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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
Sponsor:
Information provided by (Responsible Party):
Cinzia Brunelli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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).


Condition or disease Intervention/treatment Phase
Neoplasms Symptoms and Signs Psychological Distress Satisfaction, Consumer Quality of Life Behavioral: Systematic ePROMs Assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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)





Primary Outcome Measures :
  1. Proportion of patient compliant with ePROM assessment [ Time Frame: Baseline (one-time point only) ]
    Compliant patients are defined as patients successfully completing ePROM assessment.

  2. 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


Secondary Outcome Measures :
  1. Proportion of patient compliant with ePROM repeated assessments [ Time Frame: 6 months ]
    Proportion patients who succesfully complete ePROMs assessments at each follow-up visit

  2. Proportion of refusals [ Time Frame: Baseline (one-time point only) ]
    Proportion of patients refusing to use the system and reason for refusal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Cinzia Brunelli, PhD +390223903387 cinzia.brunelli@istitutotumori.mi.it

Locations
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Italy
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         
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Cinzia Brunelli, PhD Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cinzia Brunelli, Principal Investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03968718    
Other Study ID Numbers: Istitutotumori
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cinzia Brunelli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
Patient Reported Outcome Measures
Feasibility study