UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008373 |
|---|---|
| Receipt number | R000009463 |
| Scientific Title | Development of Cancer Specific Geriatric Assessment (CSGA) for cancer patients in Japan. |
| Date of disclosure of the study information | 2012/07/07 |
| Last modified on | 2013/08/13 12:54:36 |
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Basic information
Public title
Development of Cancer Specific Geriatric Assessment (CSGA) for cancer patients in Japan.
Acronym
Feasibility study of CSGA in Japan.
Scientific Title
Development of Cancer Specific Geriatric Assessment (CSGA) for cancer patients in Japan.
Scientific Title:Acronym
Feasibility study of CSGA in Japan.
Region
| Japan |
Condition
Condition
Cancer patients
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Geriatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
feasibility
Basic objectives2
Others
Basic objectives -Others
1.rate of completion without assistance
2.time to completion
3.understandability of questionnaire
4.understandability of answer
5.the number of questions hard to answer without assistance
6.questionnaire hard to answer and the reasons for incompletions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.rate of completion without assistance
2.time to completion
3.understandability of questionnaire
4.understandability of answer
5.the number of questions hard to answer without assistance
6.questionnaire hard to answer and the reasons for incompletions
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Complete the CSGA
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must have cancer that has been histologically or cytologically confirmed.
Age >= 65 years
Ability to complete questionnaire(s) by themselves or with assistance.
Provide informed written consent.
Key exclusion criteria
Medical, social or psychological factors which would interfere with consent and
follow up
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Nagashima |
Organization
Kyorin University
Division name
Division of Medical Oncology
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cancer Center Hospital East
Division name
Division of Psyco-oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577
TEL
Homepage URL
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | 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
| 2012 | Year | 07 | Month | 07 | Day |
Last modified on
| 2013 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009463
