SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS

Study Overview
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Brief Summary
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Immune-related adverse events (irAEs) can be different in their onset, kinetics and presentation but unlike chemotherapy are seldom predictable. Toxicity can affect nearly any organ system and multiple presentations of rare but severe irAEs have been reported, highlighting the relevance of vigilant monitoring. Although early detection and timely management of high grade or special interest irAEs (such as cardiac and neurological) is obvious, it is unclear whether early identification of less serious events can lead to clinical benefit. Furthermore, it is of the utmost importance to develop new tools which can increase identification of side effects. The current study investigates systematic symptom assessment through an electronic patient reported outcome tool and aims to define whether this can reduce the rate of serious irAEs.

Detailed Description
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Systematic collection of symptom information during immunotherapy treatment will be compared to usual care in locally advanced or metastatic lung cancer (NSCLC or SCLC) and surgically resected or advanced melanoma. Electronic survey will be administered every other day to report 14 common symptoms selected from the NCI-PRO-CTCAE TM library developed by the NATIONAL CANCER INSTITUTE (NATIONAL INSTITUTES OF HEALTH, Bethesda, Maryland) Italian version (NCI-PRO-CTCAETM ITEMS-ITALIAN-Item Library Version 1.0).

Official Title
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(ImmunotheRapy SyMptom CApture) A RANDOMIZED CONTROLLED TRIAL OF SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS

Conditions
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Melanoma, Lung Cancer

Intervention / Treatment
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* Other: Systematic symptom assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old at time of signing Informed Consent Form Histologically documented diagnosis of locally advanced or metastatic lung cancer (NSCLC or SCLC), surgically resected or advanced melanoma Patients eligible for immunotherapy in any line of treatment, either alone or in combination with other immunotherapy drugs or with chemotherapy Signed Informed Consent Form Life expectancy ≥3 months ECOG Performance Status of ≤2 Adequate hematologic and end-organ function, defined by laboratory test result by investigator's judgment Viral hepatitis screening: Negative hepatitis B surface antigen (HBsAg) test For patients with positive total HBcAb test, hepatitis B virus (HBV) DNA test is required For patients with positive HCV antibody test, hepatitis C virus (HCV) RNA test is required Exclusion Criteria: Patients receiving immunotherapy at time of enrollment > 1 grade adverse events from previous treatments Any uncontrolled symptom Clinically unstable brain metastases (i.e., symptomatic, not treated with RT and rapidly evolving)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ARM A<br>Self-Reporting by electronic survey consisting of 14 items selected by the NCI-PRO-CTCAE TM ITEMS-ITALIAN (Item Library Version 1.0) | Other: Systematic symptom assessment<br>* Systematic symptom assessment Conventional symptom assessment<br>|
| Other: Arm B<br>Standard symptom reporting following the conventional modalities of clinical oncology practice | Other: Systematic symptom assessment<br>* Systematic symptom assessment Conventional symptom assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Decrease rate of irAEs ≥ grade 3 according to CTCAEs (Common Terminology Criteria for Adverse Events) with systematic symptom assessment | The electronic questionnaire surveys 14 symptoms selected by the NCI-PRO-CTCAE TM ITEMS-ITALIAN (Item Library Version 1.0). The patient will rate their symptoms on a 5-point ordinal scale concerning the symptom frequency (never / rarely / sometimes / often / almost always), intensity (not at all / a little / quite / a lot / very much) and sometimes their interference with usual/daily activities (not at all / a little / quite / a lot / very much). The questionnaire must be collected from all patients (ARM A and ARM B) after randomization and before first treatment administration. Patients enrolled in ARM A must answer the questionnaire every other day. Alert will then be triggered when symptom level is not within the designated range. Following every activated alert, a physical examination and biochemical blood tests must be carried out. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Duration of irAEs ≥ grade 3 | Duration of irAEs ≥ grade 3 | 36 months | 
| 2. Emergency hospital admission | Emergency hospital admission | 36 months | 
| 3. Admission to and duration of hospitalization | Admission to and duration of hospitalization | 36 months |