SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS

NCT ID: NCT04929353

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-20
• Study Completion Date: 2024-06-20

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).

Conditions

Melanoma; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Systematic symptom assessment

Intervention Type: OTHER

• Systematic symptom assessment
• Conventional symptom assessment

Arm B

Standard symptom reporting following the conventional modalities of clinical oncology practice

Group Type: OTHER

Systematic symptom assessment

Intervention Type: OTHER

• Systematic symptom assessment
• Conventional symptom assessment

Interventions

Systematic symptom assessment

• Systematic symptom assessment
• Conventional symptom assessment

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Of Perugia

OTHER

Sponsor Role: lead

Responsible Party

Roila Fausto

Professor of Medical Oncology at the University of Perugia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oncologia Medica, Azienda Ospedaliera Universitaria

Perugia, PG, Italy

Countries

Italy

Facility Contacts

ROILA FAUSTO

Role: primary

fausto.roila@unipg.it

+39 075 585 8167

CURRA MARIA FRANCESCA

Role: backup

mfrancesca.curra@ospedale.perugia

+39 075 578 4188

Other Identifiers

IRMA

Identifier Type: -

Identifier Source: org_study_id