Clinical trial NCT05554432: Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2
Official title: Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
IMMUNE CHECKPOINT INHIBITOR
Quality of Life
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
References: