UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025491
Receipt No. 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 2017/01/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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) Histologically or cytologically proven lung cancer
(2) Stage IV non-small cell lung cancer or extensive-disease small cell lung cancer
(3) Negative or unknown of EGFR gene mutation
(4) Negative or unknown of ALK fusion gene
(5) Undergoing first-line chemotherapy at institutions participating in this study
(6) Not performed anticancer therapy (chemotherapy, radical surgery, definitive radiotherapy)
(7)Initial administration of the first line chemotherapy in inpatient hospital setting
(8) Age >= 20 years
(9) 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 diagnosis
(3) With severe cognitive impairment
(4) Unable to read and respond to questions in Japanese
(5) Participate in other intervention studies which prohibit participation in this study.
(6) Judged to be inappropriate for participation to this study
Target sample size 206

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Matsumoto
Organization National Cancer Center Hospital East
Division name Department of Palliative Medicine
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL +81-4-7133-1111
Email yosmatsu@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Matsumoto
Organization National Cancer Center Hospital East
Division name Department of Palliative Medicine
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL +81-4-7133-1111
Homepage URL
Email yosmatsu@east.ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 16 Day
Last follow-up date
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
2017 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029335

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.