ePRO-based Model of Care to Manage and Monitoring Symptoms of Cancer Patients Treated With Immune Checkpoint Inhibitors (IePRO)

Testing a Model of Care Based on Electronic Patient Reported Outcome Monitoring for Patients With Cancer Under Immune-checkpoint Blockade: A Phase II Study (IePRO Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Reported Outcome Measures; Patient Safety
• Intervention / Treatment: Device: Electronic Patient-reported Outcomes-based Model of Care

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Not yet recruiting
    • Hôpitaux Universitaires de Genève
    • Principal Investigator: Alfredo Addeo
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois
      • Principal Investigator: Olivier Michielin
      • Contact: Manuela Eicher; Phone Number: +41795564606; Email: manuela.eicher@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Device: Electronic Patient-reported Outcomes-based Model of Care; 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).
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IrAE time-to-detection	The primary outcome is the difference (in days) between the symptom onset date and the date when it was detected by the oncology team.	Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of symptomatic IrAEs experienced by patients	Number, type and grade of diagnosed Symptomatic IrAEs.	Up to 6 months
Number of self-reported symptoms	Type and number of self-reported PRO-CTCAE items.	Up to 6 months
Symptom-to-treatment interval	Time (in days) between symptom onset and the first pharmacological intervention for the symptomatic IrAE.	Up to 6 months
IrAE treatments	Number and type of documented pharmacological interventions to manage IrAEs.	Up to 6 months
Maximum IrAE grade	Highest recorded IrAE grade according to the CTCAE version 5.0	Up to 6 months
Health-related Quality of Life score measured with the FACT-G questionnaire	Change from baseline in health-related quality of life (weekly and at 6 months)	Up to 6 months
Self-efficacy score as measured with the PROMIS Self-Efficacy for Managing Symptoms short form 8a questionnaire	Change from baseline in perceived self-efficacy to manage symptoms (weekly and at 6 months)	Up to 6 months
Overall survival	Overall survival at 6 months.	Up to 6 months
Triage process	Type and amount of IrAE management actions/instructions issued by triage nurses, per resulting alerts (green, amber and red alerts).	Up to 6 months

Collaborators and Investigators

• Sponsor: Manuela Eicher

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Anticipated): November 2, 2023
• Study Completion (Anticipated): November 2, 2023

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: PRO; Model of care; Patient-reported outcomes; Immune-related adverse events; Remote symptom monitoring; IrAE
• Other Study ID Numbers: IePRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No