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Trial Title:
ePRO-based Model of Care to Manage and Monitoring Symptoms of Cancer Patients Treated With Immune Checkpoint Inhibitors
NCT ID:
NCT05530187
Condition:
Patient Reported Outcome Measures
Patient Safety
Conditions: Keywords:
Patient-reported outcomes
Model of care
Remote symptom monitoring
Immune-related adverse events
PRO
IrAE
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Electronic Patient-reported Outcomes-based Model of Care
Description:
Patients in the intervention arm of this study will report symptoms weekly through an
electronic symptom questionnaire. For the first 3 months of the 6 month intervention,
they will reassess the reported symptoms daily. A team of oncology nurses will contact
patients by telephone if they declare a new or worsening symptom. The nurses will use a
triage algorithm to identify patient needs (self-care, remote follow-up or in-person
assessment).
Arm group label:
Intervention
Summary:
Immune checkpoint inhibitors (ICIs) can cause immune-related adverse events (IrAEs)
throughout and beyond treatment duration. These IrAEs can be varied and difficult to
predict, as they can involve almost any organ, regardless of where the primary tumor is
located. Treatment modality and individual characteristics appear to influence the
frequency and severity of these events, which can become serious without proper
monitoring and timely intervention.
Generally, patient visits are scheduled at the same intervals in which patients receive
treatment, once every two to four weeks. In these large intervals, patients can be
surprised by IrAEs without a close schedule visit to their oncology physician. Not only
this may negatively influence their overall well-being, their perceived self-efficacy to
manage their own condition and their health-related quality of life may be affected as
well.
Using patient-reported outcomes (PROs) to monitor patient symptoms has become incredibly
valuable in describing treatment toxicity, including that of ICIs. PROs are a self-report
of the patient's own perceptions of their health status. Using their own words, or by
replying to questionnaires, patients can convey symptoms and how these affect their daily
life and quality of life.
Questionnaires are an example of a PRO measure (PROM), which have increasingly been
provided electronically (resulting in electronic PROs or ePROs). The ubiquity of
connected electronic devices has enabled long-distance monitoring of symptoms through
electronic questionnaires. In patients treated with chemotherapy, studies have shown that
using this method to collect symptom data can enable healthcare providers to help
patients manage their symptoms remotely. This allows patients to receive timely support
from home, that could help prevent serious complications that could entail visits to the
emergency department, unscheduled hospitalizations and treatment interruptions.
The IePRO study's aim is to test a model of care that uses electronic questionnaires to
monitor symptoms that could be related to the use of ICIs. Patients would reply to these
questionnaires at least once a week using an electronic web application (on their phone
or computer). A team of oncology nurses reviews their replies and calls patients when new
symptoms appear or when they worsen. Using a standard triage algorithm, the nurses guide
patients on how to proceed: if they should stay home and follow self-care advice, if they
should have a second call within the next 24 hours to follow-up on their symptoms, or if
they should come to the hospital for an in-person assessment as soon as possible.
In this study, it is hypothesized that this model of care could lead to an earlier
detection of IrAEs, as well as their improved management by reducing the number of
high-severity IrAEs, the number of unscheduled emergency admissions and hospitalizations,
as well as decreasing the number of treatment interruptions and of immunosuppressive
treatments used to treat IrAEs.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients 18 years old or older
- Patients diagnosed with cancer
- Patients starting or re-starting systemic ICI therapy treatments (adjuvant,
neo-adjuvant, metastatic)
- Informed Consent as documented by signature
Exclusion Criteria:
- Patients that self-declare not being able to use an ePRO application and complete a
questionnaire in French.
- Patients with any psychological, familial or sociological condition and linguistic
limitation potentially hampering compliance with the study protocol requirements
and/or follow-up procedures. These conditions will be discussed between the
recruiting oncologist and the patient before trial entry.
- Patients that are re-starting ICI therapy, but that have previously participated in
this intervention.
- Patients with a cognitive impairment, as declared in the patient record
- Patients participating in other interventional clinical studies.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire Vaudois
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Manuela Eicher
Phone:
+41795564606
Email:
manuela.eicher@chuv.ch
Investigator:
Last name:
Olivier Michielin
Email:
Principal Investigator
Facility:
Name:
Hôpitaux Universitaires de Genève
Address:
City:
Geneva
Zip:
1205
Country:
Switzerland
Status:
Not yet recruiting
Investigator:
Last name:
Alfredo Addeo
Email:
Principal Investigator
Start date:
November 2, 2021
Completion date:
November 2, 2023
Lead sponsor:
Agency:
Manuela Eicher
Agency class:
Other
Source:
University of Lausanne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05530187
