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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05530187

Studienbeginn:
November 2021

Letztes Update:
07.09.2022

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Manuela Eicher

Collaborator:
-

Studienlocations
(2 von 2)

Centre Hospitalier Universitaire Vaudois
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Manuela Eicher
Phone: +41795564606
E-Mail: manuela.eicher@chuv.ch» Ansprechpartner anzeigen

Hôpitaux Universitaires de Genève
1205 Geneva
SwitzerlandNoch nicht rekrutierend» Google-Maps

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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

Secondary outcome:

1. Number of symptomatic IrAEs experienced by patients (Time Frame - Up to 6 months):
Number, type and grade of diagnosed Symptomatic IrAEs.

2. Number of self-reported symptoms (Time Frame - Up to 6 months):
Type and number of self-reported PRO-CTCAE items.

3. Symptom-to-treatment interval (Time Frame - Up to 6 months):
Time (in days) between symptom onset and the first pharmacological intervention for the symptomatic IrAE.

4. IrAE treatments (Time Frame - Up to 6 months):
Number and type of documented pharmacological interventions to manage IrAEs.

5. Maximum IrAE grade (Time Frame - Up to 6 months):
Highest recorded IrAE grade according to the CTCAE version 5.0

6. Health-related Quality of Life score measured with the FACT-G questionnaire (Time Frame - Up to 6 months):
Change from baseline in health-related quality of life (weekly and at 6 months)

7. Self-efficacy score as measured with the PROMIS Self-Efficacy for Managing Symptoms short form 8a questionnaire (Time Frame - Up to 6 months):
Change from baseline in perceived self-efficacy to manage symptoms (weekly and at 6 months)

8. Overall survival (Time Frame - Up to 6 months):
Overall survival at 6 months.

9. Triage process (Time Frame - Up to 6 months):
Type and amount of IrAE management actions/instructions issued by triage nurses, per resulting alerts (green, amber and red alerts).

Studien-Arme

No Intervention: Control
Experimental: Intervention

Geprüfte Regime

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).

Quelle: ClinicalTrials.gov

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