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Clinical effects of assessing electronic patient-reported outcomes monitoring symptomatic toxicities during breast cancer therapy: a nationwide and population-based study

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Abstract

The involvement of cancer patients in symptom reporting talks into our cultural narrative of empowerment and participation in decisions in health of both patients and professionals. Electronic patient-reported outcome (ePRO) is a tool applied for use in such interaction. Based on limited evidence and few empirical studies, health systems are rapidly implementing this instrument in managing patients in active treatment and in follow-up. In a cluster randomized trial of all Danish oncology departments treating breast cancer with adjuvant chemotherapy, we applied ePRO in 347 patients consecutively recruited. Our primary outcome, which was at least one treatment adjustment, was not significantly influenced using ePRO, 34% in the ePRO arm and 41% in the usual care arm received at least one treatment adjustment, p = 0.095. Number of hospitalizations and events of febrile neutropenia were not influenced by the intervention. We believe that one of the main reasons for this finding could be the application of PRO in a well-regulated treatment setting within a public health care system where the most impacting symptomatic toxicities are already taken care off.

Trial registration: Clinicaltrials.gov identifier: NCT02996201, registered 19 Dec 2016, retrospectively registered.

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Data availability

The dataset used during the current study is available from the corresponding author on reasonable request.

Abbreviations

PRO:

Patient-reported outcome

ePRO:

Electronic patient-reported outcome

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Acknowledgements

The authors wish to thank all breast cancer patients who took part in this study.

Funding

This study was funded by the Danish Cancer Society (R113-A7084-14-S34).

Author information

Authors and Affiliations

  1. Documentation and Quality, Danish Cancer Society, Strandboulevarden 49, DK 2100, Copenhagen, Denmark

    Helle Pappot, Christina W. Baeksted, Aase Nissen & Jane Christensen

  2. Department of Oncology, Rigshospitalet, Blegdamsvej 9, DK 2100, Copenhagen, Denmark

    Helle Pappot, Christina W. Baeksted, Ann Knoop & Christoffer Johansen

  3. Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Drive, 3 East Suite 448, Rockville, MD, 20850, USA

    Sandra A. Mitchell

  4. Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45, 8200, Aarhus, Denmark

    Niels Henrik Hjollund

  5. West Chronic, Department of Occupational Medicine, University Clinic, Health, Aarhus University, Gl. Landevej 61, 7400, Herning, Denmark

    Niels Henrik Hjollund

  6. Unit of Survivorship, Danish Cancer Society Research Center, Strandboulevarden 49, DK 2100, Copenhagen, Denmark

    Christoffer Johansen

Authors
  1. Helle Pappot
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  2. Christina W. Baeksted
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  3. Aase Nissen
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  4. Ann Knoop
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  5. Sandra A. Mitchell
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  6. Jane Christensen
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  7. Niels Henrik Hjollund
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  8. Christoffer Johansen
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Contributions

HP, CWB, AaN and CJ designed the study and planned the implementation with AK. NHH designed the software. HP and CWB performed the study. CWB and JC performed the statistical analysis. All authors were actively involved in interpreting the results and writing the manuscript.

Corresponding author

Correspondence to Helle Pappot.

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Conflict of interest

The authors declare no competing interests in relation to the present publication.

Ethical approval

Ethics approval for the present study was not needed due to Danish law. The study was approved by the Danish Data Protection Agency (File number, 2015-41-4190) and registered at Clinicaltrials.gov (Clinicaltrials.gov identifier NCT02996201).

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All participants included completed informed consent.

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Pappot, H., Baeksted, C.W., Nissen, A. et al. Clinical effects of assessing electronic patient-reported outcomes monitoring symptomatic toxicities during breast cancer therapy: a nationwide and population-based study. Breast Cancer 28, 1096–1099 (2021). https://doi.org/10.1007/s12282-021-01244-x

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  • DOI: https://doi.org/10.1007/s12282-021-01244-x

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