UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058235 |
|---|---|
| Receipt number | R000066577 |
| Scientific Title | Evaluation of a multimodal intervention to promote physical activity in patients undergoing surgical resection of female genital tract tumors |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/20 12:39:16 |
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Basic information
Public title
A study of multimodal support efficacy in enhancing physical activity in patients undergoing gynecologic surgery
Acronym
A study of multimodal support efficacy in enhancing physical activity in patients undergoing gynecologic surgery
Scientific Title
Evaluation of a multimodal intervention to promote physical activity in patients undergoing surgical resection of female genital tract tumors
Scientific Title:Acronym
Evaluation of a multimodal intervention to promote physical activity in patients undergoing surgical resection of female genital tract tumors
Region
| Japan |
Condition
Condition
female genital tract tumors
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will be performed to clarify the impact of an intervention that combines self-monitoring using an activity tracker with discharge guidance on longitudinal changes in physical activity among patients undergoing surgical resection of gynecologic tumors. By organizing step count data from the control group and the self-monitoring-only reference group, we will also exploratorily assess the proportion of individuals in each group who meet the guideline-recommended step count (6,000 steps/day) to examine the efficacy of the intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of steps
Key secondary outcomes
Moderate to vigorous activity time, QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
(1) Discharge Guidance
(2) Wearing an active tracker (Fitbit)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Patients diagnosed with cervical cancer, endometrial cancer, ovarian cancer, or suspected of having these conditions who are undergoing surgery
(2) Patients who can independently give consent
(3) Patients at least 18 years of age
Key exclusion criteria
(1) Patients who do not have a device capable of installing the activity tracker application
(2) Patients with impaired motor function
(3) Patients with cognitive impairment
(4) Patients judged to be inappropriate for clinical practice by researcher or physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kimie |
| Middle name | |
| Last name | Fujita |
Organization
Kyushu University
Division name
Nursing Couse Department of Health Sciences Faculty of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6738
fujita.kimie.874@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Mina |
| Middle name | |
| Last name | Matsumura |
Organization
Kyushu University
Division name
Department of Health Sciences, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6738
Homepage URL
matsumura.mina.466@s.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Japan
Yamaji Fumiko Public Trust Fund for Advanced Nursing Education and Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical and Translational Research(CCTR) of Kyushu University Hospital
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5774
tr-info@med.kyushu-u.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
九州大学病院 / Kyushu University Hospital
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2025 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066577
