Multicenter, open-label, randomized, controlled study to test the utility of electronic patient-reported outcome monitoring in patients with unresectable advanced cancers or metastatic/recurrent solid tumors
Electronic patient-reported outcome (ePRO) monitoring for patients undergoing cancer chemotherapy may provide qualified and early detection of adverse events or disease-related symptoms, leading to improved patient care. The aim of this study is to examine whether addition of ePRO monitoring to routine medical care contributes to improved overall survival and quality of life of cancer patients undergoing chemotherapy. Patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic chemotherapy will be randomized to an ePRO monitoring group and a usual care group. The ePRO group will conduct weekly symptom monitoring using an electronic device after study enrollment until the end of the study. Monitoring results will be returned to medical personnel and used as information for patient care. The primary endpoints are overall survival and health related quality of life. The initial target sample size for the study was 1500 patients. However, due to delays in enrollment, the target was readjusted to 500 patients. Enrollment has been completed, and the study is now in the follow-up phase.
Authors
- Takeru Shiroiwa (ORCID: https://orcid.org/0000-0003-3055-9932)
- Hiroji Iwata (ORCID: https://orcid.org/0000-0002-0242-4718)
- Ryosuke Tateishi (ORCID: https://orcid.org/0000-0003-3021-2517)
- Akihiko Gemma (ORCID: https://orcid.org/0000-0003-0762-2737)
- Yasuhiro Hagiwara (ORCID: https://orcid.org/0000-0003-3792-5368)
- Yukiya Narita (ORCID: https://orcid.org/0000-0002-8018-0077)
- Naomi Kiyota (ORCID: https://orcid.org/0000-0001-8021-6116)
- Takashi Fukuda (ORCID: https://orcid.org/0000-0001-9599-6274)
- Akinobu Nakata (ORCID: https://orcid.org/0000-0002-5599-3906)
- Eiki Ichihara (ORCID: https://orcid.org/0000-0002-2966-106X)
- Kojiro Shimozuma
- Katsuyuki Hotta (ORCID: https://orcid.org/0000-0002-0112-0843)
- Naruto Taira (ORCID: https://orcid.org/0000-0003-4266-1117)
- Yuichiro Kikawa (ORCID: https://orcid.org/0000-0002-3852-5991)
- Tetsuya Iwamoto
- Takuhiro Yamaguchi (ORCID: https://orcid.org/0000-0002-7961-9417)
- Kei Muro (ORCID: https://orcid.org/0000-0002-5572-743X)
- Keiichiro Nakamura (ORCID: https://orcid.org/0000-0002-4609-5258)
- Yuki Takumoto (ORCID: https://orcid.org/0000-0001-9191-3494)
- Hironobu Minami (ORCID: https://orcid.org/0000-0001-8630-9145)
- Kaoru Kubota (ORCID: https://orcid.org/0000-0003-0367-2606)
- Kyoko Kato
Institutions
- Kansai Medical University (JP)
- Ritsumeikan University (JP)
- Okayama University (JP)
- Kawasaki Medical School (JP)
- Tohoku University (JP)
- Osaka City University (JP)
- Nagoya City University (JP)
- National Institute of Public Health (JP)
- Kobe University Hospital (JP)
- Okayama University Hospital (JP)
- National Hospital Organization (JP)
- Nagoya Medical Center (JP)
- Mizuho (Japan) (JP)
- Kobe University (JP)
- The University of Tokyo (JP)
- Nippon Medical School (JP)
Publication Details
- Journal
- Japanese Journal of Clinical Oncology
- Published
- 2025-02-23
- DOI
- https://doi.org/10.1093/jjco/hyaf033
- Citations
- 2
- Primary Topic
- Cancer survivorship and care
- Type
- article
- Field-Weighted Citation Impact
- 2.09
Funders
- Pitt Hopkins Research Foundation