Gender Neutral
Type Module
Testing Phase I / II - in development

Project summary

The EORTC recently started with 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 with relevant quality of life issues for patients treated with CAR T-cell therapy or T-cell engaging antibodies. We plan to complete phase I by March 2025.
Phase II includes the conversion of issues from the list into items. This will take about six months.

We are currently in Phase I, in which we compiled a comprehensive list of 94 issues that could be relevant to the target group. The list is based on literature, clinical expertise, discussion groups and conversations with patients and representatives from patient organisations. The list will be presented to healthcare professionals and patients during semi-structured interviews. Patients are asked to share their experience with CAR T-cell therapy or T-cell engaging antibodies. Patients and healthcare professionals will also be asked to review the issue list and score each issue on relevance and importance. Patients and healthcare professionals can also indicate which issues they miss, which issues are redundant and which issues they believe should be worded differently. The first interviews with healthcare professionals will start in September 2024 in the Netherlands and Germany.
In addition, we started with 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.

Achievements

The issue list is prepared and ready to be used for the upcoming interviews. Currently, we have received ethical approval for interviews with healthcare professionals and patients in the Netherlands and Germany.

The protocol for the systematic review is registered in PROSPERO. We screened all references that emerged from the search.

Current status:

We are currently in phase 1 of the module development. We are processing the results of the systematic literature review and we have started recruiting healthcare professionals for the interviews.

Future plans

We will soon start with the interviews in the Netherlands and Germany. After the United Kingdom, Australia, Croatia and Portugal receive ethical approval, they will also start the interviews.

Regarding the systematic literature review, we are currently extracting relevant data from the included studies.

For patients

We are 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 or T-cell engaging antibodies. The first step was to find out which issues could be important for patients treated with these new therapies. We figured this out by using information from literature, discussion groups and conversations with clinicians and representatives from patient organisations. This information helped us to make a list of important quality of life issues. The list will be presented to healthcare professionals and patients during interviews. They will be asked to score the issues. They will also be asked to indicate which issues they miss, which issues are unnecessary or which issues they believe should be worded differently. Once we have completed this, we will move on to the next step of developing the questionnaire. In which we will select issues and change them into items.

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