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

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
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03968718
Enrollment
640
Registered
2019-05-30
Start date
2019-05-27
Completion date
2021-12-31
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Patient Reported Outcome Measures, Feasibility study

Brief 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).

Detailed 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.

Interventions

BEHAVIORALSystematic 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)

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age 18 years or above * a verified cancer diagnosis

Exclusion criteria

* inability to fill in PROMs due to cognitive impairment, psychological disturbance or language problems as judged by the study personnel.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patient compliant with ePROM assessmentBaseline (one-time point only)Compliant patients are defined as patients successfully completing ePROM assessment.
Proportion of clinical encounters using ePROM assessmentBaseline (one-time point only)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

Secondary

MeasureTime frameDescription
Proportion of patient compliant with ePROM repeated assessments6 monthsProportion patients who succesfully complete ePROMs assessments at each follow-up visit
Proportion of refusalsBaseline (one-time point only)Proportion of patients refusing to use the system and reason for refusal

Countries

Italy

Contacts

Primary ContactCinzia Brunelli, PhD
cinzia.brunelli@istitutotumori.mi.it+390223903387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026