SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS (IRMA)

• ClinicalTrials.gov Identifier: NCT04929353
• Recruitment Status: Not yet recruiting
• First Posted: June 18, 2021
• Last Update Posted: June 18, 2021
• Sponsor: University Of Perugia
• Information provided by (Responsible Party): Roila Fausto, University Of Perugia

Tracking Information

• First Submitted Date: May 31, 2021
• First Posted Date: June 18, 2021
• Last Update Posted Date: June 18, 2021
• Estimated Study Start Date: June 20, 2021
• Estimated Primary Completion Date: June 20, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 9, 2021)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 9, 2021)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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).
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Melanoma
• Lung Cancer

Intervention

Other: Systematic symptom assessment

• Systematic symptom assessment
• Conventional symptom assessment

Study Arms

• ARM A
  Self-Reporting by electronic survey consisting of 14 items selected by the NCI-PRO-CTCAE TM ITEMS-ITALIAN (Item Library Version 1.0)
  Intervention: Other: Systematic symptom assessment
• Arm B
  Standard symptom reporting following the conventional modalities of clinical oncology practice
  Intervention: Other: Systematic symptom assessment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 9, 2021): 280
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 20, 2024
• Estimated Primary Completion Date: June 20, 2023 (Final data collection date for primary outcome measure)

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:

  1. Negative hepatitis B surface antigen (HBsAg) test
  2. For patients with positive total HBcAb test, hepatitis B virus (HBV) DNA test is required
  3. 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04929353
• Other Study ID Numbers: IRMA
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Roila Fausto, University Of Perugia
• Original Responsible Party: Same as current
• Current Study Sponsor: University Of Perugia
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Of Perugia
• Verification Date: June 2021