Yukari Tsubata1, Shun Shinomiya2, Koji Inoue3, Nobuhisa Ishikawa4, Ryota Saito5, Kazuhisa Nakashima6, Katsuyuki Hotta7, Akinobu Hamada8, Fumio Nagashima9, Yuichi Ando10, Satoshi Morita11, Kunihiko Kobayashi2, Takeshi Isobe6. 1. Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, 89-1 Enya-cho, 693-8501, Izumo, Shimane, Japan. ytsubata@med.shimane-u.ac.jp. 2. Department of Respiratory Medicine, Saitama Medical University International Medical Center, 397-1 Yamane, 350-1298, Hidaka, Saitama, Japan. 3. Department of Respiratory Medicine, Ehime Prefectural Central Hospital, 83 Kasuga-cho, 790-0024, Matsuyama, Ehime, Japan. 4. Department of Respiratory Medicine, Hiroshima Prefectural Hospital, 1-5-54 Ujinakanda, Minami-ku, 734-8530, Hiroshima, Japan. 5. Department of Respiratory Medicine, Tohoku University Hospital, 1-1 Seiryo-cho, Aoba-ku, 980-8574, Sendai, Miyagi, Japan. 6. Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, 89-1 Enya-cho, 693-8501, Izumo, Shimane, Japan. 7. Center for Innovative Clinical Medicine, Okayama University Hospital, 2-5-1 Shikata-cho, Kita- ku, 700-8558, Okayama, Japan. 8. Division of Molecular Pharmacology, National Cancer Center Research Institute, 5-1-1 Tsukiji, Chuo-ku, 104-0045, Tokyo, Japan. 9. Department of Medical Oncology, Kyorin University Hospital, 6-20-2 Shinkawa, Mitaka, 181-8611, Tokyo, Japan. 10. Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, 65 Tsurumai- cho, Showa-ku, 466-8560, Nagoya, Japan. 11. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Yoshidahonmachi, Sakyo-ku, 606-8501, Kyoto, Japan.
Abstract
BACKGROUND: In Japan, approximately half of all lung cancer patients are aged > 75 years, and the proportion of older patients is increasing. In older patients, it is necessary to consider comorbidities and concomitant drug use to ensure optimal cancer treatment; however, geriatric assessment (GA) is not widely performed. We plan to conduct a study (ENSURE-GA) of GA in older lung cancer patients to determine whether GA with intervention improves patient satisfaction with their treatment. METHODS: The study will be a phase III comparative clinical trial with a cluster-randomized design, and it will be conducted at 81 sites distributed throughout Japan. Approximately 1000 lung cancer patients aged ≥75 years will be enrolled in the study. All participants will undergo a standardized GA before starting treatment (using an iPad). At the intervention sites, the GA results and intervention method recommended on the basis of the GA results will be returned as an instant report to guide the physician's choice of intervention. At the control sites, the physician will decide on interventions based on standard practice. All participants will complete a patient satisfaction survey before treatment initiation (after the GA) and 3 months later. DISCUSSION: The purpose of the ENSURE-GA study is to evaluate whether GA with interventions improves patient satisfaction with treatment outcomes. The study may lead to the increased use of GA and improved treatment of cancer in older adults. The results will also be used to prepare guidelines for treating older cancer patients and will provide a foundation for the development of a standardized geriatric oncology system. TRIAL REGISTRATION: The study has been registered in the University Hospital Medical Information Network database (no. UMIN000037590). The registration date is August 4, 2019, and the protocol version is 2.0. ( https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042853 .).
RCT Entities:
BACKGROUND: In Japan, approximately half of all lung cancerpatients are aged > 75 years, and the proportion of older patients is increasing. In older patients, it is necessary to consider comorbidities and concomitant drug use to ensure optimal cancer treatment; however, geriatric assessment (GA) is not widely performed. We plan to conduct a study (ENSURE-GA) of GA in older lung cancerpatients to determine whether GA with intervention improves patient satisfaction with their treatment. METHODS: The study will be a phase III comparative clinical trial with a cluster-randomized design, and it will be conducted at 81 sites distributed throughout Japan. Approximately 1000 lung cancerpatients aged ≥ 75 years will be enrolled in the study. All participants will undergo a standardized GA before starting treatment (using an iPad). At the intervention sites, the GA results and intervention method recommended on the basis of the GA results will be returned as an instant report to guide the physician's choice of intervention. At the control sites, the physician will decide on interventions based on standard practice. All participants will complete a patient satisfaction survey before treatment initiation (after the GA) and 3 months later. DISCUSSION: The purpose of the ENSURE-GA study is to evaluate whether GA with interventions improves patient satisfaction with treatment outcomes. The study may lead to the increased use of GA and improved treatment of cancer in older adults. The results will also be used to prepare guidelines for treating older cancerpatients and will provide a foundation for the development of a standardized geriatric oncology system. TRIAL REGISTRATION: The study has been registered in the University Hospital Medical Information Network database (no. UMIN000037590). The registration date is August 4, 2019, and the protocol version is 2.0. ( https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042853 .).
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