UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002138 |
|---|---|
| Receipt number | 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 13:24:59 |
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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
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
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002609
