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

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 Overview

• Status: Recruiting
• Conditions: Neoplasms; Quality of Life; Psychological Distress; Symptoms and Signs; Satisfaction, Consumer
• Intervention / Treatment: Behavioral: Systematic ePROMs 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.

• Study Type: Interventional
• Enrollment (Anticipated): 640
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cinzia Brunelli, PhD; Phone Number: +390223903387; Email: cinzia.brunelli@istitutotumori.mi.it

Study Locations

• Italy
  • Milan
    • Milano, Milan, Italy, 20133
      • Recruiting
      • Fondazione Irccs Istituto Nazionale Dei Tumori
      • Principal Investigator: Cinzia Brunelli, PhD
      • Sub-Investigator: Claudia Borreani, PsyD
      • Sub-Investigator: Marco Bellazzi, EngD
      • Sub-Investigator: Augusto Caraceni, MD
      • Sub-Investigator: Anna Roli, RN
      • Sub-Investigator: Giovanni Apolone, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Systematic ePROMs Assessment; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patient compliant with ePROM repeated assessments	Proportion patients who succesfully complete ePROMs assessments at each follow-up visit	6 months
Proportion of refusals	Proportion of patients refusing to use the system and reason for refusal	Baseline (one-time point only)

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Investigators: Principal Investigator: Cinzia Brunelli, PhD, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 27, 2019
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (ACTUAL): May 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Feasibility study; Patient Reported Outcome Measures
• Other Study ID Numbers: Istitutotumori

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No