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The role of patient-reported outcomes in outpatients receiving active anti-cancer treatment: impact on patients’ quality of life

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Abstract

Introduction

Patient-reported outcomes (PROs) are the gold standard to describe subjective symptoms. Nurses can be successfully involved in collecting symptom information, because of their direct relationship with the patient. In order to improve clinical management of outpatients receiving active anti-cancer treatment, we introduced in routine clinical practice an assessment of patient-reported symptoms and toxicities, starting from January 2018. Our hypothesis was that this could help to better control symptoms, improving patients’ quality of life (QoL).

Methods

Eligible patients were receiving an active anti-cancer treatment, as outpatients. Patients included in the control group (treated in 2017) underwent “usual” visits (group A), while patients treated in 2018, before each visit received a questionnaire by a dedicated nurse, in order to provide information about symptoms and toxicities (group B). Primary objective was the comparison of QoL changes, measured by EORTC QLQ-C30.

Results

A total of 211 patients have been analyzed (119 group A; 92 group B). After 1 month, mean change from baseline of global QoL was − 1.68 in group A and + 2.54 in group B (p = 0.004, effect size 0.20). Group B showed significantly better mean changes for fatigue, pain, and appetite loss. Proportion of patients obtaining a clinically significant improvement in global QoL score was higher in group B (32.6%) compared to group A (19.3%, p = 0.04). Patients’ satisfaction with questionnaire was high.

Conclusion

Introduction of PROs in clinical practice, thanks to an active role of nurses, was feasible, produced high patients’ satisfaction and a significant QoL improvement, compared to the traditional modality of visit.

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References

  1. The National Cancer Institute (2006) Common terminology criteria for adverse events, version 3.0. [online], http://ctep.cancer.gov/protocolDevelopment/17electronic_applications/docs/ctcaev3.pdf

  2. Basch E, Bennett A, Pietanza MC (2011) Use of patient-reported outcomes to improve the predictive accuracy of clinician-reported adverse events. J Natl Cancer Inst 103:1808–1810

    Article  Google Scholar 

  3. Petersen MA, Larsen H, Pedersen L, Sonne N, Groenvold M (2006) Assessing health-related quality of life in palliative care: comparing patient and physician assessments. Eur J Cancer 42:1159–1166

    Article  Google Scholar 

  4. Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM (2004) 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 22:3485–183490

    Article  Google Scholar 

  5. Di Maio M, Basch E, Bryce J, Perrone F (2016) Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol 13(5):319–325

    Article  Google Scholar 

  6. U.S. Food and Drug Administration (2015) Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. [online], http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf

  7. European Medicines Agency (2005) Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. [online], http://www.ema.europa.eu/docs/19en_GB/document_library/Scientific_guideline/2009/09/WC500003637.pdf

    Google Scholar 

  8. Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D (2006) Patient versus clinician symptom reporting using the National Cancer Institute common terminology criteria for adverse events: results of a questionnaire based study. Lancet Oncol 7:903–909

    Article  Google Scholar 

  9. Grossman SA, Sheidler VR, Swedeen K, Mucenski J, Piantadosi S (1991) Correlation of patient and caregiver ratings of cancer pain. J Pain Symptom Manag 6:53–57

    Article  CAS  Google Scholar 

  10. Cirillo M, Venturini M, Ciccarelli L, Coati F, Bortolami O, Verlato G (2009) Clinician versus nurse symptom reporting using the National Cancer Institute-common terminology criteria for adverse events during chemotherapy: results of a comparison based on patient’s self-reported questionnaire. Ann Oncol 20:1929–1935

    Article  CAS  Google Scholar 

  11. Di Maio M, Gallo C, Leighl NB et al (2015) Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol 33:910–915

    Article  Google Scholar 

  12. Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D (2017) Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 318(2):197–198

    Article  Google Scholar 

  13. Judson TJ, Bennett AV, Rogak LJ, Sit L, Barz A, Kris MG, Hudis CA, Scher HI, Sabattini P, Schrag D, Basch E (2013) Feasibility of long-term patient self-reporting of toxicities from home via the internet during routine chemotherapy. J Clin Oncol 31(20):2580–2585

    Article  Google Scholar 

  14. Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D (2016) Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol 34(6):557–565

    Article  CAS  Google Scholar 

  15. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, Haes JCJM, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85(5):365–376

    Article  CAS  Google Scholar 

  16. Fayers P, Aaronson NK, Bjordal K et al (1999) on behalf of the EORTC Quality of Life Study Group EORTC QLQ-C30 Scoring Manual, 2nd edn. EORTC, Brussels (Belgium)

    Google Scholar 

  17. Osoba D, Rodrigues G, Myles J, Zee B, Pater J (1998) Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16(1):139–144

    Article  CAS  Google Scholar 

  18. Sperti E, Di Maio M (2017) Outcomes research: integrating PROs into the clinic - overall survival benefit or not, it's worth the trouble. Nat Rev Clin Oncol 14(9):529–530

    Article  Google Scholar 

  19. Howell D, Molloy S, Wilkinson K, Green E, Orchard K, Wang K, Liberty J (2015) Patient-reported outcomes in routine cancer clinical practice: a scoping review of use, impact on health outcomes, and implementation factors. Ann Oncol 26:1846–1858

    Article  CAS  Google Scholar 

  20. Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J (2008) The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res 17:179–193

    Article  CAS  Google Scholar 

  21. Chen J, Ou L, Hollis SJ (2013) A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Serv Res 13(211)

  22. Kotronoulas G, Kearney N, Maguire R, Harrow A, di Domenico D, Croy S, MacGillivray S (2014) What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol 32:1480–1501

    Article  Google Scholar 

  23. Stover AM, Basch EM (2016) Implementation of symptom questionnaires into oncology workflow. J Oncol Pract 12(10):859–862

    Article  Google Scholar 

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Acknowledgments

The authors wish to thank all the patients who were included in the analysis, and their caregivers.

Funding

Massimo Di Maio is recipient of a research funding from the CRT Foundation (Turin, Italy) for this project on the impact on quality of life of the systematic evaluation of toxicity with patient-reported outcomes in patients with solid cancer (CRT grant number 46333, “Richieste ordinarie 2015”). This research funding allowed the attendance of Chiara Baratelli, Carmela Giovanna Cleopatra Turco and Donatella Marino at Ordine Mauriziano Hospital.

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Author notes

  1. Chiara Baratelli

    Present address: Division of Medical Oncology, San Luigi Gonzaga Hospital, Orbassano, TO, Italy

Authors and Affiliations

  1. Division of Medical Oncology, Ordine Mauriziano Hospital, Turin, Italy

    Chiara Baratelli, Carmela Giovanna Cleopatra Turco, Gaetano Lacidogna, Elisa Sperti, Francesca Vignani, Donatella Marino, Clizia Zichi, Emmanuele De Luca, Marco Audisio, Daniela Ballaminut, Annalisa Bellezza, Paola Chiotto, Giovanna Ciriolo, Rossella Comite, Fulvia Codegone, Santina Florio, Luisa Fusco, Laura Polimeno, Donatella Pozzi, Eliana Zilio, Sabrina Terzolo & Massimo Di Maio

  2. Department of Oncology, University of Turin, Via Magellano 1, 10128, Turin, Italy

    Chiara Baratelli, Carmela Giovanna Cleopatra Turco, Donatella Marino, Clizia Zichi, Emmanuele De Luca, Marco Audisio & Massimo Di Maio

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Correspondence to Massimo Di Maio.

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We state that there are no conflict of interest do declare. We have full control of all primary data and we agree to allow the journal to review our data if requested.

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Equally contributing first authors Chiara Baratelli, Carmela Giovanna Cleopatra Turco

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Baratelli, C., Turco, C.G.C., Lacidogna, G. et al. The role of patient-reported outcomes in outpatients receiving active anti-cancer treatment: impact on patients’ quality of life. Support Care Cancer 27, 4697–4704 (2019). https://doi.org/10.1007/s00520-019-04777-2

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