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2. Dexamethasone-sparing on days 2–4 with combined palonosetron, neurokinin-1 receptor antagonist, and olanzapine in cisplatin: a randomized phase III trial (SPARED Trial)

Author

Minatogawa, Hiroko, Izawa, Naoki, Shimomura, Kazuhiro, Arioka, Hitoshi, Iihara, Hirotoshi, Sugawara, Mitsuhiro, Morita, Hajime, Mochizuki, Ayako, Nawata, Shuichi, Mishima, Keisuke, Tsuboya, Ayako, Miyaji, Tempei, Honda, Kazunori, Yokomizo, Ayako, Hashimoto, Naoya, Yanagihara, Takeshi, Endo, Junki, Kawaguchi, Takashi, Furuya, Naoki, Sone, Yumiko, Inada, Yusuke, Ohno, Yasushi, Katada, Chikatoshi, Hida, Naoya, Akiyama, Kana, Ichikura, Daisuke, Konomatsu, Akiko, Ogura, Takashi, Yamaguchi, Takuhiro, and Nakajima, Takako Eguchi

Published
2024
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4. Protocol for a confirmatory trial of the effectiveness and safety of palliative arterial embolization for painful bone metastases

Author

Zenda, Sadamoto, Arai, Yasunori, Sugawara, Shunsuke, Inaba, Yoshitaka, Hashimoto, Kazuki, Yamamoto, Kouji, Saigusa, Yusuke, Kawaguchi, Takashi, Shimada, Sanae, Yokoyama, Marie, Miyaji, Tempei, Okano, Tomoka, Nakamura, Naoki, Kobayashi, Eisuke, Takagi, Tatsuya, Matsumoto, Yoshihisa, Uchitomi, Yosuke, and Sone, Miyuki

Published
2023
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5. Optimization of smartphone psychotherapy for depression and anxiety among patients with cancer using the multiphase optimization strategy (MOST) framework and decentralized clinical trial system (SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience: SMILE AGAIN project): a protocol for a randomized controlled trial

Author

Uchida, Megumi, Furukawa, Toshiaki A, Yamaguchi, Takuhiro, Imai, Fuminobu, Momino, Kanae, Katsuki, Fujika, Sakurai, Naomi, Miyaji, Tempei, Horikoshi, Masaru, Iwata, Hiroji, Zenda, Sadamoto, Iwatani, Tsuguo, Ogawa, Asao, Inoue, Akira, Abe, Masakazu, Toyama, Tatsuya, Uchitomi, Yosuke, Matsuoka, Hiromichi, Noma, Hisashi, and Akechi, Tatsuo

Published
2023
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8. Optimizing smartphone psychotherapy for depressive symptoms in patients with cancer: Multiphase optimization strategy using a decentralized multicenter randomized clinical trial (J‐SUPPORT 2001 Study).

Author

Akechi, Tatsuo, Furukawa, Toshiaki A., Noma, Hisashi, Iwata, Hiroji, Toyama, Tatsuya, Higaki, Kenji, Matsuoka, Hiromichi, Zenda, Sadamoto, Iwatani, Tsuguo, Akahane, Kazuhisa, Inoue, Akira, Sagara, Yasuaki, Uchida, Megumi, Imai, Fuminobu, Momino, Kanae, Imaizumi, Gen, Yamaguchi, Takuhiro, Mashiko, Tomoe, Miyaji, Tempei, and Horikoshi, Masaru

Subjects
MENTAL depression, PSYCHOTHERAPY, COGNITIVE therapy, CANCER patients, CLINICAL trials
Abstract

Aim: Patients with cancer experience various forms of psychological distress, including depressive symptoms, which can impact quality of life, elevate morbidity risk, and increase medical costs. Psychotherapy and pharmacotherapy are effective for reducing depressive symptoms among patients with cancer, but most patients prefer psychotherapy. This study aimed to develop an efficient and effective smartphone psychotherapy component to address depressive symptom. Methods: This was a decentralized, parallel‐group, multicenter, open, individually randomized, fully factorial trial. Patients aged ≥20 years with cancer were randomized by the presence/absence of three cognitive‐behavioral therapy (CBT) skills (behavioral activation [BA], assertiveness training [AT], and problem‐solving [PS]) on a smartphone app. All participants received psychoeducation (PE). The primary outcome was change in the patient health questionnaire‐9 (PHQ‐9) total score between baseline and week 8. Secondary outcomes included anxiety. Results: In total, 359 participants were randomized. Primary outcome data at week 8 were obtained for 355 participants (99%). The week 8 PHQ‐9 total score was significantly reduced from baseline for all participants by −1.41 points (95% confidence interval [CI] −1.89, −0.92), but between‐group differences in change scores were not significant (BA: −0.04, 95% CI −0.75, 0.67; AT: −0.16, 95% CI −0.87, 0.55; PS: −0.19, 95% CI −0.90, 0.52). Conclusion: As the presence of any of the three intervention components did not contribute to a significant additive reduction of depressive symptoms, we cannot make evidence‐based recommendations regarding the use of specific smartphone psychotherapy. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Additive Duloxetine for Cancer-Related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy: A Randomized Controlled Trial (JORTC-PAL08)

Author

Matsuoka, Hiromichi, Iwase, Satoru, Miyaji, Tempei, Kawaguchi, Takashi, Ariyoshi, Keisuke, Oyamada, Shunsuke, Satomi, Eriko, Ishiki, Hiroto, Hasuo, Hideaki, Sakuma, Hiroko, Tokoro, Akihiro, Shinomiya, Toshiaki, Otani, Hiroyuki, Ohtake, Yoichi, Tsukuura, Hiroaki, Matsumoto, Yoshihisa, Hasegawa, Yoshikazu, Kataoka, Yuki, Otsuka, Masatomo, Sakai, Kiyohiro, Matsuda, Yoshinobu, Morita, Tatsuya, Koyama, Atsuko, and Yamaguchi, Takuhiro

Published
2019
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10. Prevalence of psychological distress and associated factors among patients undergoing comprehensive genomic profiling testing: protocol for a multicentre, prospective, observational study

Author

Matsuoka, Ayumu, primary, Fujimori, Maiko, additional, Koyama, Takafumi, additional, Sato, Ayako, additional, Mori, Keita, additional, Hirata, Makoto, additional, Tanabe, Noriko, additional, Nakachi, Kohei, additional, Kato, Shunsuke, additional, Okamoto, Hiroaki, additional, Ogawa, Kohei, additional, Komatsu, Hirokazu, additional, Iwasaku, Masahiro, additional, Miyaji, Tempei, additional, and Uchitomi, Yosuke, additional

Published
2023
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11. Registry study of immune-related adverse events using electronic patient-reported outcome in patients with cancer receiving immune checkpoint inhibitors: protocol for a multicentre cohort study

Author

Hirata, Taiki, primary, Kawaguchi, Takashi, additional, Azuma, Kanako, additional, Torii, Ayako, additional, Usui, Hiroaki, additional, Kim, Soan, additional, Hayama, Tatsuya, additional, Hirate, Daisuke, additional, Kawahara, Yosuke, additional, Kumihashi, Yuki, additional, Chisaka, Tomomi, additional, Wako, Tetsuya, additional, Yoshimura, Akinobu, additional, Miyaji, Tempei, additional, and Yamaguchi, Takuhiro, additional

Published
2023
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12. Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy

Author

Kuniyoshi, Ouki, primary, Sano, Motohiko, additional, Nakano, Yasuhiro, additional, Kawaguchi, Takashi, additional, Hatakeyama, Tomoki, additional, Tsuchiya, Yusuke, additional, Inada, Yusuke, additional, Harada, Tomohiko, additional, Kurosaki, Miyuki, additional, Mashiko, Tomoe, additional, Miyaji, Tempei, additional, and Yamaguchi, Takuhiro, additional

Published
2023
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13. Patient-reported outcome and quality of life research policy: Japan Clinical Oncology Group (JCOG) policy

Author

Ishiki, Hiroto, Kikawa, Yuichiro, Terada, Mitsumi, Mizusawa, Junki, Honda, Michitaka, Iwatani, Tsuguo, Mizutani, Tomonori, Mori, Keita, Nakamura, Naoki, Miyaji, Tempei, Yamaguchi, Takuhiro, Ando, Masahiko, Nakamura, Kenichi, Fukuda, Haruhiko, Kiyota, Naomi, and PRO/QOL research Committee of Japan Clinical Oncology Group

Subjects
health-related quality of life, Cancer Research, study design, Oncology, quality of life, endpoint, Radiology, Nuclear Medicine and imaging, General Medicine, patient-reported outcome, JCOG
Abstract

Assessments of patient-reported outcomes and health-related quality of life in cancer clinical trials have been increasingly emphasized recently because patient and public involvement in cancer treatment development has been promoted by regulatory authorities and academic societies. To assess patient experiences during and after cancer treatment, there is interest in implementing patient-reported outcome and health-related quality of life assessments into cancer clinical trials.The Japan Clinical Oncology Group quality of life ad hoc committee previously created a version of the Quality of Life Assessment Policy in 2006. Recently, there has been increasing demand from Japan Clinical Oncology Group researchers to assess patient-reported outcome/health-related quality of life in clinical trials. Although guidelines are available regarding planning and reporting clinical trials that include patient-reported outcome/health-related quality of life as an endpoint, there are still issues regarding the lack of consensus on standardized methods for analysing and interpreting the results. Hence, it was considered necessary to reorganize the Japan Clinical Oncology Group patient-reported outcome/quality of life research committee and to revise the former patient-reported outcome/quality of life research policy to promote patient-reported outcome/health-related quality of life research in future Japan Clinical Oncology Group trials.The purpose of this Japan Clinical Oncology Group patient-reported outcome/quality of life research policy is to define patient-reported outcome/health-related quality of life research and provide guidelines for including patient-reported outcome/health-related quality of life as an endpoint in Japan Clinical Oncology Group trials.

Published
2023

14. Preoperative steroid for enhancing patients’ recovery after head and neck cancer surgery with free tissue transfer reconstruction: protocol for a phase III, placebo-controlled, randomised, double-blind study (J-SUPPORT 2022, PreSte-HN Study)

Author

Shinozaki, Takeshi, primary, Imai, Takayuki, additional, Kobayashi, Kenya, additional, Yoshimoto, Seiichi, additional, Zenda, Sadamoto, additional, Yamaguchi, Takuhiro, additional, Eguchi, Kohtaro, additional, Okano, Tomoka, additional, Mashiko, Tomoe, additional, Kurosaki, Miyuki, additional, Miyaji, Tempei, additional, and Matsuura, Kazuto, additional

Published
2023
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15. Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)

Author

Obama, Kyoko, primary, Fujimori, Maiko, additional, Okamura, Masako, additional, Kadowaki, Midori, additional, Ueno, Taro, additional, Boku, Narikazu, additional, Mori, Masanori, additional, Akechi, Tatsuo, additional, Yamaguchi, Takuhiro, additional, Oyamada, Shunsuke, additional, Okizaki, Ayumi, additional, Miyaji, Tempei, additional, Sakurai, Naomi, additional, and Uchitomi, Yosuke, additional

Published
2023
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16. Protocol for the RETHINK study: a randomised, double-blind, parallel-group, non-inferiority clinical trial comparing acetaminophen and NSAIDs for treatment of chronic pain in elderly patients with osteoarthritis of the hip and knee

Author

Endo, Makoto, primary, Kawahara, Shinya, additional, Sato, Taishi, additional, Tokunaga, Masami, additional, Hara, Toshihiko, additional, Mawatari, Taro, additional, Kawano, Tsutomu, additional, Zenda, Sadamoto, additional, Miyaji, Tempei, additional, Shimokawa, Mototsugu, additional, Sakamoto, Sanae, additional, Takano, Toshio, additional, Miyake, Masumi, additional, Aono, Hiroyuki, additional, and Nakashima, Yasuharu, additional

Published
2023
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17. Geriatric assessment and management with question prompt list using a web-based application for elderly patients with cancer (MAPLE) to communicate ageing-related concerns: J-SUPPORT 2101 study protocol for a multicentre, parallel group, randomised controlled trial

Author

Matsuoka, Ayumu, primary, Fujimori, Maiko, additional, Narikazu, Boku, additional, Takashima, Atsuo, additional, Okusaka, Takuji, additional, Mori, Keita, additional, Akechi, Tatsuo, additional, Shimazu, Taichi, additional, Okizaki, Ayumi, additional, Miyaji, Tempei, additional, Majima, Yoshiyuki, additional, Nagashima, Fumio, additional, and Uchitomi, Yosuke, additional

Published
2022
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18. Topical steroid versus placebo for the prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiotherapy: the study protocol of J-SUPPORT 1602 (TOPICS study), a randomized double-blinded phase 3 trial

Author

Zenda, Sadamoto, Yamaguchi, Takuhiro, Yokota, Tomoya, Miyaji, Tempei, Mashiko, Tomoe, Tanaka, Mari, Yonemura, Masahito, Takeno, Misaki, Okano, Tomoka, Kawasaki, Toshikatsu, Nakamori, Yuko, Ishii, Shinobu, Shimada, Sanae, Kanamaru, Miyuki, and Uchitomi, Yosuke

Published
2018
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19. The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events

Author

Kawaguchi, Takashi, Azuma, Kanako, Sano, Motohiko, Kim, Soan, Kawahara, Yosuke, Sano, Yoko, Shimodaira, Tomohide, Ishibashi, Keiichiro, Miyaji, Tempei, Basch, Ethan, and Yamaguchi, Takuhiro

Published
2018
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20. P69-8 Effectiveness of the Early Palliative Care Intervention Program on depression and anxiety: A randomized controlled trial

Author

Okizaki, Ayumi, primary, Yoshihisa, Matsumoto, additional, Daisuke, Fujisawa, additional, Daisuke, Kiuchi, additional, Umemura, Shigeki, additional, Yamaguchi, Takuhiro, additional, Oyamada, Syunsuke, additional, Kobayashi, Naoko, additional, Miyaji, Tempei, additional, Mashiko, Tomoe, additional, Satomi, Eriko, additional, Mori, Masanori, additional, Goto, Koichi, additional, Ohe, Yuichiro, additional, Uchitomi, Yosuke, additional, and Morita, Tatsuya, additional

Published
2022
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22. Patients’ acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualitative secondary analysis of a mixed-method randomised clinical trial

Author

Yamada, Yuto, primary, Fujiwara, Masaki, additional, Shimazu, Taichi, additional, Etoh, Tsuyoshi, additional, Kodama, Masafumi, additional, So, Ryuhei, additional, Matsushita, Takanori, additional, Yoshimura, Yusaku, additional, Horii, Shigeo, additional, Fujimori, Maiko, additional, Takahashi, Hirokazu, additional, Nakaya, Naoki, additional, Miyaji, Tempei, additional, Hinotsu, Shiro, additional, Harada, Keita, additional, Okada, Hiroyuki, additional, Uchitomi, Yosuke, additional, Yamada, Norihito, additional, and Inagaki, Masatoshi, additional

Published
2022
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23. Phase III, international, multicentre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin for opioid-unresponsive neuropathic cancer pain: A JORTC-PAL16 trial protocol

Author

Matsuoka, Hiromichi, Clark, Katherine, Fazekas, Belinda, Oyamada, Shunsuke, Brown, Linda, Ishiki, Hiroto, Matsuda, Yoshinobu, Hasuo, Hideaki, Ariyoshi, Keisuke, Lee, Jessica, Le, Brian, Allcroft, Peter, Kochovska, Slavica, Fujiwara, Noriko, Miyaji, Tempei, Lovell, Melanie, Agar, Meera, Yamaguchi, Takuhiro, Satomi, Eriko, Iwase, Satoru, Phillips, Jane, Koyama, Atsuko, Currow, David C., Matsuoka, Hiromichi, Clark, Katherine, Fazekas, Belinda, Oyamada, Shunsuke, Brown, Linda, Ishiki, Hiroto, Matsuda, Yoshinobu, Hasuo, Hideaki, Ariyoshi, Keisuke, Lee, Jessica, Le, Brian, Allcroft, Peter, Kochovska, Slavica, Fujiwara, Noriko, Miyaji, Tempei, Lovell, Melanie, Agar, Meera, Yamaguchi, Takuhiro, Satomi, Eriko, Iwase, Satoru, Phillips, Jane, Koyama, Atsuko, and Currow, David C.

Abstract

Introduction: Management of neuropathic cancer pain (NCP) refractory to regular opioids remains an important challenge. The efficacy of pregabalin for NCP except chemotherapy-induced peripheral neuropathy (CIPN) has already been confirmed in two randomised controlled trials (RCTs) compared with placebo. Duloxetine offers the potential of analgesia in opioid refractory NCP. However, there are no RCT of duloxetine for the management of opioid-refractory NCP as a first line treatment. Both classes of drugs have the potential to reduce NCP, but there has been no head-to-head comparison for the efficacy and safety, especially given differing side effect profiles. Methods and analysis: An international, multicentre, double-blind, dose increment, parallel-arm, RCT is planned. Inclusion criteria include: adults with cancer experiencing NCP refractory to opioids; Brief Pain Inventory (BPI)-item 3 (worst pain) of ≥4; Neuropathic Pain on the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale of ≥12 despite of an adequate trial of regular opioid medication (≥60 mg/day oral morphine equivalent dose). Patients with CIPN are excluded. The study will recruit from palliative care teams (both inpatients and outpatients) in Japan and Australia. Participants will be randomised (1:1 allocation ratio) to duloxetine or pregabalin arm. Dose escalation is until day 14 and from day 14 to 21 is a dose de-escalation period to avoid withdrawal effects. The primary endpoint is defined as the mean difference in BPI item 3 for worst pain intensity over the previous 24 hours at day 14 between groups. A sample size of 160 patients will be enrolled between February 2020 and March 2023. Ethics and dissemination: Ethics approval was obtained at Osaka City University Hospital Certified Review Board and South Western Sydney Local Health District Human Research Ethics Committee. The results of this study will be submitted for publication in international journals and

Published
2022

24. Patients' acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualitative secondary analysis of a mixed-method randomised clinical trial

Author

Yamada, Yuto, Fujiwara, Masaki, Shimazu, Taichi, Etoh, Tsuyoshi, Kodama, Masafumi, So, Ryuhei, Matsushita, Takanori, Yoshimura, Yusaku, Horii, Shigeo, Fujimori, Maiko, Takahashi, Hirokazu, Nakaya, Naoki, Miyaji, Tempei, Hinotsu, Shiro, Harada, Keita, Okada, Hiroyuki, Uchitomi, Yosuke, Yamada, Norihito, Inagaki, Masatoshi, Yamada, Yuto, Fujiwara, Masaki, Shimazu, Taichi, Etoh, Tsuyoshi, Kodama, Masafumi, So, Ryuhei, Matsushita, Takanori, Yoshimura, Yusaku, Horii, Shigeo, Fujimori, Maiko, Takahashi, Hirokazu, Nakaya, Naoki, Miyaji, Tempei, Hinotsu, Shiro, Harada, Keita, Okada, Hiroyuki, Uchitomi, Yosuke, Yamada, Norihito, and Inagaki, Masatoshi

Abstract

Objectives We examined the efficacy of case management (CM) interventions to encourage participation in colorectal cancer screening for patients with schizophrenia. This study aimed to clarify patients' acceptability of the intervention and the helpful components of the intervention. Simultaneously, the study aimed to determine the acceptability, appropriateness and feasibility of the intervention from the perspective of psychiatric care providers. Study design and setting This study was a secondary qualitative analysis of a mixed-method randomised controlled trial that evaluated the efficacy of the CM approach to encourage participation in cancer screening for people with schizophrenia. The intervention comprised education and patient navigation for colorectal cancer screening. Interviews were conducted with patients who received the intervention and staff from two psychiatric hospitals in Japan who delivered the intervention. Participants Of the 172 patients with schizophrenia who participated in the trial, 153 were included. In addition, three out of six providers were included. Data collection and analysis Using a structured interview, the case manager asked participants about patient acceptability and the helpful components of the intervention. Content analysis was conducted for the responses obtained, and the number of responses was tabulated by two researchers. For the interviews with the providers, opinions obtained from verbatim transcripts were extracted and summarised. Results Forty-three of the 56 patients perceived that the intervention was acceptable. For the intervention component, inperson counselling with an explanation of the screening process by psychiatric care providers was most frequently reported by the patients as helpful (48 of the 68 respondents). Psychiatric care providers evaluated the intervention as acceptable, appropriate and easy to understand and administer. However, providing the intervention to all patients simultaneously was consi

Published
2022

25. Phase III, international, multicentre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin for opioid-unresponsive neuropathic cancer pain: a JORTC-PAL16 trial protocol

Author

Matsuoka, Hiromichi, primary, Clark, Katherine, additional, Fazekas, Belinda, additional, Oyamada, Shunsuke, additional, Brown, Linda, additional, Ishiki, Hiroto, additional, Matsuda, Yoshinobu, additional, Hasuo, Hideaki, additional, Ariyoshi, Keisuke, additional, Lee, Jessica, additional, Le, Brian, additional, Allcroft, Peter, additional, Kochovska, Slavica, additional, Fujiwara, Noriko, additional, Miyaji, Tempei, additional, Lovell, Melanie, additional, Agar, Meera, additional, Yamaguchi, Takuhiro, additional, Satomi, Eriko, additional, Iwase, Satoru, additional, Phillips, Jane, additional, Koyama, Atsuko, additional, and Currow, David C, additional

Published
2022
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29. An observational study on nutrition status in gastric cancer patients receiving ramucirumab plus taxane: BALAST study

Author

Mizukami, Takuro, primary, Miyaji, Tempei, additional, Narita, Yukiya, additional, Matsushima, Tomohiro, additional, Ogura, Takashi, additional, Miyagaki, Hiromichi, additional, Kawabata, Ryohei, additional, Horie, Yoshiki, additional, Kawaguchi, Takashi, additional, Muro, Kei, additional, Hara, Hiroki, additional, Yamaguchi, Takuhiro, additional, and E Nakajima, Takako, additional

Published
2021
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30. Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study

Author

Saiga, Miho, Hosoya, Yuko, Utsunomiya, Hiroki, Kuramoto, Yukiko, Watanabe, Satoko, Tomita, Koichi, Aihara, Yukiko, Muto, Mayu, Hikosaka, Makoto, Kawaguchi, Takashi, Miyaji, Tempei, Yamaguchi, Takuhiro, Zenda, Sadamoto, Goto, Aya, Sakuraba, Minoru, Kusano, Taro, Miyabe, Kenta, Kuroki, Tomoaki, Yano, Tomoyuki, Taminato, Mifue, Sekido, Mitsuru, Tsunoda, Yui, Satake, Toshihiko, Doihara, Hiroyoshi, Kimata, Yoshihiro, Saiga, Miho, Hosoya, Yuko, Utsunomiya, Hiroki, Kuramoto, Yukiko, Watanabe, Satoko, Tomita, Koichi, Aihara, Yukiko, Muto, Mayu, Hikosaka, Makoto, Kawaguchi, Takashi, Miyaji, Tempei, Yamaguchi, Takuhiro, Zenda, Sadamoto, Goto, Aya, Sakuraba, Minoru, Kusano, Taro, Miyabe, Kenta, Kuroki, Tomoaki, Yano, Tomoyuki, Taminato, Mifue, Sekido, Mitsuru, Tsunoda, Yui, Satake, Toshihiko, Doihara, Hiroyoshi, and Kimata, Yoshihiro

Abstract

Introduction The aim of breast reconstruction (BR) is to improve patients' health-related quality of life (HRQOL). Therefore, measuring patient-reported outcomes (PROs) would clarify the value and impact of BR on a patient's life and thus would provide evidence-based information to help decision-making. The Satisfaction and Quality of Life After Immediate Breast Reconstruction study aimed to investigate satisfaction and HRQOL in Japanese patients with breast cancer who undergo immediate breast reconstruction (IBR). Methods and analysis This ongoing prospective, observational multicentre study will assess 406 patients who had unilateral breast cancer and underwent mastectomy and IBR, and were recruited from April 2018 to July 2019. All participants were recruited from seven hospitals: Okayama University Hospital, Iwate Medical University Hospital, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Showa University Hospital, University of Tsukuba Hospital, Osaka University Hospital and Yokohama City University Medical Center. The patients will be followed up for 36 months postoperatively. The primary endpoint of this study will be the time-dependent changes in BREAST-Q satisfaction with breast subscale scores for 12 months after reconstructive surgery, which will be collected via an electronic PRO system. Ethics and dissemination This study will be performed in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science and Technology and the Ministry of Health, Labour and Welfare, the modified Act on the Protection of Personal Information and the Declaration of Helsinki. This study protocol was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, on 2 February 2018 (1801-039) and all other participating sites. The findings of this trial will be submitted to an international peer-reviewed journal.

Published
2021

31. Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study

Author

Saiga, Miho, primary, Hosoya, Yuko, additional, Utsunomiya, Hiroki, additional, Kuramoto, Yukiko, additional, Watanabe, Satoko, additional, Tomita, Koichi, additional, Aihara, Yukiko, additional, Muto, Mayu, additional, Hikosaka, Makoto, additional, Kawaguchi, Takashi, additional, Miyaji, Tempei, additional, Yamaguchi, Takuhiro, additional, Zenda, Sadamoto, additional, Goto, Aya, additional, Sakuraba, Minoru, additional, Kusano, Taro, additional, Miyabe, Kenta, additional, Kuroki, Tomoaki, additional, Yano, Tomoyuki, additional, Taminato, Mifue, additional, Sekido, Mitsuru, additional, Tsunoda, Yui, additional, Satake, Toshihiko, additional, Doihara, Hiroyoshi, additional, and Kimata, Yoshihiro, additional

Published
2021
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32. Study protocol for SPARED trial: randomised non-inferiority phase III trial comparing dexamethasone on day 1 with dexamethasone on days 1–4, combined with neurokinin-1 receptor antagonist, palonosetron and olanzapine (5 mg) in patients receiving cisplatin-based chemotherapy

Author

Minatogawa, Hiroko, primary, Izawa, Naoki, additional, Kawaguchi, Takashi, additional, Miyaji, Tempei, additional, Shimomura, Kazuhiro, additional, Kazunori, Honda, additional, Iihara, Hirotoshi, additional, Ohno, Yasushi, additional, Inada, Yusuke, additional, Arioka, Hitoshi, additional, Morita, Hajime, additional, Hida, Naoya, additional, Sugawara, Mitsuhiro, additional, Katada, Chikatoshi, additional, Nawata, Shuichi, additional, Ishida, Hiroo, additional, Tsuboya, Ayako, additional, Tsuda, Takashi, additional, Yamaguchi, Takuhiro, additional, and Nakajima, Takako Eguchi, additional

Published
2020
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33. Nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer: study protocol for a multicentre randomised controlled trial

Author

Fujisawa, Daisuke, primary, Umemura, Shigeki, additional, Okizaki, Ayumi, additional, Satomi, Eriko, additional, Yamaguchi, Takuhiro, additional, Miyaji, Tempei, additional, Mashiko, Tomoe, additional, Kobayashi, Naoko, additional, Kinoshita, Hiroya, additional, Mori, Masanori, additional, Morita, Tatsuya, additional, Uchitomi, Yosuke, additional, Goto, Koichi, additional, Ohe, Yuichiro, additional, and Matsumoto, Yoshihisa, additional

Published
2020
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34. Hydrocolloid dressing as a prophylactic use for hand–foot skin reaction induced by multitargeted kinase inhibitors: protocol of a phase 3 randomised self-controlled study

Author

Zenda, Sadamoto, primary, Ryu, Asako, additional, Takashima, Atsuo, additional, Arai, Michiko, additional, Takagi, Yusuke, additional, Miyaji, Tempei, additional, Mashiko, Tomoe, additional, Shimizu, Yoichi, additional, Yamazaki, Naoya, additional, Morizane, Chigusa, additional, Yamaguchi, Takuhiro, additional, Kawaguchi, Takashi, additional, Hanai, Akiko, additional, Uchitomi, Yosuke, additional, and Oshiba, Fukuko, additional

Published
2020
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35. Integrated communication support program for oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication: J-SUPPORT 1904 study protocol for a randomised controlled trial

Author

Fujimori, Maiko, primary, Sato, Ayako, additional, Jinno, Sayaka, additional, Okusaka, Takuji, additional, Yamaguchi, Takuhiro, additional, Ikeda, Masafumi, additional, Ueno, Makoto, additional, Ozaka, Masato, additional, Takayama, Yukiko, additional, Miyaji, Tempei, additional, Majima, Yoshiyuki, additional, and Uchitomi, Yosuke, additional

Published
2020
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36. A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics: study protocol for the J-SUPPORT 1901 (ACCESS) study

Author

Fujiwara, Masaki, INAGAKI, Masatoshi, Shimazu, Taichi, Kodama, Masafumi, So, Ryuhei, Matsushita, Takanori, Yoshimura, Yusaku, Horii, Shigeo, Fujimori, Maiko, Takahashi, Hirokazu, Nakaya, Naoki, Kakeda, Kyoko, Miyaji, Tempei, Hinotsu, Shiro, Harada, Keita, Okada, Hiroyuki, Uchitomi, Yosuke, Yamada, Norihito, Fujiwara, Masaki, INAGAKI, Masatoshi, Shimazu, Taichi, Kodama, Masafumi, So, Ryuhei, Matsushita, Takanori, Yoshimura, Yusaku, Horii, Shigeo, Fujimori, Maiko, Takahashi, Hirokazu, Nakaya, Naoki, Kakeda, Kyoko, Miyaji, Tempei, Hinotsu, Shiro, Harada, Keita, Okada, Hiroyuki, Uchitomi, Yosuke, and Yamada, Norihito

Published
2019

37. The clinical use of Kampo medicines (traditional Japanese herbal treatments) for controlling cancer patients’ symptoms in Japan: a national cross-sectional survey

Author

Iwase Satoru, Yamaguchi Takuhiro, Miyaji Tempei, Terawaki Kiyoshi, Inui Akio, and Uezono Yasuhito

Subjects
Kampo, Kampo medicine, Palliative care, Symptom management, Survey, Other systems of medicine, RZ201-999
Abstract

Abstract Background Kampo medicines are traditional Japanese medicines produced from medicinal plants and herbs. Even though the efficacy of Kampo medicines for controlling cancer-related symptoms is being reported, their actual nationwide clinical use has not been comprehensively investigated. We aimed to investigate physicians’ recognition of Kampo medicines and their clinical use for cancer patients in the field of palliative care. Methods A cross-sectional self-administered anonymous questionnaire was distributed to 549 physicians working in palliative care teams at 388 core cancer treatment hospitals and 161 certified medical institutions that have palliative care units (PCUs). Results Valid responses were obtained from 311 physicians (response rate, 56.7%) who were evenly distributed throughout the country without significant geographical biases. Kampo medicines were prescribed for controlling cancer-related symptoms by 64.3% of the physicians. The symptoms treated with Kampo medicines were numbness/hypoesthesia (n = 99, 49.5%), constipation (n = 76, 38.0%), anorexia/weight loss (n = 72, 36%), muscle cramps (n = 71, 35.5%) and languor/fatigue (n = 64, 32.0%). Regarding open issues about prescription, 60.7% (n = 173) of the physicians raised the issue that the dosage forms need to be better devised. Conclusions To increase the clinical use of Kampo medicines, more evidence from clinical studies is necessary. In addition, their mechanisms of action should be clarified through laboratory studies.

Published
2012
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38. A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics: study protocol for the J-SUPPORT 1901 (ACCESS) study

Author

Fujiwara, Masaki, primary, Inagaki, Masatoshi, additional, Shimazu, Taichi, additional, Kodama, Masafumi, additional, So, Ryuhei, additional, Matsushita, Takanori, additional, Yoshimura, Yusaku, additional, Horii, Shigeo, additional, Fujimori, Maiko, additional, Takahashi, Hirokazu, additional, Nakaya, Naoki, additional, Kakeda, Kyoko, additional, Miyaji, Tempei, additional, Hinotsu, Shiro, additional, Harada, Keita, additional, Okada, Hiroyuki, additional, Uchitomi, Yosuke, additional, and Yamada, Norihito, additional

Published
2019
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39. Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial

Author

Akechi, Tatsuo, primary, Yamaguchi, Takuhiro, additional, Uchida, Megumi, additional, Imai, Fuminobu, additional, Momino, Kanae, additional, Katsuki, Fujika, additional, Sakurai, Naomi, additional, Miyaji, Tempei, additional, Horikoshi, Masaru, additional, Furukawa, Toshi A, additional, Iwata, Hiroji, additional, and Uchitomi, Yosuke, additional

Published
2018
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40. Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Author

Miyaji, Tempei, primary, Iioka, Yukiko, additional, Kuroda, Yujiro, additional, Yamamoto, Daigo, additional, Iwase, Satoru, additional, Goto, Yasushi, additional, Tsuboi, Masahiro, additional, Odagiri, Hiroki, additional, Tsubota, Yu, additional, Kawaguchi, Takashi, additional, Sakata, Naoko, additional, Basch, Ethan, additional, and Yamaguchi, Takuhiro, additional

Published
2017
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41. Study protocol for a multi-institutional, randomised, double-blinded, placebo-controlled phase III trial investigating additive efficacy of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids: the DIRECT study

Author

Matsuoka, Hiromichi, primary, Ishiki, Hiroto, additional, Iwase, Satoru, additional, Koyama, Atsuko, additional, Kawaguchi, Takashi, additional, Kizawa, Yoshiyuki, additional, Morita, Tatsuya, additional, Matsuda, Yoshinobu, additional, Miyaji, Tempei, additional, Ariyoshi, Keisuke, additional, and Yamaguchi, Takuhiro, additional

Published
2017
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43. Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02)

Author

Ohnishi, Shunsuke, primary, Watari, Hidemichi, additional, Kanno, Maki, additional, Ohba, Yoko, additional, Takeuchi, Satoshi, additional, Miyaji, Tempei, additional, Oyamada, Shunsuke, additional, Nomura, Eiji, additional, Kato, Hidenori, additional, Sugiyama, Toru, additional, Asaka, Masahiro, additional, Sakuragi, Noriaki, additional, Yamaguchi, Takuhiro, additional, Uezono, Yasuhito, additional, and Iwase, Satoru, additional

Published
2017
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45. Longer latency of sensory response to intravenous odor injection predicts olfactory neural disorder

Author

Kikuta, Shu, primary, Matsumoto, Yu, additional, Kuboki, Akihito, additional, Nakayama, Tsuguhisa, additional, Asaka, Daiya, additional, Otori, Nobuyoshi, additional, Kojima, Hiromi, additional, Sakamoto, Takashi, additional, Akinori, Kashio, additional, Kanaya, Kaori, additional, Ueha, Rumi, additional, Kagoya, Ryoji, additional, Nishijima, Hironobu, additional, Toma-Hirano, Makiko, additional, Kikkawa, Yayoi, additional, Kondo, Kenji, additional, Tsunoda, Koichi, additional, Miyaji, Tempei, additional, Yamaguchi, Takuhiro, additional, Kataoka, Kazunori, additional, Mori, Kensaku, additional, and Yamasoba, Tatsuya, additional

Published
2016
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46. Assessment of Cancer-Related Fatigue, Pain, and Quality of Life in Cancer Patients at Palliative Care Team Referral: A Multicenter Observational Study (JORTC PAL-09)

Author

Iwase, Satoru, primary, Kawaguchi, Takashi, additional, Tokoro, Akihiro, additional, Yamada, Kimito, additional, Kanai, Yoshiaki, additional, Matsuda, Yoshinobu, additional, Kashiwaya, Yuko, additional, Okuma, Kae, additional, Inada, Shuji, additional, Ariyoshi, Keisuke, additional, Miyaji, Tempei, additional, Azuma, Kanako, additional, Ishiki, Hiroto, additional, Unezaki, Sakae, additional, and Yamaguchi, Takuhiro, additional

Published
2015
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48. The Japanese version of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events.

Author

Kawaguchi T, Azuma K, Sano M, Kim S, Kawahara Y, Sano Y, Shimodaira T, Ishibashi K, Miyaji T, Basch E, and Yamaguchi T

Abstract

Background: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute as an adverse event assessment system to evaluate patients' symptoms, which tend to be underestimated in cancer clinical trials. The aim of this study was to assess the psychometric properties of the Japanese version of the PRO-CTCAE and the degree of adverse event assessment discordance between clinicians and patients., Methods: A total of 187 cancer patients receiving systemic therapy were enrolled. Reproducibility, criterion validity, and responsiveness of the Japanese version of PROCTCAE were assessed. The EORTC QLQ-C30 was used as an external anchor. Discordance of assessment of adverse events between clinician and patients were also assessed using the CTCAE and PRO-CTCAE., Results: A total of 187 participants (187 for criterion validity, 80 for reproducibility, and 100 for responsiveness), were analyzed (Mage = 62.4 years). All patients responded to at least one symptom item (M = 16). The mean (SD) intra-class correlation coefficients of overall reproducibility for the Japanese PRO-CTCAE was 0.63 (0.02). The correlation coefficient for the corresponding items in the EORTC QLQ-C30 and the Japanese PRO-CTCAE was high (Pearson r  = 0.56-0.76). The analysis of responsiveness revealed significant dose-response trends (Jonckheere-Terpstra test, ps < 0.001). Depending on the adverse events, a discrepancy was observed in evaluation between the clinician and patient., Conclusions: These results revealed that there is underestimation in the assessment of adverse events in Japan, and that the Japanese version of the PRO-CTCAE had acceptable reliability and validity for common and clinically important symptoms., Competing Interests: The study protocol was approved by the institutional review board at each institution (Independent Ethics Committee of Tokyo Medical University, No.2758, 29 May 2014. Institutional Review Board of Saitama Medical Center, Saitama Medical University, No.1074, 27 November 2014. Ethics Committee of The Juntendo University Nerima Hospital, No. 14–31, 11 November 2014. Ethics Committee of Toshiba General Hospital, No. 14-A-14, 25 August 2014.) The study was conducted in accordance with the Japanese Ethical Guidelines for Epidemiological Research and was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000014277). All procedures performed were in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.Written informed consent was obtained from all individual participants included in this study.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Published
2017
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