Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2

Cancer Clinical Trial

— EORTC ICI  

Official title:

Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554432
• Other study ID #: IC 2022-03
• Status: Recruiting
• Start date: October 12, 2022
• Est. completion date: April 2025

Study information

• Verified date: November 2022
• Source: Institut Curie
• Contact: Anne BREDART, PhD
• Phone: 01 44 32 43 50
• Email: anne.bredart[@]curie.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Over the past 20 years, the views and experiences of patients in the field of oncology (through patient-reported outcomes, PROMs) have become increasingly important. When used in clinical trials, PROMs contribute to better detection and are used in clinical trials to improve the detection and management of treatment side effects. The Health-related quality of life assessments are widely used in oncology research, and the development of reliable and valid measurement instruments has become a major challenge. In this context, health-related quality of life in cancer patients covers various aspects (functional status, physical or psychological symptoms) and several cancer-specific measurement instruments have been developed, including the EORTC QLQ-C30 quality of life questionnaire. Among the different therapies used to treat cancers, immunotherapy with immune checkpoint inhibitors has been gaining momentum in recent years. Commonly used to treat a wide variety of cancers, it also has a wide range of known side effects. However, little is known about the health-related quality of life of patients patients who receive this therapy: specific self-questionnaires are almost non-existent or inadequate, not covering all the effects related to immune checkpoint inhibitor toxicity. As for the data currently collected, they suffer from methodological problems. In view of the increasing use of immune checkpoint inhibitors in cancer treatment, their known side effects and the lack of valid questionnaires specific to these treatments, it appears important to provide a valid questionnaire to take into account these impacts on the quality of life of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Patients :

Inclusion Criteria:

• Provision of written informed consent to participate in the study
• Has been diagnosed with cancer
• Either currently receiving, or has received in the previous 12 months, one of the

following:

• an anti-PD-1 or anti-PDL-1 agent as the sole immune checkpoint inhibitor treatment (at least three cycles)
• an anti-PD-1 or anti-PDL-1 agent in combination with an anti-CTLA-4 agent (at least one cycle)
• cytotoxic chemotherapy and an anti-PD-1 or anti-PDL-1 agent (at least three cycles)
• Aged =18 years

Exclusion Criteria:

• Has an additional primary cancer for which they are receiving systemic therapy
• Cognitive impairment which presents an obstacle to the completion of questionnaires or an interview
• Poor command of the locally dominant language, or an inability to read questions
• [Phase 1b only] Was interviewed for Phase 1a Healthcare professionals :

Inclusion Criteria:

• Holds, or has held, a professional clinical position which involves working directly with cancer patients who are in receipt of immune checkpoint inhibitors
• Is a medical oncologist, nurse specialist (or equivalent), psychologist, or social worker

Exclusion Criteria:

• Has met the inclusion criteria for <1 years

Related Conditions & MeSH terms

• Cancer
• IMMUNE CHECKPOINT INHIBITOR
• Quality of Life

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the need for an additional EORTC quality of life module, or item list, to measure health-related quality of life in cancer patients who have received or are receiving immune checkpoint inhibitors.	Provisional item list(s) of quality of life issues important to people treated with immune checkpoint inhibitors.; Development of a strategy for the measurement of health-related quality of life in cancer patients who have received immune checkpoint inhibitors, alongside existing EORTC quality of life scales for cancer patients.	At inclusion