PMID- 37495393 OWN - NLM STAT- MEDLINE DCOM- 20230728 LR - 20230729 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 13 IP - 7 DP - 2023 Jul 26 TI - Electronic patient-reported outcome (e-PRO) monitoring for adverse event management during cabozantinib treatment in patients with advanced renal cell carcinoma: protocol for a three-arm, randomised, multicentre phase II trial (e-PRO vs paper-PRO or usual care). PG - e070275 LID - 10.1136/bmjopen-2022-070275 [doi] LID - e070275 AB - INTRODUCTION: Cabozantinib monotherapy is an option for treatment of advanced renal cell carcinoma (RCC). However, cabozantinib dose modification and discontinuation due to symptomatic adverse events (AEs) remains a challenge. The use of patient-reported outcomes (PROs) may help manage symptomatic AEs, which is reported to lead to improved quality of life (QOL), avoidance of drug discontinuation and better survival. This study aims to investigate the clinical benefits of PROs in patients with RCC receiving cabozantinib and the most appropriate medium for PRO monitoring (electronic [e]-PRO or paper-PRO). METHODS AND ANALYSIS: This study is being conducted at about 35 sites in Japan. Patients aged >/=18 years with unresectable or metastatic RCC initiating treatment with cabozantinib monotherapy are eligible and will be randomised to: (1) e-PRO monitoring, (2) paper-PRO monitoring or (3) usual care without PRO monitoring. Recruitment began in December 2021 (target sample size, 105). Patients start treatment with cabozantinib 60 mg once daily, and in the PRO groups, will record daily medication intake, weight, temperature, blood pressure and AEs. Endpoints include the proportion of patients with a >/=5-point deterioration on the Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI-19; primary endpoint), progression-free survival, QOL, dose adjustments, relative dose intensity, treatment-emergent AEs and frequency of interventions for AEs outside of the scheduled visits. Patient and physician opinions of the PRO monitoring systems and patient compliance with e-PRO/paper-PRO input are also being measured. ETHICS AND DISSEMINATION: The study is being conducted in compliance with the Declaration of Helsinki, the International Council for Harmonisation guidelines for Good Clinical Practice and the Clinical Trials Act. Written informed consent is being obtained from all patients, and the protocol has been approved by the Hokkaido University Hospital Certified Review Board (approval number, CRB021-005). The results will be presented at conferences and submitted to a peer-reviewed journal. TRIAL REGISTRATION NUMBER: jRCTs011210055. CI - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Osawa, Takahiro AU - Osawa T AD - Department of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan. FAU - Fujii, Yasuhisa AU - Fujii Y AD - Department of Urology, Tokyo Medical and Dental University, Tokyo, Japan. FAU - Kimura, Go AU - Kimura G AD - Department of Urology, Nippon Medical School, Tokyo, Japan. FAU - Kitamura, Hiroshi AU - Kitamura H AD - Department of Urology, Faculty of Medicine, University of Toyama, Toyama, Japan. FAU - Nagashima, Yoji AU - Nagashima Y AD - Department of Surgical Pathology, Tokyo Women's Medical University, Tokyo, Japan. FAU - Iizumi, Sakura AU - Iizumi S AD - Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, Tokyo, Japan. FAU - Osaka, Tsuyoshi AU - Osaka T AD - Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, Tokyo, Japan. FAU - Tsubouchi, Ryoichi AU - Tsubouchi R AD - Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, Tokyo, Japan. FAU - Shinohara, Nobuo AU - Shinohara N AUID- ORCID: 0000-0002-6695-294X AD - Department of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan nozomis@mbj.nifty.com. LA - eng PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230726 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 1C39JW444G (cabozantinib) SB - IM MH - Humans MH - Adolescent MH - Adult MH - *Carcinoma, Renal Cell/drug therapy MH - Quality of Life MH - *Kidney Neoplasms/drug therapy/pathology MH - Patient Reported Outcome Measures MH - Treatment Outcome MH - Randomized Controlled Trials as Topic MH - Multicenter Studies as Topic MH - Clinical Trials, Phase II as Topic PMC - PMC10373669 OTO - NOTNLM OT - Adverse events OT - Clinical trials OT - Kidney tumours OT - Urological tumours COIS- Competing interests: TOsak, RT and SI are employees of Takeda. TOsaw and YN have no conflicts of interest to declare. YF has received honoraria from Astellas Pharma, AstraZeneca, Bayer, Janssen, Kissei, Merck, MSD, Myriad, Nippon Shinyaku, Ono, Pfizer, Sanofi and Takeda; has undertaken consulting or advisory services for Astellas Pharma, AstraZeneca, Eisai and Merck; and has received research funding from Astellas Pharma, Ono and Takeda. GK has received honoraria from Bristol Myers Squibb Japan, Ono Yakuhin and Chugai Pharma; has undertaken consulting or advisory services for Eisai; and has been a speaker for Bristol Myers Squibb Japan, Ono Yakuhin, MSD, Chugai Pharma, Bayer Yakuhin, Janssen, Merck Biopharma, Sanofi and Takeda. HK has received honoraria from Astellas Pharma, AstraZeneca/Daiichi Sankyo, MSD, Bayer Yakuhin, Takeda, Merck/Pfizer, Sanofi, Janssen, Bristol Myers Squibb Japan, Nippon Kayaku, Nippon Shinyaku and Chugai Pharma; has undertaken consulting or advisory services for Astellas Pharma, AstraZeneca/Daiichi Sankyo, MSD, Janssen, Pfizer, Takeda, Chugai Pharma, Eisai and Kissei Pharmaceutical; and has received research funding from Takeda, Bayer Yakuhin, Sanofi, Astellas Pharma, MSD and AstraZeneca/Daiichi Sankyo. NS has been a speaker for Pfizer, Ono, Takeda, MSD and AstraZeneca; and has received research funding from Ono, Takeda and Astellas Pharma. EDAT- 2023/07/27 01:09 MHDA- 2023/07/28 06:42 PMCR- 2023/07/26 CRDT- 2023/07/26 21:23 PHST- 2023/07/28 06:42 [medline] PHST- 2023/07/27 01:09 [pubmed] PHST- 2023/07/26 21:23 [entrez] PHST- 2023/07/26 00:00 [pmc-release] AID - bmjopen-2022-070275 [pii] AID - 10.1136/bmjopen-2022-070275 [doi] PST - epublish SO - BMJ Open. 2023 Jul 26;13(7):e070275. doi: 10.1136/bmjopen-2022-070275.