Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE®) in breast cancer patients: The prospective observational multicenter VIP study

Caterina Caminiti ¹, Giuseppe Maglietta ¹, Laura Arenare ²

¹Clinical and Epidemiological Research Unit, University Hospital, Parma, Italy.
²Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS Fondazione G.Pascale, Napoli, Italy.
³Division of Medical Oncology, Ospedale del Mare, Napoli, Italy.
⁴Departmental Structure of Clinical Psycho-oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy.
⁵Experimental and Clinical Senologic Oncology Unit, Istituto Nazionale Tumori, IRCCS Fondazione G.Pascale, Napoli, Italy.
⁶Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Napoli, Italy.
⁷Medical Oncology, ASST Rhodense, Rho (MI), Italy.
⁸Medical Oncology, Ospedale Guglielmo da Saliceto, Piacenza, Italy.
⁹Interdisciplinary Department of Medicine, Università degli Studi 'A. Moro', Bari, Italy; Polyclinic Consortium University Hospital, Bari, Italy.
¹⁰Medical Oncology, Ospedale Civile, Guastalla (RE), Italy.
¹¹Supportive Care Unit, istituto Nazionale Tumori, IRCCS, Milano, Italy.
¹²Medical Oncology, Ospedale S.Carlo, Potenza, Italy.
¹³Medical Oncology, Azienda ULSS 8 Nerica, Ospedale S.Bortolo, Vicenza, Italy.
¹⁴Medical Oncology, IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Internal Medicine and Medical Specialties (DIMI), Università di Genova, Genova, Italy.
¹⁵FAVO - Federazione Italiana delle Associazioni di Volontariato in Oncologia, Roma, Italy.
¹⁶Medical Oncology, AUSL-IRCCS, Reggio Emilia, Italy.

⁰Clinical and Epidemiological Research Unit, University Hospital, Parma, Italy.

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July 26, 2024

View abstract on PubMed

Summary

A selected list of Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) items effectively captures breast cancer patients' quality of life and side effects. This agile tool reduces patient burden in research and clinical practice.

Area Of Science

Oncology
Health Outcomes Research
Psychometrics

Background

Patient self-reporting is crucial for assessing quality of life and treatment side effects.
Redundancy in multiple patient-reported outcome instruments can overwhelm patients.
Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) offers direct patient reporting of side effects.

Purpose Of The Study

To evaluate the psychometric properties of a selected PRO-CTCAE item list in breast cancer patients.
To determine if PRO-CTCAE can serve as a standardized, agile tool for capturing patient-reported outcomes.
To assess the potential of PRO-CTCAE to reduce patient burden without compromising data relevance.

Main Methods

Psychometric properties of selected PRO-CTCAE items were tested in 303 breast cancer patients.
Convergent validity was assessed using the Hospital Anxiety and Depression Scale (HADS) and EORTC BR-23.
Responsiveness was evaluated using the Patients Global Impression of Change (PGIC) score.

Main Results

The selected PRO-CTCAE symptoms demonstrated convergent validity with HADS and EORTC BR-23.
The PRO-CTCAE items showed responsiveness correlating with the PGIC score.
Higher education levels correlated with shorter completion times for digital PRO-CTCAE questionnaires.

Conclusions

A selected list of PRO-CTCAE items is a standardized and agile tool for assessing side effects and quality of life in breast cancer patients.
This approach can reduce patient burden in both research and clinical settings.
PRO-CTCAE effectively captures essential patient-reported information on perceptions of health and treatment.

Keywords:

Breast cancer Convergent validity EORTC BR-23 Electronic PROMs (ePROMs) HADS PRO-CTCAE Patient-reported outcome measures (PROMs) Responsiveness

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