UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055458 |
|---|---|
| Receipt number | R000063371 |
| Scientific Title | A prospective exploratory study investigating the longitudinal changes in physical activity among patients undergoing radical hysterectomy for endometrial cancer |
| Date of disclosure of the study information | 2024/09/08 |
| Last modified on | 2025/09/08 23:31:11 |
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Basic information
Public title
A prospective exploratory study investigating the longitudinal changes in physical activity among patients undergoing radical hysterectomy for endometrial cancer
Acronym
A prospective exploratory study of physical activity in patients undergoing radical endometrial cancer
Scientific Title
A prospective exploratory study investigating the longitudinal changes in physical activity among patients undergoing radical hysterectomy for endometrial cancer
Scientific Title:Acronym
A prospective exploratory study of physical activity in patients undergoing radical endometrial cancer
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to explore changes in physical activity and physical function over time from postoperative to 6 months after surgery for endometrial cancer patients and to clarify factors related to physical activity.
Basic objectives2
Others
Basic objectives -Others
To examine change in physical activity and physical function from immediate post-discharge to 6 months post-surgery with endometrial cancer. To assess physical activity using wearable devise (OMRON Active style Pro 750C), and using grip strength and Sit to Stand=5 for physical function. To clarify the factors associated with physical activity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation period: Postoperative, 6 months postoperative
Outcome: steps per day
Key secondary outcomes
Evaluation period:
Postoperative, 6 months postoperative,
Outcomes:
1:Grip strength
2:Sit to Stand-5
3:Health-related quality of life scale (The European Organization for Research and Treatment of Cancer QLQ-C30)
4:Ovarian deficiency symptom scale (the Keio Questionnaire)
5:Physical activity scale (international standardized physical activity questionnaire)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventional period: Postoperative, 6 months postoperative
Intervention: To wear a wearable device (OMRON Active style Pro 750C) on clothing for more than a week.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1:Cases pathologically diagnosed with endometrial cancer
2:From the date of approval by the Ethics Committee, patients who underwent surgery including total hysterectomy + bilateral adnexectomy as the initial treatment for endometrial cancer at Keio University Hospital Gynecology
3:Cases over 20 years old
4:Cases with a preoperative performance status of 0
5:Cases that can be explained and understood in writing and signed with consent
6:Be able to prepare a smartphone and an email address.
Key exclusion criteria
1:Cases with active double cancer
2:Cases with a history of cancer within 5 years other than carcinoma in situ
3:Cases with a history of serious mental illness or complications
4:Cases with a history of limb deficiency (congenital or acquired), cerebrovascular disease, and progressive neuromuscular disease.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University school of medicine
Division name
Rehabilitation medicine
Zip code
160-0016
Address
35 shinanomachi shinjyuku-ku Tokyo, Japan
TEL
03-5363-3833
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Kiriko |
| Middle name | |
| Last name | Abe |
Organization
Keio University school of medicine
Division name
Rehabilitation medicine
Zip code
160-0016
Address
35 shinanomachi shinjyuku-ku Tokyo, Japan
TEL
03-5363-3833
Homepage URL
kiriko916@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Faculty of Medicine Ethics Committee
Address
35 shinanomachi shinjyuku-ku Tokyo, Japan
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（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 08 | 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
| 2024 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 08 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063371
