UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048509 |
|---|---|
| Receipt number | R000055281 |
| Scientific Title | Exercise Behavior in older adults with cancer receiving comprehensive geriatric assessment (CGA) |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/07/29 10:49:04 |
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Basic information
Public title
Exercise Behavior in older adults with cancer receiving comprehensive geriatric assessment (CGA)
Acronym
EB in OAC s/p CGA
Scientific Title
Exercise Behavior in older adults with cancer receiving comprehensive geriatric assessment (CGA)
Scientific Title:Acronym
EB in OAC s/p CGA
Region
| Japan |
Condition
Condition
Malignant Neoplasm
Classification by specialty
| Hematology and clinical oncology | Geriatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively assess Exercise Behavior in older adults with cancer who receive CGA at geriatric oncology service.
Basic objectives2
Others
Basic objectives -Others
To explore factors that impact Exercise Behavior
To evaluate association between Exercise Behavior and outcomes
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exercise Behavior at 3 months and 6 months after a CGA
Key secondary outcomes
Self-efficacy
Falls
Fractures
Survival
Adverse events
Patterns of treatment and care
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cancer who receive CGA at geriatric oncology service.
Able to comprehend Japanese and answer questionnaires by themselves with and without support from their caregiver(s).
Key exclusion criteria
NA
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | F |
| Last name | Nishijima |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Geriatric Oncology Service
Zip code
811-1347
Address
3 Chome-1-1 Notame, Minami Ward, Fukuoka, Fukuoka Prefecture
TEL
092-541-3231
nishijima.tomohiro.zg@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | F |
| Last name | Nishijima |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Geriatric Oncology Service
Zip code
811-1347
Address
3 Chome-1-1 Notame, Minami Ward, Fukuoka, Fukuoka Prefecture
TEL
092-541-3231
Homepage URL
nishijima.tomohiro.zg@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Cancer Center
Address
3 Chome-1-1 Notame, Minami Ward, Fukuoka, Fukuoka Prefecture
Tel
092-541-3231
hirata.yoshiyuki.dk@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055281
| 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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| Registered date | File name |
