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

NCT03968718 | Unknown

• 1 other identifier: Istitutotumori
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Patient Reported Outcome Measures; Feasibility study

Outcome Measures

Primary Outcomes (2)

• Proportion of patient compliant with ePROM assessment

  Compliant patients are defined as patients successfully completing ePROM assessment.

  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

  Baseline (one-time point only)

Secondary Outcomes (2)

• Proportion of patient compliant with ePROM repeated assessments

  6 months

• Proportion of refusals

  Baseline (one-time point only)

Study Arms (1)

Systematic ePROMs Assessment

EXPERIMENTAL

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

Interventions

Systematic ePROMs Assessment BEHAVIORAL

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)

Systematic ePROMs Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or above
• a verified cancer diagnosis

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milan, 20133, Italy

RECRUITING

Related Publications (2)

• Brunelli C, Alfieri S, Zito E, Spelta M, Arba L, Lombi L, Caselli L, Caraceni A, Borreani C, Roli A, Miceli R, Tine' G, Zecca E, Platania M, Procopio G, Nicolai N, Battaglia L, Lozza L, Shkodra M, Massa G, Loiacono D, Apolone G. Patient Voices: Multimethod Study on the Feasibility of Implementing Electronic Patient-Reported Outcome Measures in a Comprehensive Cancer Center. JMIR Cancer. 2025 Jan 22;11:e56625. doi: 10.2196/56625.

  PMID: 39842002 DERIVED

• 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.

  PMID: 32723341 DERIVED

MeSH Terms

Conditions

Neoplasms; Signs and Symptoms; Consumer Behavior

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Cinzia Brunelli, PhD

  Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinzia Brunelli, PhD

CONTACT

+390223903387; cinzia.brunelli@istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: May 30, 2019
• Study Start: May 27, 2019
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)