PATIENT VOICES Integration of Systematic Assessment of Patient Reported Outcomes Within Clinical Oncology Practice
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|ClinicalTrials.gov Identifier: NCT03968718|
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Symptoms and Signs Psychological Distress Satisfaction, Consumer Quality of Life||Behavioral: Systematic ePROMs Assessment||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||640 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2020|
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)
- Proportion of patient compliant with ePROM assessment [ Time Frame: Baseline (one-time point only) ]Compliant patients are defined as patients successfully completing ePROM assessment.
- Proportion of clinical encounters using ePROM assessment [ Time Frame: Baseline (one-time point only) ]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
- Proportion of patient compliant with ePROM repeated assessments [ Time Frame: 6 months ]Proportion patients who succesfully complete ePROMs assessments at each follow-up visit
- Proportion of refusals [ Time Frame: Baseline (one-time point only) ]Proportion of patients refusing to use the system and reason for refusal
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968718
|Contact: Cinzia Brunelli, PhDfirstname.lastname@example.org|
|Fondazione IRCCS Istituto Nazionale dei Tumori|
|Milano, Milan, Italy, 20133|
|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|
|Principal Investigator:||Cinzia Brunelli, PhD||Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy|