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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048509
Receipt No. 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

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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
Email 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
Email nishijima.tomohiro.zg@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Kyushu Cancer Center
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055281

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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