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

Abstract

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.

Tumori 2016; 102(2): 217 - 221

Article Type: CLINICAL TRIAL PROTOCOL

DOI:10.5301/tj.5000451

Authors

Silvia Riva, Ketti Mazzocco, Gabriella Pravettoni

Article History

Disclosures

Financial support: The study is supported by the University of Milan, which has received a limited grant from Novartis for supporting regulatory procedures.
Conflict of interest: None of the authors has any financial interest related to this study to disclose.

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Authors

Affiliations

  • Department of Oncology and Hemato-oncology, University of Milan, Milan - Italy
  • Applied Research Division for Cognitive and Psychological Sciences, European Institute of Oncology (IEO), Milan - Italy

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