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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
280
* Systematic symptom assessment * Conventional symptom assessment
Oncologia Medica, Azienda Ospedaliera Universitaria
Perugia, PG, Italy
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.
Time frame: 36 months
1. Duration of irAEs ≥ grade 3
Duration of irAEs ≥ grade 3
Time frame: 36 months
2. Emergency hospital admission
Emergency hospital admission
Time frame: 36 months
3. Admission to and duration of hospitalization
Admission to and duration of hospitalization
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.