PATIENT VOICES Integration of Systematic Assessment of Patient Reported Outcomes Within Clinical Oncology Practice

Quality of Life Clinical Trial

Official title: PATIENT VOICES - A Project for the Integration of Systematic Assessment of Patient Reported Outcomes Within an E-Health Program in an Italian Comprehensive Cancer Center

Status Recruiting

Clinical Trial Summary

Listening to "patient voices" in terms of symptoms, emotional status, satisfaction with care and information received, represents a major shift in medicine. It is in fact crucial in medical decision making and patient empowerment, especially in cancer care.

Patient Reported Outcomes Measures (PROMs) and in particular electronically assessed PROMS (ePROMS), have been identified as potentially effective tools to systematically gather patient voices. Despite international extensive and growing interest, systematic PROM collection is not widely implemented in routine cancer care, due to barriers at various levels.

The PATIENT VOICES is a project aimed at achieving a stepwise inclusion and integration of PROMs within routine clinical practice at the FONDAZIONE IRCCS ISTITUTO NAZIONALE TUMORI-MILANO. Phase I of the Patient Voices project (pilot and feasibility testing), will be the focus of the present study and its results will be the base for subsequent phases (implementation and impact assessment).

Clinical Trial Description

Study aims of this phase are:

• Assessing the use and attitudes toward PROMs by clinicians in a comprehensive cancer centre.

• Reviewing and compare pre-existing ePROMS assessment systems.

• Developing and pilot testing a flexible system for electronic collection of PROMs.

• Assessing feasibility of ePROM assessment of physical symptoms, psychological distress and patient satisfaction.

• Identifying barriers to and developing strategies for the final implementation and integration of routine ePROMs into the clinical practice.

The project will last 2 years. Longitudinal and cross-sectional studies will be carried out with the aim to evaluate compliance, acceptability, and usability of a routine ePROM assessment system by both patients and clinicians. Participants will be enrolled among patients attending 3 out-patient clinics (physical symptom), 3 inpatient wards (psychological distress) and 5 multidisciplinary teams (patient satisfaction). The Edmonton symptom assessment scale, the Distress Thermometer, and a questionnaire adapted from the Bench-Can and EURACAN projects plus the institutional customer satisfaction survey, will be used in the three studies. Qualitative methods will be used identify patient and clinician related barriers to ePROM assessment and to pinpoint engagement strategies to promote its use in routine cancer care. Semi-structured interviews and focus groups will be carried out.

Quantitative and qualitative studies will respectively enroll 600 and 40 participants. ;

Related Conditions & MeSH terms

• Neoplasms
• Psychological Distress
• Quality of Life
• Satisfaction, Consumer
• Symptoms and Signs

• NCT number: NCT03968718
• Study type: Interventional
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Cinzia Brunelli, PhD
• Phone: +390223903387
• Email: cinzia.brunelli@istitutotumori.mi.it
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2019
• Completion date: December 2021