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

NCT05554432 | Unknown

• 1 other identifier: IC 2022-03
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; IMMUNE CHECKPOINT INHIBITOR; Quality of Life

Outcome Measures

Primary Outcomes (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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population is individuals aged over 18, with a diagnosis of cancer, who have received or are receiving treatment with one of the following: * anti-PD-1 (e.g., nivolumab, pembrolizumab, cemiplimab) or anti-PDL-1 (e.g., atezolizumab, avelumab, durvalumab) only * anti-PD-1 + anti-CTLA-4 (e.g., nivolumab + ipilumumab) only * anti-PD-1/anti-PDL-1 + chemotherapy Experienced HCPs who have worked with patients who have received or are receiving ICIs will be eligible for inclusion, in line with the EORTC QLG guidelines which state that HCPs should be interviewed for their views on HRQoL issues affecting these patients.

You may qualify if:

• 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

You may not qualify if:

• 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 :
• 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Anne BREDART, PhD

CONTACT

01 44 32 43 50; anne.bredart@curie.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: October 12, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

FR (1)