Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

Abstract

Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer.

Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ-5D-5L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed.

Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff.

Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patients’ compliance was better with some questionnaires, butothers may present difficulties.

Zusammenfassung

Hintergrund Das PRAEGNANT-Netzwerk ist ein prospektives translationales Forschungskonzept zur Optimierung der gesundheitlichen Versorgung von Patientinnen mit lokal fortgeschrittenem oder metastastiertem Brustkrebs. Patient-reported outcomes (PROs) wurden in vielen klinischen Studien aufgenommen. Zunehmend geht es von der analogen Erhebung auf Papier (pPRO) in die elektronische Erhebung (ePRO) über. Dieses Subprotokoll der PRAEGNANT soll die Implementierung und Machbarkeit dieses neuen Vorgehens evaluieren.

Methoden Die Patientinnen wurden von dem Personal der Studienzentrale, dem ärztlichen oder dem pflegerischen Personal am Brustzentrum Franken des Universitätsklinikums Erlangen, gebeten, 3 standardisierte Fragebögen zum PROs (EQ-5D-5L, CES-D und IPAQ) elektronisch auszufüllen. Anschließend wurde die Bedienbarkeit und Zufriedenheit der Patientinnen und die Benutzerfreundlichkeit zur Vergabe der Zugangsdaten von den 3 Personalgruppen abgefragt.

Ergebnisse Fünfzehn von 17 eingeschlossenen Patientinnen füllten abschließend die 2 ePRO-Fragebögen (EQ-5D-5L und CES-D) aus. Der elektronische Fragebogen zur körperlichen Aktivität (IPAQ) konnte von 9 der 15 Patientinnen erhoben werden. Machbarkeit zur Benutzerdatenvergabe wurde absteigend von den Ärzten gegenüber dem Studienzentralenpersonal und Pflegepersonal als besser bewertet.

Schlussfolgerung Die Benutzung der ePRO-Fragebögen ist in der PRAEGNANT Registry grundsätzlich durchführbar. Die Machbarkeit hängt maßgeblich von den Fähigkeiten und Kapazitäten der beteiligten Patientinnen und Personalgruppen ab. Die Compliance und Vollständigkeit war nicht bei allen ePRO-Fragebögen gleich gut und ergab teilweise Schwierigkeiten.

Key words

breast cancer - patient-reported outcomes - electronic data capture - compliance - quality of life

Schlüsselwörter

Brustkrebs - Patient-reported Outcomes - Electronic Data Capture - Compliance - Lebensqualität

^* Shared first authorship.

• References

• 1 Cardoso F, van’t Veer LJ, Bogaerts J. et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med 2016; 375: 717-729
• 2 Sparano JA, Gray RJ, Makower DF. et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med 2015; 373: 2005-2014
• 3 Schneeweiss A, Ruckhaberle E, Huober J. Chemotherapy for metastatic breast cancer – an anachronism in the era of personalised and targeted oncological therapy?. Geburtsh Frauenheilk 2015; 75: 574-583
• 4 Baselga J, Campone M, Piccart M. et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 2012; 366: 520-529
• 5 Bendell JC, Rodon J, Burris HA. et al. Phase I, dose-escalation study of BKM120, an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. J Clin Oncol 2012; 30: 282-290
• 6 Dieterich M, Angres J, Stubert J. et al. Patient-reported outcomes in implant-based breast reconstruction alone or in combination with a titanium-coated polypropylene mesh – a detailed analysis of the BREAST-Q and overview of the literature. Geburtsh Frauenheilk 2015; 75: 692-701
• 7 Siedentopf F, Utz-Billing I, Gairing S. et al. Yoga for patients with early breast cancer and its impact on quality of life – a randomized controlled trial. Geburtsh Frauenheilk 2013; 73: 311-317
• 8 Reilly CM, Bruner DW, Mitchell SA. et al. A literature synthesis of symptom prevalence and severity in persons receiving active cancer treatment. Support Care Cancer 2013; 21: 1525-1550
• 9 Fromme EK, Eilers KM, Mori M. et al. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol 2004; 22: 3485-3490
• 10 Lux MP, Maass N, Schuetz F. et al. Breast cancer 2013 – interpretation of new and known data. Geburtsh Frauenheilk 2013; 73: 584-598
• 11 Basch E. Patient-reported outcomes in drug safety evaluation. Ann Oncol 2009; 20: 1905-1906
• 12 Basch E, Jia X, Heller G. et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst 2009; 101: 1624-1632
• 13 U. S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U. S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U. S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006; 4: 79
• 14 Wuerstlein R, Kirkovits T, Drewes C. et al. eHealth in modern breast cancer treatment: new possibilities in communication between patients, doctors and nursing staff. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9–13. 75. San Antonio, TX Philadelphia (PA): AACR. Cancer Res; 2015. (9 Suppl.): Abstract nr P2–10–05
• 15 Willke RJ, Burke LB, Erickson P. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Control Clin Trials 2004; 25: 535-552
• 16 Szende A, Leidy NK, Revicki D. Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorizations of medicinal products 1995 to 2003. Value Health 2005; 8: 534-548
• 17 Abernethy AP, Herndon 2nd JE, Wheeler JL. et al. Feasibility and acceptability to patients of a longitudinal system for evaluating cancer-related symptoms and quality of life: pilot study of an e/Tablet data-collection system in academic oncology. J Pain Symptom Manage 2009; 37: 1027-1038
• 18 Basch E. New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment. Annu Rev Med 2014; 65: 307-317
• 19 Dueck AC, Mendoza TR, Mitchell SA. et al. Validity and reliability of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol 2015; 1: 1051-1059
• 20 Basch E, Iasonos A, Barz A. et al. Long-term toxicity monitoring via electronic patient-reported outcomes in patients receiving chemotherapy. J Clin Oncol 2007; 25: 5374-5380
• 21 Judson TJ, Bennett AV, Rogak LJ. et al. Feasibility of long-term patient selfreporting of toxicities from home via the Internet during routine chemotherapy. J Clin Oncol 2013; 31: 2580-2585
• 22 Graf J, Simoes E, Wisslicen K. et al. Willingness of patients with breast cancer in the adjuvant and metastatic setting to use electronic surveys (ePRO) depends on sociodemographic factors, health-related quality of life, disease status and computer skills. Geburtsh Frauenheilk 2016; 76: 535-541
• 23 Di Maio M, Basch E, Bryce J. et al. Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol 2016; 13: 319-325
• 24 Fasching PA, Brucker SY, Fehm TN. et al. Biomarkers in patients with metastatic breast cancer and the PRAEGNANT Study Network. Geburtsh Frauenheilk 2015; 75: 41-50
• 25 Hein A, Gass P, Walter CB. et al. Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for metastatic breast cancer patients. Breast Cancer Res Treat 2016; 158: 59-65
• 26 The IPAQ group at Karolinska Institute Stockholm. Guidelines for data processing and analysis of the International Physical Activity Questionnaire (IPAQ). 2005 Online: https://sites.google.com/site/theipaq/scoring-protocol last access: 01.09.2016
• 27 Axen I, Bodin L, Bergstrom G. et al. The use of weekly text messaging over 6 months was a feasible method for monitoring the clinical course of low back pain in patients seeking chiropractic care. J Clin Epidemiol 2012; 65: 454-461
• 28 Registered Nurses’ Association of Ontario (RNAO). The Nursing and eHealth Project. Online: http://rnao.ca/ehealth last access: 16.09.2016
• 29 e-Health Nurses Network. Online: http://www.ehealthnurses.org.uk/ last access: 16.09.2016
• 30 International Council of Nurses (ICN). eHealth Programme encompasses. Online: http://www.icn.ch/what-we-do/ehealth/ last access: 16.09.2016
• 31 Schaffeler N, Pfeiffer K, Grischke EM. et al. Acceptance and reliability of an electronic psychooncological screening of patients with breast cancer: a randomized controlled study. Psychotherapie, Psychosomatik, medizinische Psychologie 2013; 63: 374-380
• 32 Coons SJ, Gwaltney CJ, Hays RD. et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health 2009; 12: 419-429
• 33 Jehn CF, Flath B, Strux A. et al. Influence of age, performance status, cancer activity, and IL-6 on anxiety and depression in patients with metastatic breast cancer. Breast Cancer Res Treat 2012; 136: 789-794
• 34 Li D, Zhang DJ, Shao JJ. et al. A meta-analysis of the prevalence of depressive symptoms in Chinese older adults. Arch Gerontol Geriatr 2014; 58: 1-9
• 35 Fernandez-Alonso L, Munoz-Garcia D, La ToucheR. The level of physical activity affects the health of older adults despite being active. J Exerc Rehabil 2016; 12: 194-201
• 36 Wanner M, Martin BW, Autenrieth CS. et al. Associations between domains of physical activity, sitting time, and different measures of overweight and obesity. Preventive Medicine Reports 2016; 3: 177-184
• 37 Dabrowska J, Dabrowska-Galas M, Naworska B. et al. The role of physical activity in preventing obesity in midlife women. Prz Menopauzalny 2015; 14: 13-19
• 38 Ruiz-Casado A, Alejo LB, Santos-Lozano A. et al. Validity of the Physical Activity Questionnaires IPAQ-SF and GPAQ for cancer survivors: insights from a Spanish cohort. Int J Sports Med 2016; DOI: 10.1055/s-0042–103967.
• 39 Hurtig-Wennlof A, Hagstromer M, Olsson LA. The International Physical Activity Questionnaire modified for the elderly: aspects of validity and feasibility. Public Health Nutr 2010; 13: 1847-1854
• 40 Forsen L, Loland NW, Vuillemin A. et al. Self-administered physical activity questionnaires for the elderly: a systematic review of measurement properties. Sports Med 2010; 40: 601-623