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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012772
Receipt No. 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 2016/12/31

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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
Institute National Cancer Center Hospital East
Institute
Department

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 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 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
2016 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.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


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