UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012772
Receipt number R000014920
Scientific Title Early specialty palliative care for patients with advanced lung cancer undergoing chemotherapy: Feasbility study
Date of disclosure of the study information 2014/01/07
Last modified on 2024/01/10 16:21:15

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Basic information

Public title

Early specialty palliative care for patients with advanced lung cancer undergoing chemotherapy: Feasbility study

Acronym

Early specialty palliative care for patients with advanced lung cancer undergoing chemotherapy: Feasbility study

Scientific Title

Early specialty palliative care for patients with advanced lung cancer undergoing chemotherapy: Feasbility study

Scientific Title:Acronym

Early specialty palliative care for patients with advanced lung cancer undergoing chemotherapy: Feasbility study

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 feasibility of specialty palliative care comprehensive program for hospitalized patients with advanced lung cancer undergoing first-line chemotherapy.

Basic objectives2

Others

Basic objectives -Others

Feasibility

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Completion rate of the questionnaires after second course of first-line chemotherapy

Key secondary outcomes

(1) Functional Assessment of Cancer Therapy-Lung(FACT-L)
(2) Patient Health Questionnaire 9(PHQ-9)
(3) Hospital Anxiety and Depression Scale(HADS)
(4) Rate of the patients received intervention of specialty palliative care service
(5) Contents of intervention performed by specialty palliative care service


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Other

Interventions/Control_1

Patients with advanced lung cancer undergoing first-line platinum-based chemotherapy in hospital receive specialty 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-centered interdisciplinary approach.

Interventions/Control_2


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 stage IV non-small cell lung cancer or extended-disease small cell lung cancer.
(2) undergoing first-line platinum-based chemotherapy in hospital at National Cancer Hospital East.
(3) informed about the cancer by the physician.
(4) age >= 20 years.
(5) expected to survive for more than 3 months.

Key exclusion criteria

(1) recurrence after surgery for lung cancer.
(2) with severe cognitive impairment.
(3) already consulted outpatient palliative medicine clinic or outpatient psyco-oncology clinic before entry to this study.
(4) already received intervention of specialty palliative care service before diagnosis.
(5) participate in other intervention studies which prohibit participation in this study.
(6) unable to read and respond to questions in Japanese.
(7) judged to be inappropriate for participation to this study by the attending physician.

Target sample size

47


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

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

TEL

+81-4-7133-1111

Homepage URL


Email

yosmatsu@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://academic.oup.com/jjco/article/52/4/375/6515542?login=true

Number of participants that the trial has enrolled

50

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

Completed

Date of protocol fixation

2012 Year 05 Month 26 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 06 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

2014 Year 01 Month 07 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=R000014920


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name