Unique ID issued by UMIN | UMIN000025491 |
---|---|
Receipt number | R000029335 |
Scientific Title | Nurse-led, screening-triggered early specialized palliative care intervention program for advanced lung cancer patients: a randomized controlled trial |
Date of disclosure of the study information | 2017/01/04 |
Last modified on | 2024/01/10 16:16:49 |
Nurse-led, screening-triggered early specialized palliative care intervention program for advanced lung cancer patients: a randomized controlled trial
J-SUPPORT 1603
Nurse-led, screening-triggered early specialized palliative care intervention program for advanced lung cancer patients: a randomized controlled trial
J-SUPPORT 1603
Japan |
Advanced Lung Cancer
Hematology and clinical oncology |
Malignancy
NO
To examine the effectiveness of the nurse-led, screening-triggered early specialized comprehensive palliative care intervention program for advanced lung cancer patients, compared with usual care.
Efficacy
Confirmatory
Phase III
The change in the score on the Functional Assessment of Cancer Therapy-Lung Trial Outcome Index (FACT-L TOI) from baseline to 3 months
(1) FACT-L score
(2) FACT-L Lung Cancer Subscale(LCS) score
(3) Proportion of patients with depression assessed by Patient Health Questionnaire 9 (PHQ-9)
(4) PHQ-9 score
(5) Proportion of patients with anxiety assessed by generalized anxiety disorder 7-item (GAD-7)
(6) GAD-7 score
(7) EuroQol 5 Dimension (EQ-5D) score
(8) Proportion of responses to each item in the questionnaire about illness understanding
(9) Proportion of responses to each item in the questionnaire about medical services received
(10) One-year survival rate
(11) Overall survival
(12) Visiting time with patients taken for each professions belonging to specialized palliative care service to meet with patients
(13) Proportion of the place of death
(14) Days from the last chemotherapy to death
(15) Days of hospital stay in general wards during one month before death
(16) Days of hospice usage during one month before death
(17) Proportion of hospice usage during one month before death
(18) Proportion of cardiopulmonary resuscitation
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Other |
Patients with advanced lung cancer undergoing first-line chemotherapy will receive interventions based on specialized palliative care comprehensive program. The program contains the promotion of the intervention with the brief questionnaire and the specialized palliative care comprehensive program with the nurse-led interdisciplinary approach.
Patients with advanced lung cancer undergoing first-line chemotherapy will receive standard care with specialized palliative care as needed.
20 | years-old | <= |
Not applicable |
Male and Female
(1) Histlogically or cytologically proven lung cancer
(2) Stage IV non-small cell lung cancer or extensive-disease small cell lung cancer
(3)Negative or unknown status of gene mutations for which molecular-targeted therapy is applicable (e.g. EGFR, ALK, ROS1, or BRAF)
(4)Scheduled for first-line chemotherapy (other than immunotherapy)
(5)Absence of history of any previous anticancer treatment for lung cancer (including chemotherapy, surgery, radiation therapy with curative intent and/or immunotherapy)
(6)Initial administration of the first line chemotherapy in inpatient hospital setting
(7) Age >= 20 years
(8) Written informed consent for participation in this study
(1) Already consulted outpatient palliative medicine clinic or outpatient psycho-oncology clinic before entry to this study, and scheduled to receive the medical care subsequently
(2) Already received intervention of specialty palliative care service before entry to this study
(3) With severe cognitive impairment
(4) unable to comprehend Japanese
(5) Already participate in other intervention studies which prohibit participation in this study.
(6) Considered ineligible for this study by the physician in charge
206
1st name | Yoshihisa |
Middle name | |
Last name | Matsumoto |
National Cancer Center Hospital East
Department of Palliative Medicine
277-8577
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
+81-4-7133-1111
yosmatsu@east.ncc.go.jp
1st name | Yoshihisa |
Middle name | |
Last name | Matsumoto |
National Cancer Center Hospital East
Department of Palliative Medicine
277-8577
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
+81-4-7133-1111
yosmatsu@east.ncc.go.jp
National Cancer Center
Japan Agency for Medical Research and Development
Japanese Governmental office
Japan Supportive, Palliative and Psychosocial Oncology Group
National Cancer Center Institutional Review Board
5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
NO
国立がん研究センター東病院
国立がん研究センター中央病院
2017 | Year | 01 | Month | 04 | Day |
https://bmjopen.bmj.com/content/10/11/e037759
Unpublished
204
Delay expected |
The paper is in the process of being submitted to a journal.
No longer recruiting
2016 | Year | 12 | Month | 13 | Day |
2016 | Year | 12 | Month | 28 | Day |
2017 | Year | 01 | Month | 16 | Day |
2021 | Year | 09 | Month | 18 | Day |
2016 | Year | 12 | Month | 31 | Day |
2024 | Year | 01 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029335