: This is the first study that will analyze in depth all possible psychological variables that can interfere with the medical decision process of treatment discontinuation in CML, providing new insights for clinical practice.