Back to resultsSYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS (IRMA)
Primary Purpose
Melanoma, Lung Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Systematic symptom assessment
Sponsored by
About this trial
This is an interventional prevention trial for Melanoma
Eligibility Criteria
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)
Sites / Locations
- Oncologia Medica, Azienda Ospedaliera Universitaria
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ARM A
Arm B
Arm Description
Self-Reporting by electronic survey consisting of 14 items selected by the NCI-PRO-CTCAE TM ITEMS-ITALIAN (Item Library Version 1.0)
Standard symptom reporting following the conventional modalities of clinical oncology practice
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
1. Duration of irAEs ≥ grade 3
Duration of irAEs ≥ grade 3
2. Emergency hospital admission
Emergency hospital admission
3. Admission to and duration of hospitalization
Admission to and duration of hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04929353
Brief Title
SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS
Acronym
IRMA
Official Title
(ImmunotheRapy SyMptom CApture) A RANDOMIZED CONTROLLED TRIAL OF SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2021 (Anticipated)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Of Perugia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Lung Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARM A
Arm Type
Other
Arm Description
Self-Reporting by electronic survey consisting of 14 items selected by the NCI-PRO-CTCAE TM ITEMS-ITALIAN (Item Library Version 1.0)
Arm Title
Arm B
Arm Type
Other
Arm Description
Standard symptom reporting following the conventional modalities of clinical oncology practice
Intervention Type
Other
Intervention Name(s)
Systematic symptom assessment
Intervention Description
Systematic symptom assessment
Conventional symptom assessment
Primary Outcome Measure Information:
Title
1. Decrease rate of irAEs ≥ grade 3 according to CTCAEs (Common Terminology Criteria for Adverse Events) with systematic symptom assessment
Description
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
Secondary Outcome Measure Information:
Title
1. Duration of irAEs ≥ grade 3
Description
Duration of irAEs ≥ grade 3
Time Frame
36 months
Title
2. Emergency hospital admission
Description
Emergency hospital admission
Time Frame
36 months
Title
3. Admission to and duration of hospitalization
Description
Admission to and duration of hospitalization
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Oncologia Medica, Azienda Ospedaliera Universitaria
City
Perugia
State/Province
PG
ZIP/Postal Code
06132
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROILA FAUSTO
Phone
+39 075 585 8167
Email
fausto.roila@unipg.it
First Name & Middle Initial & Last Name & Degree
CURRA MARIA FRANCESCA
Phone
+39 075 578 4188
Email
mfrancesca.curra@ospedale.perugia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS
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