TY - JOUR
T1 - Nurse-led, screening-Triggered, early specialised palliative care intervention programme for patients with advanced lung cancer
T2 - Study protocol for a multicentre randomised controlled trial
AU - Fujisawa, Daisuke
AU - Umemura, Shigeki
AU - Okizaki, Ayumi
AU - Satomi, Eriko
AU - Yamaguchi, Takuhiro
AU - Miyaji, Tempei
AU - Mashiko, Tomoe
AU - Kobayashi, Naoko
AU - Kinoshita, Hiroya
AU - Mori, Masanori
AU - Morita, Tatsuya
AU - Uchitomi, Yosuke
AU - Goto, Koichi
AU - Ohe, Yuichiro
AU - Matsumoto, Yoshihisa
N1 - Funding Information:
Funding This work was supported by the Japan Agency for Medical Research and Development (AMED) (grant number JP16ck0106213 and JP19ck0106502), and the Japan Health, Labour and Welfare Sciences Research Grants (grant number of H27-Cancer Control-general-002).
Publisher Copyright:
©
PY - 2020/11/26
Y1 - 2020/11/26
N2 - 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.
AB - 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.
KW - oncology
KW - palliative care
KW - respiratory tract tumours
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U2 - 10.1136/bmjopen-2020-037759
DO - 10.1136/bmjopen-2020-037759
M3 - Article
C2 - 33243791
AN - SCOPUS:85096947195
SN - 2044-6055
VL - 10
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e037759
ER -
