UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036795 |
|---|---|
| Receipt number | R000041927 |
| Scientific Title | Relation of frailty and quality of life in continuing treatment of elderly gastroenterological cancer patient |
| Date of disclosure of the study information | 2019/06/12 |
| Last modified on | 2020/05/25 16:53:11 |
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Basic information
Public title
Relation of frailty and quality of life in continuing treatment of elderly gastroenterological cancer patient
Acronym
Relation of frailty and quality of life in continuing treatment of elderly gastroenterological cancer patient
Scientific Title
Relation of frailty and quality of life in continuing treatment of elderly gastroenterological cancer patient
Scientific Title:Acronym
Relation of frailty and quality of life in continuing treatment of elderly gastroenterological cancer patient
Region
| Japan |
Condition
Condition
gastroenterological cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between frailty and quality of life when changing chemotherapy regimens for patients with gastroenterological cancer
Basic objectives2
Others
Basic objectives -Others
The relationships between Frailty, QOL,and Chemotherapy Adverse Events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty State, Geriatric 8 (G8) Score
Key secondary outcomes
(1) Degree of adverse events Measure with PRO-CTCAE
(2) QOL degree EQ-D5-L5 score
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
(1) Elderly person 65 years of age or more
(2) Patients with stage II to stage IV gastroenterological cancer
(stomach, colon, pancreas, biliary tract cancer etc.)
(3) Patient who have changed the currently received regimen and have started a new regimen
(4) Patient who is judged by primary doctor determines that investigation cooperation is possible physically and mentally
(5) Patient who gained consent to participate in research
Key exclusion criteria
(1) Patient shall not have dementia or its previous history
(2) Those who cannot understand Japanese to complete the questionnaire
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Komatsu |
Organization
Keio University Graduate School of Health Management
Division name
Nursing
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL
03-5363-3733
komah@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Oohinata |
Organization
Keio University Graduate School of Health Management
Division name
Nursing
Zip code
252-0883
Address
4411 Endo, Fujisawa-shi, Kanagawa 252-0883
TEL
0466-49-6265
Homepage URL
h18704ho@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University Graduate School of Health Management
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Design: Observational cross-sectional study
Measures
1)Status of residence
2)Instrumental Activities of Daily Living
3)Degree of adverse events of chemotherapy
4)Quality of life
5)Charlson Comorbidity Index
6)Frailty index
7)Measurement of the calf
Management information
Registered date
| 2019 | Year | 05 | Month | 20 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041927
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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