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Italian version of the Edmonton Symptom Assessment System (ESAS)–Total Care (TC): development and psychometric validation in patients undergoing cancer treatment or follow-up

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Abstract

Introduction

The routine use of patient-reported outcomes (PROs) in clinical practice improves quality of care, it helps in reducing the access to emergency services and unscheduled visits, and it can improve cancer patients’ time survival. The Edmonton Symptom Assessment System (ESAS) is a PRO largely used in different care settings to monitor physical and psychological symptoms. Nonetheless, along with these symptoms, literature also highlighted the presence and effect of spiritual pain, financial distress, and social isolation on quality of care, treatment effectiveness, and survival.

Aim

The aims of the current study were (a) to complete the Italian version of the ESAS validation process by adding the missing symptom “insomnia” and (b) to develop and validate the ESAS–Total Care (ESAS-TC) that is intended to evaluate and screen not only physical and psychological symptoms but also spiritual pain, discomfort deriving from financial problems associated with illness, and suffering related to social isolation.

Methods

A sample of Italian native outpatients, who referred to the dedicated Supportive Care Unit of the Fondazione IRCCS, Istituto Nazionale deiTumori (INT), Milano, were asked to fill the ESAS-TC to assess item properties, factorial structure, internal consistency, test–retest reliability (patients were asked to retake the scale after 2–6 weeks), and external validity. Concerning the latter, other self-administered scales were employed to assess perceived stress (Perceived Stress Scale), unmet needs (using theNeed Evaluation Questionnaire that describes informative, assistance/care, relational, needs for psycho-emotional support, material needs), and perceived social support (administering the Multidimensional Scale of Perceived Social Support that evaluates perceived support of family, friends, and significant others in the wider social field).

Results

The scales were administered to 243 patients with solid (90%) and hematologic (10%) cancers, mean age 62.6, female 76.5%. Analysis suggested that a single factor better represents the structure of the ESAS scales, their internal consistency and test–retest reliability were good, and evidence of construct and criterion validity were provided. Additionally, incremental validity of the ESAS-TC was proved showing that the added items offer a unique contribution in predicting the patient’s stress. Finally, known groups validity was confirmed testing the differences in the ESAS scores due to the Karnofsky Performance Status.

Conclusions

The current study allowed to complete the validation of the Italian version of the ESAS and to develop a psychometrically sound scale, the ESAS-Total Care, that potentially helps in moving cancer research toward personalized total cancer care.

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Code availability

Not applicable.

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Author information

Authors and Affiliations

  1. Department of Medical Oncology and Haematology, Oncology-Supportive Care Unit, Fondazione IRCCS, Istituto Nazionale Tumori Di Milano, 20133, Milan, Italy

    Carla Ripamonti, Giulia De Feo, Patricia Di Pede, Luisa Toffolatti & Mauro Guglielmo

  2. Medical Oncology Unit, Fondazione IRCCS, Istituto Nazionale Tumori Di Milano, 20133, Milan, Italy

    Rita Leporati

  3. Azienda USL Toscana Centro, UDS Cure Palliative Prato Pistoia, Firenze, Italy

    Domenico La Carpia

  4. Epidemiologia Clinica e Di Supporto Al Governo Clinico, Istituto Per lo Studio, la Prevenzione e la Rete Oncologica-ISPRO, Firenze, Italy

    Guido Miccinesi

  5. Department of Neuroscience and Child’s Health (NEUROFARBA), University of Florence, Florence, Italy

    Francesca Chiesi

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  1. Carla Ripamonti
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Contributions

CR and GM contributed to the conceptualization and planning of the study, and to the writing; FC analyzed and interpreted the data, supervised the project, and the paper conceptualization and writing. All the other authors contributed to patients recruitment, and read and approved the final version of the manuscript.

Corresponding author

Correspondence to Carla Ripamonti.

Ethics declarations

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Ethic Committee of Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy, protocol number: INT 248/20) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Not applicable.

Competing interests

The authors declare no competing interests.

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Ripamonti, C., Leporati, R., De Feo, G. et al. Italian version of the Edmonton Symptom Assessment System (ESAS)–Total Care (TC): development and psychometric validation in patients undergoing cancer treatment or follow-up. Support Care Cancer 30, 1923–1933 (2022). https://doi.org/10.1007/s00520-021-06594-y

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