Reliability of an e-PRO Tool of EORTC QLQ-C30 for Measurement of Health-Related Quality of Life in Patients With Breast Cancer: Prospective Randomized Trial

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Abstract

Background

Breast cancer represents the most common malignant disease in women worldwide. As currently systematic palliative treatment only has a limited effect on survival rates, the concept of health-related quality of life (HRQoL) is gaining more and more importance in the therapy setting of metastatic breast cancer. One of the major patient-reported outcomes (PROs) for measuring HRQoL in patients with breast cancer is provided by the European Organization for Research and Treatment of Cancer (EORTC). Currently, paper-based surveys still predominate, as only a few reliable and validated electronic-based questionnaires are available. Facing the possibilities associated with evolving digitalization in medicine, validation of electronic versions of well-established PRO is essential in order to contribute to comprehensive and holistic oncological care and to ensure high quality in cancer research.

Objective

The aim of this study was to analyze the reliability of a tablet-based measuring application for EORTC QLQ-C30 in German language in patients with adjuvant and (curative) metastatic breast cancer.

Methods

Paper- and tablet-based questionnaires were completed by a total of 106 female patients with adjuvant and metastatic breast cancer recruited as part of the e-PROCOM study. All patients were required to complete the electronic- (e-PRO) and paper-based versions of the HRQoL EORTC QLQ-C30 questionnaire. A frequency analysis was performed to determine descriptive sociodemographic characteristics. Both dimensions of reliability (parallel forms reliability [Wilcoxon test] and test of internal consistency [Spearman rho and agreement rates for single items, Pearson correlation and Kendall tau for each scale]) were analyzed.

Results

High correlations were shown for both dimensions of reliability (parallel forms reliability and internal consistency) in the patient’s response behavior between paper- and electronic-based questionnaires. Regarding the test of parallel forms reliability, no significant differences were found in 27 of 30 single items and in 14 of 15 scales, whereas a statistically significant correlation in the test of consistency was found in all 30 single items and all 15 scales.

Conclusions

The evaluated e-PRO version of the EORTC QLQ-C30 is reliable for patients with both adjuvant and metastatic breast cancer, showing a high correlation in almost all questions (and in many scales). Thus, we conclude that the validated paper-based PRO assessment and the e-PRO tool are equally valid. However, the reliability should also be analyzed in other prospective trials to ensure that usability is reliable in all patient groups.

Trial Registration

ClinicalTrials.gov NCT03132506; https://clinicaltrials.gov/ct2/show/NCT03132506 (Archived by WebCite at http://www.webcitation.org/6tRcgQuou).

Related collections

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The umbrella term Patient Reported Outcomes (PRO) has been successfully proposed for instruments measuring perceived health outcomes, but its relationship to current conceptual models remains to be established. Our aim was to develop a classification system for PRO measures based on a valid conceptual model. We reviewed models and classification schemes of health outcomes and integrated them in a common conceptual framework, based on the models by Wilson and Cleary and the International Classification of Functioning (ICF). We developed a cross-classification system based on the minimum common set of consistent concepts identified in previous classifications, and specified categories based on the WHO International Classifications (ICD-10, and ICF). We exemplified the use of the classification system with selected PRO instruments. We identified three guiding concepts: (1) construct (the measurement object); (2) population (based on age, gender, condition, and culture); and (3) measurement model (dimensionality, metric, and adaptability). The application of the system to selected PRO measures demonstrated the feasibility of its use, and showed that most of them actually assess more than one construct. This classification system of PRO measures, based on a valid integrated conceptual model, should allow the classification of most currently used instruments and may facilitate a more adequate selection and application of these instruments.

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Among breast cancer patients who develop distant metastases, there is marked variability in the clinical course, including metastasis pattern. Here, we present a retrospective study of breast cancer patients who all developed distant metastases focusing on the association between breast cancer subtype and clinical course, including organ-specific metastasis. Tissue microarrays (TMAs) were assembled and stained for ER, PR, HER2, EGFR, CK5/6, CK14, E-Cadherin, TP53 and Ki67 for 263 breast cancer patients with metastatic disease. Tumours were classified into ER+/HER2−/Ki67high, ER+/HER2−/Ki67low, ER+/HER2+, ER−/HER2+ and ER−/HER2− groups. Relevant data related to metastasis pattern, metastasis timeline, systemic treatment and survival were retrieved. Associations between site-specific relapse and patient/tumour characteristics were assessed with multivariate models using logistic regression. Median time for development of distant metastasis was 30 months (range 0–15.3 years); 75.8 % of the distance metastases developed in the first 5 years after treatment of the primary tumour. Patients with ER−/HER2− tumours had a median overall survival of 27 months; those with HER2+ tumours of 52 months; those with ER+/HER2−/Ki67high of 76 months and those with ER+/HER2−/Ki67low of 79 months. Bone was the most common site for distant metastasis (70.6 %) followed by liver (54.5 %) and lung (31.4 %), respectively. Visceral metastasis was found in 76.8 % of the patients. Patients with ER−/HER2− tumours developed visceral metastases in 81 % and bone metastases in 55.2 %; those with HER2+ tumours developed visceral metastases in 77.4 % and bone metastases in 69.8 %; those with ER+/HER2−/Ki67high developed visceral metastases in 75.7 % and bone metastases in 87.8 % and those with ER+/HER2−/Ki67low developed visceral metastases in 76.9 % and bone metastases in 73.1 %. In metastatic breast cancer patients, tumour subtypes are associated with survival and pattern of distant metastases. These associations are of help in choices for surveillance and therapy in individual patients.

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John Speakman, Alexia Iasonos, Mary McCabe … (2007)

In cancer treatment trials, clinicians traditionally report patient toxicity symptoms. Alternatively, patients could provide this information directly. The Common Terminology Criteria for Adverse Events (CTCAE) is the mandated instrument for tracking patient toxicity symptoms in National Cancer Institute (NCI)-sponsored cancer treatment trials. We adapted CTCAE symptom items into patient language and uploaded these to an online platform. Lung cancer outpatients receiving chemotherapy were invited to self-report selected symptoms at visits via waiting area computers or optional home access. Symptom reports were printed for nurses at visits, but no instructions were given with regard to use of this information. From June 2005 through March 2006, 125 patients were invited to participate, and 107 chose to enroll. Mean length of participation was 42 weeks (range, 1 to 71 weeks), by which time 35% died. The average number of clinic visits was 12 (range, 1 to 40 visits). At each consecutive visit, most patients (mean, 78%) logged in without significant attrition. Reasons for failure to log in included having no reminder and having inadequate time. Although 76% of enrollees had home computers, only 15% self-reported from home. Satisfaction with the system was high (90%), but only 51% felt communication was improved. All participating nurses understood the reports and felt this information was useful for clinical decisions, documentation, and discussions. However, only one of seven nurses discussed reports with patients frequently, with insufficient time being the most common barrier to discussions. Online patient self-reporting is a feasible long-term strategy for toxicity symptom monitoring during chemotherapy, even among patients with advanced cancer and high symptom burdens. However, without explicit reminders and clinician feedback, patients demonstrated limited voluntary interest in self-reporting between visits.

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Author and article information

Contributors

Markus Wallwiener:

Gynecologic Oncology, National Center for Tumor Diseases, Hospital for General Obstetrics and GynecologyUniversity Hospital HeidelbergIm Neuenheimer Feld 440Heidelberg,Germany49 (0)6221563markus.wallwiener@gmail.com

ORCID: http://orcid.org/0000-0002-4139-9340

Journal

Journal ID (nlm-ta): J Med Internet Res

Journal ID (iso-abbrev): J. Med. Internet Res

Journal ID (publisher-id): JMIR

Title: Journal of Medical Internet Research

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Print): 1439-4456

ISSN (Electronic): 1438-8871

Publication date Collection: September 2017

Publication date (Electronic): 14 September 2017

Volume: 19

Issue: 9

Electronic Location Identifier: e322

Affiliations

[1] ¹ Gynecologic Oncology, National Center for Tumor Diseases, Hospital for General Obstetrics and Gynecology University Hospital Heidelberg Heidelberg Germany

[2] ² Research Institute for Women’s Health Department of Women’s Health University Hospital Tuebingen Tuebingen Germany

[3] ³ Department of Women’s Health University Hospital Tuebingen Tuebingen Germany

[4] ⁴ Institute for Medical Biometry and Informatics University Hospital Heidelberg Heidelberg Germany

[5] ⁵ Department of Gynecology and Obstetrics University Hospital Erlangen Erlangen Germany

Author notes

Corresponding Author: Markus Wallwiener markus.wallwiener@ 123456gmail.com

Author information

Markus Wallwiener http://orcid.org/0000-0002-4139-9340

Lina Matthies http://orcid.org/0000-0001-9754-0844

Elisabeth Simoes http://orcid.org/0000-0002-6149-6439

Lucia Keilmann http://orcid.org/0000-0002-0795-1680

Andreas D Hartkopf http://orcid.org/0000-0003-4831-2401

Alexander N Sokolov http://orcid.org/0000-0003-3691-8449

Christina B Walter http://orcid.org/0000-0002-3059-7595

Nina Sickenberger http://orcid.org/0000-0002-0083-182X

Stephanie Wallwiener http://orcid.org/0000-0003-2045-650X

Manuel Feisst http://orcid.org/0000-0002-5016-9731

Paul Gass http://orcid.org/0000-0002-4239-5528

Peter A Fasching http://orcid.org/0000-0003-4885-8471

Michael P Lux http://orcid.org/0000-0002-2781-2178

Diethelm Wallwiener http://orcid.org/0000-0002-4635-5283

Florin-Andrei Taran http://orcid.org/0000-0001-9167-047X

Joachim Rom http://orcid.org/0000-0002-9738-5503

Andreas Schneeweiss http://orcid.org/0000-0002-2429-4512

Joachim Graf http://orcid.org/0000-0003-2208-0446

Sara Y Brucker http://orcid.org/0000-0001-5162-1542

Article

Publisher ID: v19i9e322

DOI: 10.2196/jmir.8210

PMC ID: 5620457

PubMed ID: 28912116

SO-VID: 36157cb7-1479-4784-9c07-10024ca604e3

Copyright © ©Markus Wallwiener, Lina Matthies, Elisabeth Simoes, Lucia Keilmann, Andreas D Hartkopf, Alexander N Sokolov, Christina B Walter, Nina Sickenberger, Stephanie Wallwiener, Manuel Feisst, Paul Gass, Peter A Fasching, Michael P Lux, Diethelm Wallwiener, Florin-Andrei Taran, Joachim Rom, Andreas Schneeweiss, Joachim Graf, Sara Y Brucker. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 14.09.2017.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

History

Date received : 28 June 2017

Date revision requested : 13 July 2017

Date revision received : 8 August 2017

Date accepted : 14 August 2017

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