Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study
Takuhiro Yamaguchi,
Tempei Miyaji,
Sadamoto Zenda,
Takashi Kawaguchi,
Miho Saiga,
Yuko Hosoya,
Hiroki Utsunomiya,
Yukiko Kuramoto,
Satoko Watanabe,
Koichi Tomita,
Yukiko Aihara,
Mayu Muto,
Makoto Hikosaka,
Aya Goto,
Minoru Sakuraba,
Taro Kusano,
Kenta Miyabe,
Tomoaki Kuroki,
Tomoyuki Yano,
Mifue Taminato,
Mitsuru Sekido,
Yui Tsunoda,
Toshihiko Satake,
Hiroyoshi Doihara,
Yoshihiro Kimata
Affiliations
Takuhiro Yamaguchi
Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan
Tempei Miyaji
Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
Sadamoto Zenda
Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan
Takashi Kawaguchi
Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan
Miho Saiga
Department of Plastic and Reconstructive Surgery, Okayama University Hospital, Okayama, Japan
Yuko Hosoya
Department of Plastic and Reconstructive Surgery, Iwate Medical University, Morioka, Japan
Hiroki Utsunomiya
Department of Surgery and Plastic Surgery, Showa University Koto Toyosu Hospital, Tokyo, Japan
Yukiko Kuramoto
Department of Plastic and Reconstructive Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
Satoko Watanabe
Department of Plastic and Reconstructive Surgery, Okayama University Hospital, Okayama, Japan
Koichi Tomita
Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan
Yukiko Aihara
Department of Plastic and Reconstructive Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
Mayu Muto
Department of Plastic and Reconstructive Surgery, Yokohama City University Medical Center, Yokohama, Japan
Makoto Hikosaka
Department of Plastic and Reconstructive Surgery, National Center for Child Health and Development, Tokyo, Japan
Aya Goto
3 Center for Integrated Science and Humanities, Fukushima Medical University, Fukushima, Japan
Minoru Sakuraba
Department of Plastic and Reconstructive Surgery, Iwate Medical University, Morioka, Japan
Taro Kusano
Kusano Taro Clinic, Tokyo, Japan
Kenta Miyabe
Department of Plastic and Reconstructive Surgery, Showa University Hospital, Tokyo, Japan
Tomoaki Kuroki
Department of Plastic and Reconstructive Surgery, Showa University Hospital, Tokyo, Japan
Tomoyuki Yano
Department of Plastic and Reconstructive Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
Mifue Taminato
Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan
Mitsuru Sekido
Department of Plastic and Reconstructive Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
Yui Tsunoda
Department of Plastic and Reconstructive Surgery, Yokohama City University Medical Center, Yokohama, Japan
Toshihiko Satake
Department of Plastic and Reconstructive Surgery, Toyama University Hospital, Toyama, Japan
Hiroyoshi Doihara
Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan
Yoshihiro Kimata
Department of Plastic and Reconstructive Surgery, Okayama University Hospital, Okayama, Japan
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.Trial registration number UMIN000032177.
