Clinical trial NCT03968718: PATIENT VOICES Integration of Systematic Assessment of Patient Reported Outcomes Within Clinical Oncology Practice
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Symptoms and Signs
Psychological Distress
Satisfaction, Consumer
Quality of Life
Keywords: Patient Reported Outcome Measures
Feasibility study
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patient compliant with ePROM assessment
timeFrame: Baseline (one-time point only)
measure: Proportion of clinical encounters using ePROM assessment
timeFrame: Baseline (one-time point only)
Secondary outcomes:
measure: Proportion of patient compliant with ePROM repeated assessments
timeFrame: 6 months
measure: Proportion of refusals
timeFrame: Baseline (one-time point only)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Milan
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy
name: Cinzia Brunelli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunelli C, Borreani C, Caraceni A, Roli A, Bellazzi M, Lombi L, Zito E, Pellegrini C, Spada P, Kaasa S, Foschi AM, Apolone G; PATIENT VOICES study group. PATIENT VOICES, a project for the integration of the systematic assessment of patient reported outcomes and experiences within a comprehensive cancer center: a protocol for a mixed method feasibility study. Health Qual Life Outcomes. 2020 Jul 28;18(1):252. doi: 10.1186/s12955-020-01501-1.