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

Sponsor
Institut Curie (Other)
Overall Status
Recruiting
CT.gov ID
NCT05554432
Collaborator
(none)
43
1
29.6
1.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    43 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2
    Actual Study Start Date :
    Oct 12, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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. [At inclusion]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Curie Paris France 75005

    Sponsors and Collaborators

    • Institut Curie

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut Curie
    ClinicalTrials.gov Identifier:
    NCT05554432
    Other Study ID Numbers:
    • IC 2022-03
    First Posted:
    Sep 26, 2022
    Last Update Posted:
    Nov 3, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 3, 2022