Innovation Center for Supportive, Palliative and Psychosocial Care

Yosuke Uchitomi, Yutaka Matsuoka, Sadamoto Zenda, Eriko Satomi, Ken Shimizu, Masashi Kato, Yasuhito Uezono, Takuhiro Yamaguchi, Miki Kawahara, Tempei Miyaji, Yumi Kikukawa, Ayako Sato, Koji Washizuka, Chikako Kusano, Masanori Mori, Shino Umezawa, Maiko Fujimori, Fumio Nagashima

Introduction

We established the Innovation Center for Supportive, Palliative and Psychosocial Care at the National Cancer Center Hospital Japan in 2015. We build J-SUPPORT (Japan Supportive, Palliative and Psychosocial Oncology Group) as an opened hub of a multi-institute collaborative clinical research for supportive, palliative and psychosocial care. This group has five research areas: I) medicine and device development, IIa) supportive care, IIb) palliative care, IIIa) psycho-oncology, IIIb) survivorship care, IV) research methodology, V) needs survey and implementation (Figure1).

Figure 1. Organization of J-SUPPORT

Our team and what we do

We cooperate in providing consultation services and expert advice on clinical research design, and statistical analysis to investigators as they launch new research projects in fields such as supportive, palliative, and psychosocial care. This service includes face-to-face clinical designs and biostatistics consultations, in which we adjust a collaborative study with other study groups and institutions.

Research activities

We held three protocol review committees, and we approved five studies as the J-SUPPORT study (Table 1). Two studies of them were approved by the institutional review boards of researchers'institutes, and recruiting of participants are currently ongoing.

Table 1. J-SUPPORT Study

For J-SUPPORT studies support, we developed structure of operation systems: established a data management team and an independent data monitoring committee. We prepared a form of a monthly report of the J-SUPPORT study, adverse event report, and privacy policy of J-SUPPORT.

After we released the J-SUPPORT website, 140 people across Japan registered as J-SUPPORT members. Through this website, we have consulted three studies from J-SUPPORT members. We are supporting them with a mentor in each research.

Observational trials

- A scripted video-vignette study to explore the best practice in prognostic disclosure

Clinical trials

- Topical steroid versus placebo for the prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiotherapy: a phase III, randomized, double-blind trial

- Nurse-led, screening-triggered early specialized palliative care intervention program for advanced lung cancer patients: randomized controlled trial

- Efficacy and safety of olanzapine 5mg, in combination with standard antiemetic therapy for the treatment of chemotherapy -induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: a randomized, double-blind, placebo-controlled, phase III clinical trial

- Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing a high invasive surgery : a randomized, double-blind, placebo-controlled trial

Education

We held a seminar about clinical researches by two researchers:

1) Naomi Kiyota, MD, PhD (Kobe University): Until the randomized controlled trial starts

2) Chiaki Kawanishi, MD, PhD (Sapporo Medical University): Case management intervention by multi occupational medical team prevent re-attempt of suicide

Future prospects

We plan to hold protocol review committees regularly and are going to support research activity. According to a roadmap (Figure 2), we plan to expand J-SUPPORT as an opened hub to contribute a development of supportive, palliative and psychosocial care for cancer patients. We plan to make a policy of supportive care research and move the schedule forward to make a roadmap of each research area.

Figure 2. A roadmap of J-SUPPORT

List of papers published in 2016

Journal

1.Akizuki N, Shimizu K, Asai M, Nakano T, Okusaka T, Shimada K, Inoguchi H, Inagaki M, Fujimori M, Akechi T, Uchitomi Y. Prevalence and predictive factors of depression and anxiety in patients with pancreatic cancer: a longitudinal study. Jpn J Clin Oncol, 46:71-77, 2016

2.Zenda S, Ota Y, Tachibana H, Ogawa H, Ishii S, Hashiguchi C, Akimoto T, Ohe Y, Uchitomi Y. A prospective picture collection study for a grading atlas of radiation dermatitis for clinical trials in head-and-neck cancer patients. J Radiat Res, 57:301-306, 2016

3.Fujiwara M, Inagaki M, Higuchi Y, Uchitomi Y, Terada S, Kodama M, Kishi Y, Yamada N. An Open-Label Feasibility Trial of Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Major Depressive Episodes. Acta Med Okayama, 70:307-311, 2016

4.Higuchi Y, Inagaki M, Koyama T, Kitamura Y, Sendo T, Fujimori M, Uchitomi Y, Yamada N. A cross-sectional study of psychological distress, burnout, and the associated risk factors in hospital pharmacists in Japan. BMC Public Health, 16:534, 2016

5.Sakamoto S, Takaki M, Okahisa Y, Mizuki Y, Inagaki M, Ujike H, Mitsuhashi T, Takao S, Ikeda M, Uchitomi Y, Iwata N, Yamada N. Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes. J Hum Genet, 61:329-334, 2016

6.Muramatsu S, Shiraishi S, Miyano K, Sudo Y, Toda A, Mogi M, Hara M, Yokoyama A, Kawasaki Y, Taniguchi M, Uezono Y. Metabolism of AM404 From Acetaminophen at Human Therapeutic Dosages in the Rat Brain. Anesth Pain Med, 6:e32873, 2016

7.Murakami S, Sudo Y, Miyano K, Nishimura H, Matoba M, Shiraishi S, Konno H, Uezono Y. Tris-hydroxymethyl-aminomethane enhances capsaicin-induced intracellular Ca2+ influx through transient receptor potential V1 (TRPV1) channels. J Pharmacol Sci, 130:72-77, 2016

8.Tagami K, Kashiwase Y, Yokoyama A, Nishimura H, Miyano K, Suzuki M, Shiraishi S, Matoba M, Ohe Y, Uezono Y. The atypical antipsychotic, olanzapine, potentiates ghrelin-induced receptor signaling: An in vitro study with cells expressing cloned human growth hormone secretagogue receptor. Neuropeptides, 58:93-101, 2016

Book

1.Uezono Y, Miyano K. Pain and Herbal Medicine: Effectiveness of Japanese Kampo Medicines on Pains Associated with Cancer Patients. In: Inui A (ed), Herbal Medicines, Methods in Pharmacology and Toxicology, USA, Springer Science, pp 19-36, 2016