Gender Neutral
Type Module
Testing Phase I / II - in development
Principal investigator(s)
Simone Oerlemans
Netherlands Comprehensive Cancer Organization (IKNL)
Eindhoven, Netherlands
, Charalampia Kyriakou
University College London Hospital
London, United Kingdom
Study coordinator(s)
Kyra Michielsen
IKNL
Eindhoven, Netherlands

Project summary

The EORTC Quality of Life Group has initiated the Phase I-II development of an international health-related quality of life module for patients with haematological malignancies treated with chimeric antigen receptor (CAR) T-cell therapy or T-cell engaging antibodies. Phase I includes a literature review and interviews with healthcare professionals and patients. The aim is to compile a comprehensive list of relevant quality of life issues for patients treated with CAR T-cell therapy or T-cell engaging antibodies. Phase II involves converting the selected issues into items.

We are currently at the end of Phase I and have started Phase II. We compiled a comprehensive list of 99 issues. The issue list is based on literature, clinical expertise, discussion groups, conversations with patients and representatives from patient organisations, and on the results from completed HCP interviews which were conducted in Germany, Croatia, Portugal, Australia, and the Netherlands.

Currently all HCP interviews and patient interviews conducted in all participating countries (Australia, Croatia, France, Germany, Portugal, the UK, the Netherlands) are finished.

Patients were asked to share their experiences with CAR T-cell therapy or T-cell engaging antibodies. They were also asked to review the issue list and to score each issue on relevance and importance. Additionally, they could indicate which issues they felt were missing, which issues were redundant, and which issues should be reworded.

In addition, we are conducting a systematic literature review to identify which patient-reported outcome measures (PROMs) have been used, at which timepoints they have been used, and which PROM domains have been affected most in patients with haematologic malignancies treated with CAR T-cell therapy of T-cell engaging antibodies.

In Phase II, all included issues will be converted to items. We just started with this phase.

Achievements

An issue list of 99 quality of life issues has been created. The health care professional and patient interviews are completed in Australia, Croatia, France, Germany, Portugal, The UK and the Netherlands. Based on these interviews, analyses have been performed to see which issues are most important to patients.

Currents status:

We are currently at the end of Phase I, in which we are selecting all important issues for the provisional module. We have also started with the conversion of issues into items, which is Phase II.

Future plans

We plan to finalize the inclusion of important issues during the EORTC QLG Spring Meeting 2026 in Berlin. After this meeting, we will finalize the conversion to items and the report. The plan is to finalize the report at the end of May.

 

For patients

The EORTC Quality of Life Group is making an international questionnaire about quality of life for patients with lymphoma and blood cancers treated with new therapies. These therapies are called CAR T-cell therapy and T-cell engaging antibodies.

The first step was to find out which issues might be important for patients treated with these new therapies. We did this by looking at information from articles and by conversations with clinicians, patients, and people from patient organisations. We also interviewed healthcare professionals from the participating countries. This helped us to create a list of 99 quality of life issues.

We also conducted interviews with patients to get a better understanding of what issues are important to them. They were also asked if there were any issues missing, if any issues were unnecessary, or if any issues should be worded differently. Right now, we are selecting the most important issues, and we will turn them into questionnaire items.

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