An interventional study of Systematic ePROMs Assessment in Neoplasms, Symptoms and Signs and Psychological Distress, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Not applicable, Interventional, and Health services research
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).
Study aims of this phase are:
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.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention: The intervention is constituted by a Systematic ePROMs Assessment in routine cancer care in a comprehensive cancer centre. This will involve preliminary sensitization and training of both clinicians and patients towards the use of ePROMs. Data filled in by patients through electronic devices will be prompt made available to the clinician during the patient examination.
Behavioral: Systematic ePROMs Assessment
Depending on the care setting, eligible patients will be asked to fill in one of the following e-PROMs assessment: Edmonton symptom assessment scale (ESAS-r) (outpatients) Distress Thermometer (inpatients) An ad hoc questionnaire adapted from the Bench-Can and EURACAN projects plus the institutional customer satisfaction survey (patients followed by multidisciplinary teams)
Proportion of patient compliant with ePROM assessment
Compliant patients are defined as patients successfully completing ePROM assessment.
Time frame: Baseline (one-time point only)
Proportion of clinical encounters using ePROM assessment
Clinical encounters using ePROM assessment are encounters in which the clinician gets access to symptom or psychological distress data collected by the patients through ePROM assessment
Time frame: Baseline (one-time point only)
Proportion of patient compliant with ePROM repeated assessments
Proportion patients who succesfully complete ePROMs assessments at each follow-up visit
Time frame: 6 months
Proportion of refusals
Proportion of patients refusing to use the system and reason for refusal
Time frame: Baseline (one-time point only)
Plan to share: No
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano