Development of an EORTC patient-reported outcome measure (questionnaire module) for renal cell cancer patients (provisional RCC-38): Phase III

Development of an EORTC patient-reported outcome measure (questionnaire module) for renal cell cancer patients (provisional RCC-38): Phase III

The EORTC Quality of Life Group (QLG) is developing a questionnaire to better assess the quality of life (QOL) in kidney cancer patients. This questionnaire focuses on the specific challenges faced by kidney cancer patients. This questionnaire once fully developed will be given to kidney cancer patients along with the existing EORTC QLQ-C30 questionnaire. The questionnaire will be given to the kidney cancer patients to get their opinion whether the questions in the questionnaire are relevant and important for the kidney cancer patients or not. In addition, these patients will also inform whether there are any questions which are relevant bur not present in the developing questionnaire or not. A diverse group of RCC patients at different stages and treatments will participate to ensure the questionnaire reflects a wide range of experiences. Responses provided by the patient will be to the study sponsor in an anonymized form.

The study will be conducted in two phases:

Phase IIIa: Identifies unclear or unnecessary questions and ensures all relevant issues are addressed.

Phase IIIb: Tests the reliability of the questionnaire to measure QOL accurately.

In this regard, patients who are enrolled in this study, will complete the QLQ-C30, QLQ-RCC38, and WISP (Write-in-three-Symptoms/Problems) forms.

Objectives

The specific aims of phase III are divided in two parts, reflecting a stepwise approach:

Phase IIIa

1. Identifying and resolving any administration problems (e.g., related to the wording of the items or the order of the items).

2. Investigating the comprehensiveness of included issues/items (e.g., check for missing or redundant issues/items).

Phase IIIb

3. Performing a preliminary evaluation of the psychometric properties of the provisional module.

 Inclusion criteria

The overall inclusion criteria are the following:

1. Diagnosis of renal cell cancer (irrespective of treatment or follow up status)

2. 18 years of age or above

3. Indication of biological sex as male or female

4. No concurrent malignancies (should there be problems recruiting patients, this criterion could be made less strict and other cancers would be authorised, as long as they are in remission/not being treated)

5. No cognitive impairment

6. Fluency in the resident language of the collaborator (to complete the questionnaires and participate in the interview)

7. Written informed consent

 Further inclusion criteria are applied depending on the recruitment matrix cell for which a patient is to be assessed:

1. Disease stage

2. Current treatment

3. Sex-ratio of 2:1 (male:female)

The revised questionnaire will help researchers and doctors better understand RCC patients’ needs, enabling personalized care and improved QOL. The finalized tool will undergo further validation in Phase IV.

Methods

Patients will complete a single assessment. For both Phase IIIa and IIIb, patients will receive the EORTC QLQ-C30, the QLQ-RCC38 module and the Write-in-three-Symptoms/Problems (WISP) addendum for completion. In Phase IIIa, questionnaire completion is followed by a more detailed debriefing interview. In Phase IIIb, patients complete a one-page debriefing sheet. Details on the debriefing interview and debriefing sheet can be found further below.

As Phase III of the QLQ-RCC38 includes the translation of the WISP addendum into Hindi, Marathi, Hebrew and Greek, the data assessment also includes the pre-test of the WISP translations. The process will be streamlined with the Phase IIIa debriefing interview and will be conducted for the first approximately 5 patients in each language. If patients request changes to the translations, additional patients will be interviewed about the appropriateness of the adapted WISP translation (expected to be a maximum of 10 patients in total for the translation pre-test).

Informed consent is obtained from each patient before the start of the data collection/interview. In Phase IIIa, the interviewer will take notes during the interview. In Phase IIIb, patients will be asked to complete all documentation themselves where possible. All patient data will be anonymised by using only the study number or initials, and the identity will only be disclosed to the interviewers and the local organiser.

 Main Output

The Phase III will result in a pre-tested version of the EORTC QLQ-RCC38 and a tentative scoring system. An interim report on the results on Phase IIIa and their implications on the module and Phase IIIb will be produced. A publication on the development process (summary of Phases I-II and IIIa/b) will serve as the final project report. At the end of Phase IIIb, the EORTC QLQ-RCC38 will be ready for international validation.

 Timetable and milestones

The overall project duration for phase III is estimated at 36 months once started.