UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059120 |
|---|---|
| Receipt number | R000067622 |
| Scientific Title | Exploratory study on comprehensive perioperative interventions to promote postoperative physical activity in colorectal cancer patients |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/09/18 11:57:33 |
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Basic information
Public title
Study to promote postoperative physical activity in colorectal cancer patients
Acronym
Study on postoperative physical activity in colorectal cancer patients
Scientific Title
Exploratory study on comprehensive perioperative interventions to promote postoperative physical activity in colorectal cancer patients
Scientific Title:Acronym
Intervention study on perioperative physical activity in colorectal cancer patients
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. To implement a comprehensive intervention for colorectal cancer patients undergoing surgery, consisting of nurse-led physical activity guidance, goal setting, and self-monitoring, aimed at promoting postoperative physical activity, and to evaluate changes in physical activity at 3 months and 6 months after surgery.
2. To explore and quantitatively assess the effects of the intervention by referencing data from participants in previous observational studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity (Number of steps)
Key secondary outcomes
Physical activity(moderate to vigorous intensity)
Quality of Life(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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nurse-led physical activity guidance
Individualized goal setting for physical activity
Self-monitoring using wearable device
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
Male and Female
Key inclusion criteria
1.Patients undergoing colorectal cancer resection at Kyushu University Hospital
2.Patients aged 18 years or older at the time of obtaining consent
3.Patients who fully understand the study protocol and are capable of providing informed consent
4.Patients who provide written informed consent
5.Patients who have lived at home for at least four days prior to the day of hospital admission for surgery
Key exclusion criteria
1.Patients unable to complete a self-administered questionnaire in Japanese
2.Patients with limitations in physical activity or difficulty performing activities due to treatment or comorbidities
3.Patients who do not have a device capable of downloading the Fitbit app
4.Patients whom the attending physician judges as unsuitable for study participation due to severe comorbidities or complications
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Satomi |
| Middle name | |
| Last name | Tanaka |
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
092-642-6917
tanaka.satomi.198@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Tanaka |
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
092-642-6917
Homepage URL
tanaka.satomi.198@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Satomi Tanaka
Funding Source
Organization
Japan Society for the Promotion of Science
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 06 | 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 | 09 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2030 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067622
