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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968718
• Other study ID #: Istitutotumori
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Cinzia Brunelli, PhD
• Phone: +390223903387
• Email: cinzia.brunelli[@]istitutotumori.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patient compliant with ePROM assessment	Compliant patients are defined as patients successfully completing ePROM assessment.	Baseline (one-time point only)
Primary	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	Proportion of patient compliant with ePROM repeated assessments	Proportion patients who succesfully complete ePROMs assessments at each follow-up visit	6 months
Secondary	Proportion of refusals	Proportion of patients refusing to use the system and reason for refusal	Baseline (one-time point only)