UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056511 |
|---|---|
| Receipt number | R000064581 |
| Scientific Title | Changes in physical activity in colorectal cancer patients during 6 months of postoperative adjuvant chemotherapy in relation to patient background factors. |
| Date of disclosure of the study information | 2024/12/21 |
| Last modified on | 2024/12/20 12:28:44 |
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Basic information
Public title
Changes in physical activity in colorectal cancer patients during 6 months of postoperative adjuvant chemotherapy in relation to patient background factors.
Acronym
Changes in physical activity in colorectal cancer patients during 6 months of postoperative adjuvant chemotherapy in relation to patient background factors.
Scientific Title
Changes in physical activity in colorectal cancer patients during 6 months of postoperative adjuvant chemotherapy in relation to patient background factors.
Scientific Title:Acronym
Changes in physical activity in colorectal cancer patients during 6 months of postoperative adjuvant chemotherapy in relation to patient background factors.
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine changes in factors affecting physical activity in colorectal cancer patients during 6 months of postoperative adjuvant chemotherapy and their association with patient background factors
Basic objectives2
Others
Basic objectives -Others
To determine changes in physical activity of colorectal cancer patients before surgery and at 4 time points during 6 months of adjuvant chemotherapy (first day of the first course, end of the second course, end of the fourth course (3 months later), and end of the eighth course (6 months later)), for a total of 5 time points.
To determine the association between physical activity and background factors of physical activity at 4 time points during the 6 months of postoperative adjuvant chemotherapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
International Physical Activity Questionnaire
Key secondary outcomes
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Two to three facilities that perform colorectal cancer surgery and have a certified cancer chemotherapy nurse dedicated to the outpatient chemotherapy unit will be considered eligible facilities.
R0 resection (curative resection) of colorectal cancer was performed.
Postoperative histology results are Stage II, III, or IV.
Patient is under 75 years of age.
ECOG (American Oncology Group) PS (Performance Status) is 0.
Key exclusion criteria
a. cardiovascular disease (cardiac/coronary artery disease under treatment and poorly controlled hypertension) that requires limitation of physical activity
Bone/joint disease or chronic respiratory disease that limits physical activity. c. Previous cancer chemotherapy.
Previous cancer chemotherapy.
Difficulty in completing the questionnaire due to cognitive decline.
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Kanae |
| Middle name | |
| Last name | Suzuki |
Organization
Japanese Red Cross Hiroshima College of Nursing
Division name
School of Nursing
Zip code
738-0052
Address
1-2, Ajindaihigashi, Hatsukaichi City, Hiroshima Prefecture
TEL
0829-20-2800
ks11121@jrchcn.ac.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Suzuki |
Organization
Japanese Red Cross Hiroshima College of Nursing
Division name
School of Nursing
Zip code
738-0052
Address
1-2, Ajindaihigashi, Hatsukaichi City, Hiroshima Prefecture
TEL
0829-20-2800
Homepage URL
ks11121@jrchcn.ac.jp
Sponsor or person
Institute
Japanese Red Cross Hiroshima College of Nursing
Institute
Department
Personal name
Funding Source
Organization
without
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Hiroshima College of Nursing
Address
1-2, Ajindaihigashi, Hatsukaichi City, Hiroshima Prefecture
Tel
0829-20-2800
ks11121@jrchcn.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
| 2024 | Year | 12 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Changes in Physical Activity (IPAQ) in Colorectal Cancer Patients Receiving Postoperative Adjuvant Chemotherapy
Association between physical activity (IPAQ) and background factors (cancer-related fatigue, chemotherapy-induced peripheral neuropathy, hand-foot syndrome, etc.) in colorectal cancer patients undergoing postoperative adjuvant chemotherapy
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064581
