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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002138
Receipt No. R000002609
Scientific Title Quality of life measurement in cancer patients receiving intervention of palliative care team
Date of disclosure of the study information 2009/10/01
Last modified on 2010/05/12

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Basic information
Public title Quality of life measurement in cancer patients receiving intervention of palliative care team
Acronym QOL measurement receiving PCT
Scientific Title Quality of life measurement in cancer patients receiving intervention of palliative care team
Scientific Title:Acronym QOL measurement receiving PCT
Region
Japan

Condition
Condition cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aims of study are 1) to identify sympton prevalence and intensity in cancer patients and 2) to describe longitudinal follow-up data obtained from repeated assessment using EORTC-C30
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1) the number of patients referred to the palliative care team after treating physicians recongnized patients needs via the screening quesionnaire.
2) the score of EORTC-C30 receiving intervention of palliative care team
Key secondary outcomes

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
Interventions/Control_1 palliative care
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Eligible patients have malignant tumor, are at least 18 years old, and are well enough and have sufficient Japanease proficiency to provide informed consent and complete questionnaires.
Key exclusion criteria Nonqualified patients are not enough and do not have sufficient Japanease proficiency to provide informed consent and complete questionnaires.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Sakashita
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address
TEL 078-382-5846
Homepage URL
Email

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 10 Month 01 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
2009 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 29 Day
Last modified on
2010 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002609

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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