AzTrials
AzTrials

Patient Reported Outcome MeasuresIePRONCT05530187

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

A study testing Electronic Patient-reported Outcomes-based Model of Care in people with Patient Reported Outcome Measures and Patient Safety, run by Manuela Eicher at 2 sites in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Electronic Patient-reported Outcomes-based Model of Care
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
2 sitesSwitzerland
Study dates
2 Nov 2021to 2 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites, 2 recruiting

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

    Alfredo Addeo

    Not yet recruiting

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

    Manuela Eicher, +41795564606, manuela.eicher@chuv.ch

    Olivier Michielin

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read more

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.

Being tested
Electronic Patient-reported Outcomes-based Model of Care
Keywords
Patient-reported outcomes, Model of care, Remote symptom monitoring, Immune-related adverse events, PRO, IrAE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic Patient-reported Outcomes-based Model of CareDevice

    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).

Study groups in NCT05530187
Study groupRoleWhat they receive
ControlNo interventionNot described
InterventionExperimentalNot described
Receives: Device: Electronic Patient-reported Outcomes-based Model of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 6 months

Secondary outcomes (9)

  1. Number of symptomatic IrAEs experienced by patients

    Number, type and grade of diagnosed Symptomatic IrAEs.

    Measured: Up to 6 months

  2. Number of self-reported symptoms

    Type and number of self-reported PRO-CTCAE items.

    Measured: Up to 6 months

  3. Symptom-to-treatment interval

    Time (in days) between symptom onset and the first pharmacological intervention for the symptomatic IrAE.

    Measured: Up to 6 months

  4. IrAE treatments

    Number and type of documented pharmacological interventions to manage IrAEs.

    Measured: Up to 6 months

  5. Maximum IrAE grade

    Highest recorded IrAE grade according to the CTCAE version 5.0

    Measured: Up to 6 months

  6. 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)

    Measured: Up to 6 months

  7. 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)

    Measured: Up to 6 months

  8. Overall survival

    Overall survival at 6 months.

    Measured: Up to 6 months

  9. Triage process

    Type and amount of IrAE management actions/instructions issued by triage nurses, per resulting alerts (green, amber and red alerts).

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2022
  2. Study start2 Nov 2021
  3. Primary completion2 Nov 2023 (estimated)
  4. Study completion2 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05530187
Sponsor's protocol ID
IePRO
Acronym
IePRO
Status last verified
Sep 2022
First submitted
31 Aug 2022
Last updated
7 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lopes AMDS, Giacomini S, Ulahannan A, Darnac C, Bugeia S, Gutknecht G, Colomer-Lahiguera S, Spurrier-Bernard G, Latifyan S, Addeo A, Michielin O, Eicher M. Acceptability of an Electronic Patient-Reported Outcomes-Based Model of Care to Monitor Symptoms Related to Cancer Treatment with Immune Checkpoint Inhibitors: Results from the IePRO Randomized Controlled Trial. Semin Oncol Nurs. 2025 Aug;41(4):151903. doi: 10.1016/j.soncn.2025.151903. Epub 2025 May 24.

    PubMed 40413059

  • da Silva Lopes AM, Colomer-Lahiguera S, Darnac C, Giacomini S, Bugeia S, Gutknecht G, Spurrier-Bernard G, Cuendet M, Muet F, Aedo-Lopez V, Mederos N, Michielin O, Addeo A, Latifyan S, Eicher M. Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial. JMIR Res Protoc. 2023 Oct 18;12:e48386. doi: 10.2196/48386.

    PubMed 37851498

Questions about this trial

What is this clinical trial studying?

A study testing Electronic Patient-reported Outcomes-based Model of Care in people with Patient Reported Outcome Measures and Patient Safety, run by Manuela Eicher at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IrAE time-to-detection (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05530187, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in