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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Unknown

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

Treatments: Behavioral: Systematic ePROMs Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT03968718

Istitutotumori

Details and patient eligibility

About

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).

Full 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.

Enrollment: 640 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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640 participants in 1 patient group

Systematic ePROMs Assessment

Experimental group

Description:

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.

Treatment:

Behavioral: Systematic ePROMs Assessment