Development of a Short Instrument for Measuring Health-Related Quality of Life in Oncological Patients for Clinical Use: Protocol for an Observational Study (Preprint)

Author:

Schrage TheresaORCID,Görlach MirjaORCID,Betz Christian StephanORCID,Bokemeyer CarstenORCID,Kröger NicolausORCID,Mueller VolkmarORCID,Petersen CordulaORCID,Krüll AndreasORCID,Schulz HolgerORCID,Bleich ChristianeORCID

Abstract

BACKGROUND

Cancer patients often suffer from the physical and psychological burden of their disease and its treatment. This is frequently insufficiently identified and addressed in clinical practice. In the context of improving patient-centered care in oncological patients, patient-reported outcomes (PROs) represent an important addition to current routine care. So far, available PRO questionnaires for cancer patients are unsuitable for routine procedures due to their length and complexity.

OBJECTIVE

This study aimed to develop and psychometrically test a short questionnaire to measure health-related quality of life (HrQoL) in cancer patients for use in routine care.

METHODS

This observational study consists of two parts: (1) a qualitative study to develop a short questionnaire measuring HrQoL and (2) a quantitative study to psychometrically test this questionnaire in five oncological departments of a comprehensive cancer center. In part 1 of the study, semistructured interviews with 28 cancer patients, as well as five focus groups with 22 clinicians and nurses, were conducted to identify clinically relevant dimensions of HrQoL. The identified dimensions were complemented with related dimensions from empirical studies and reviewed via expert discussion. Based on this, a short instrument was developed. In part 2 of the study, the developed questionnaire was tested in cancer in- and outpatients at five participating oncological clinics using additional standardized questionnaires assessing HrQoL and other important PROs. The questionnaire was presented to more than 770 patients twice during treatment.

RESULTS

The project started in May 2017 with recruitment for study phase I beginning in December 2017. Recruitment for study phases I and II ended in April 2018 and February 2019, respectively. After study phase II and psychometrical analyses, the newly developed questionnaire measuring the HrQoL of all cancer entities in routine care was finalized.

CONCLUSIONS

With five to six dimensions and one item per dimension, the developed questionnaire is short enough to not disrupt routine procedures during treatment and is profound enough to inform clinicians about the patient’s HrQoL impairments and status.

CLINICALTRIAL

Open Science Framework Registries 10.17605/OSF.IO/Y7XCE; https://osf.io/y7xce/

INTERNATIONAL REGISTERED REPORT

RR1-10.2196/17854

Publisher

JMIR Publications Inc.

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