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Pilot trial of an electronic patient-reported outcome monitoring system in patients with metastatic breast cancer undergoing chemotherapy

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Abstract

Background

Electronic patient-reported outcomes monitoring (ePROM) is a useful communication tool for patients and healthcare providers in cancer chemotherapy. In this study, we examined the feasibility of our newly developed ePROM system, which we refer to as “Hibilog”.

Methods

An ePROM app was developed by extracting 18 items from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE). Symptom monitoring was conducted every two weeks for patients with metastatic breast cancer undergoing chemotherapy. The primary outcome was the response rate to the ePROM system. The secondary outcomes were response time, item missing rate, and distribution of responses for each symptom.

Results

A total of 71 cases (mean age 52.6 years) were analyzed. Performance status was 0 in 76% of the cases and 1 or higher in 24%. First-line treatment was being administered in 30% of cases, second-line treatment in 17%, and third-line or higher treatment in 53%. The response rate to the ePROM system from registration to week 40 remained high at around 80%, indicating good compliance. The average response time was 5.5 min and the missing rate for each item was below 0.4%. Among 1,093 responses, the top 3 symptoms causing interference with daily life were Fatigue (63%), Numbness and tingling (48%), and General pain (46%).

Conclusion

Our developed ePROM system was able to capture symptoms accurately in patients with metastatic breast cancer undergoing chemotherapy while maintaining a high response compliance.

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Data availability

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We are grateful to Mr. Ohshita and Mr. Inagaki for their important contributions to development of the app.

Funding

This study was supported by the Japanese Breast Cancer Society: "Exploring the Utilization of Appropriate Patient Reported Outcomes in Breast Cancer Practice."

Author information

Authors and Affiliations

  1. Department of Breast and Thyroid Surgery, Kawasaki Medical School, 577 Matsushima, Kurashiki City, Okayama, 701-0192, Japan

    Naruto Taira & Takayuki Iwamoto

  2. Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan

    Naruto Taira, Takayuki Iwamoto, Hiroyoshi Doihara & Tadahiko Shien

  3. Department of Breast Surgery, Kansai Medical University Hospital, Osaka, Japan

    Yuichiro Kikawa

  4. Department of Breast and Endocrine Surgery, Kagawa Prefectural Central Hospital, Takamatsu, Japan

    Yuichiro Miyoshi

  5. Department of Breast and Endocrine Surgery, Japanese Red Cross Okayama Hospital, Okayama, Japan

    Kyoko Hara & Seiji Yoshitomi

  6. Department of Breast Surgery, Japanese Red Cross Matsue Hospital, Matsue, Japan

    Hajime Hikino

  7. Department of Breast and Endocrine Surgery, National Hospital Organization Fukuyama Medical Centre, Fukuyama, Japan

    Hirotoshi Takahashi

  8. Department of Breast Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan

    Daisuke Takabatake

  9. Department of Breast and Thyroid Surgery, Fukuyama City Hospital, Fukuyama, Japan

    Shinichiro Kubo & Masahiko Ikeda

  10. Department of Surgery, Kawasaki Medical School General Medical Center, Okayama, Japan

    Hiroyoshi Doihara

  11. Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan

    Hiromi Okuyama

  12. Department of Clinical Oncology, Toranomon Hospital, Tokyo, Japan

    Yuko Tanabe

  13. Department of Breast Medical Oncology, Japanese Foundation for Cancer Research Cancer Institute Hospital, Tokyo, Japan

    Fumikata Hara

  14. Department of Breast and Endocrine Surgery, Nagasaki Harbor Medical Center, Nagasaki, Japan

    Kosho Yamanouchi

  15. Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan

    Yasuhiro Hagiwara

  16. Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan

    Masataka Sawaki

Authors
  1. Naruto Taira
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  2. Yuichiro Kikawa
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  3. Takayuki Iwamoto
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  4. Yuichiro Miyoshi
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  5. Kyoko Hara
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  6. Seiji Yoshitomi
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  7. Hajime Hikino
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  8. Hirotoshi Takahashi
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  9. Daisuke Takabatake
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  10. Shinichiro Kubo
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  11. Masahiko Ikeda
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  12. Hiroyoshi Doihara
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  13. Tadahiko Shien
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  14. Hiromi Okuyama
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  15. Yuko Tanabe
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  16. Fumikata Hara
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  17. Kosho Yamanouchi
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  18. Yasuhiro Hagiwara
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  19. Masataka Sawaki
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Contributions

NT and YK contributed to the study design. NT, TI, YM, KH, SY, HH, HT, DT, SK, MI, HD and TS contributed to material preparation, data collection, and analysis. NT wrote the first draft of the manuscript. All authors commented on versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Naruto Taira.

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Conflict of interest

There are no conflicts of interest regarding the implementation of this research.

Ethical approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Okayama University Hospital (Date 2019.8.30/No. 1907-033).

Consent to participate

Written informed consent was obtained from all participants in the study.

Consent to publish

The authors affirm that all patients provided informed consent for publication of all figures and tables.

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Taira, N., Kikawa, Y., Iwamoto, T. et al. Pilot trial of an electronic patient-reported outcome monitoring system in patients with metastatic breast cancer undergoing chemotherapy. Breast Cancer 31, 283–294 (2024). https://doi.org/10.1007/s12282-023-01537-3

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  • DOI: https://doi.org/10.1007/s12282-023-01537-3

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