SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS (IRMA)
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|ClinicalTrials.gov Identifier: NCT04929353|
Recruitment Status : Not yet recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Lung Cancer||Other: Systematic symptom assessment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||(ImmunotheRapy SyMptom CApture) A RANDOMIZED CONTROLLED TRIAL OF SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS|
|Estimated Study Start Date :||June 20, 2021|
|Estimated Primary Completion Date :||June 20, 2023|
|Estimated Study Completion Date :||June 20, 2024|
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
Standard symptom reporting following the conventional modalities of clinical oncology practice
Other: Systematic symptom assessment
- 1. Decrease rate of irAEs ≥ grade 3 according to CTCAEs (Common Terminology Criteria for Adverse Events) with systematic symptom assessment [ Time Frame: 36 months ]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.
- 1. Duration of irAEs ≥ grade 3 [ Time Frame: 36 months ]Duration of irAEs ≥ grade 3
- 2. Emergency hospital admission [ Time Frame: 36 months ]Emergency hospital admission
- 3. Admission to and duration of hospitalization [ Time Frame: 36 months ]Admission to and duration of hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04929353