Nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer: study protocol for a multicentre randomised controlled trial
Takuhiro Yamaguchi,
Tempei Miyaji,
Yosuke Uchitomi,
Tatsuya Morita,
Eriko Satomi,
Masanori Mori,
Yoshihisa Matsumoto,
Yuichiro Ohe,
Tomoe Mashiko,
Daisuke Fujisawa,
Shigeki Umemura,
Ayumi Okizaki,
Naoko Kobayashi,
Hiroya Kinoshita,
Koichi Goto
Affiliations
Takuhiro Yamaguchi
Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan
Tempei Miyaji
Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Yosuke Uchitomi
Division of Survivorship Research, Institute for Cancer Control, National Cancer Center, Tokyo, Japan
Tatsuya Morita
Palliative and Supportive Care, Seirei Mikatahara Hospital, Hamamatsu, Shizuoka, Japan
Eriko Satomi
Department of Palliative Medicine, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Masanori Mori
5 Palliative and Supportive Care Division, Seirei Mikatahara Hospital, Hamamatsu, Japan
Yoshihisa Matsumoto
Department of Palliative Medicine, National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Yuichiro Ohe
Department of Thoracic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Tomoe Mashiko
Division of Supportive Care, Survivorship and Translational Research, National Cancer Center, Tokyo, Japan
Daisuke Fujisawa
Department of Neuropsychiatry and Palliative Care Center, Keio University School of Medicine, Tokyo, Japan
Shigeki Umemura
Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Ayumi Okizaki
Department of Palliative Medicine, National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Naoko Kobayashi
Department of Nursing, National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Hiroya Kinoshita
Department of Palliative Care, Tokatsu Hospital, Nagareyama, Chiba, Japan
Koichi Goto
Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Introduction It has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer.Methods and analysis A total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants’ quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works.Ethics and dissemination This study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy.Trial registration number UMIN000025491.
