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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name