UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Nurse-led, screening-triggered early specialized palliative care intervention program for advanced lung cancer patients: a randomized controlled trial
Acronym
J-SUPPORT 1603
Scientific Title
Nurse-led, screening-triggered early specialized palliative care intervention program for advanced lung cancer patients: a randomized controlled trial
Scientific Title:Acronym
J-SUPPORT 1603
Region
| Japan |
Condition
Condition
Advanced Lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The change in the score on the Functional Assessment of Cancer Therapy-Lung Trial Outcome Index (FACT-L TOI) from baseline to 3 months
Key secondary outcomes
(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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
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.
Interventions/Control_2
Patients with advanced lung cancer undergoing first-line chemotherapy will receive standard care with specialized palliative care as needed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(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
Key exclusion criteria
(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
Target sample size
206
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital East
Division name
Department of Palliative Medicine
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
+81-4-7133-1111
yosmatsu@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital East
Division name
Department of Palliative Medicine
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
+81-4-7133-1111
Homepage URL
yosmatsu@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Supportive, Palliative and Psychosocial Oncology Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/10/11/e037759
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
204
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The paper is in the process of being submitted to a journal.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029335
