UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046930 |
|---|---|
| Receipt number | R000053536 |
| Scientific Title | Study on working and daily activities affected by quality of life in colorectal patients/ |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/10/08 11:59:37 |
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Basic information
Public title
Study on working and daily activities affected by quality of life in colorectal patients
Acronym
Study on working and daily activities affected by quality of life in colorectal patients/
Scientific Title
Study on working and daily activities affected by quality of life in colorectal patients/
Scientific Title:Acronym
Study on working and daily activities affected by quality of life in colorectal patients/
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of changes in QOL (general state of cancer, fatigue, etc.) and self-efficacy on ability to work and perform regular activities in colorectal cancer patients.
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of changes in QOL and self-efficacy on ability to work and perform regular activities in colorectal cancer patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL assessment, self-efficacy assessment, assessment of work productivity and activity impairment, and assessment of employment activities
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The enrolled patients meet the following selection criteria: 1) are >=20 years and <=80 years of age; 2) confirmed case of resectable primary colorectal cancer (except for appendix cancer and anal canal cancer); 3) have performance status (ECOG scale of 0 or 1); and 4) have provided written informed consent for participating in the study.
Key exclusion criteria
The exclusion criteria were as follows: 1) history of allergy to drug; 2) presence of serious complications (e.g., hepatic, renal, cardiac, hematologic, or metabolic diseases); 3) lactation, pregnancy, or planned pregnancy during the study or follow-up period; 4) Patients with synchronous multiple primary cancers; and 5) considered ineligible to participate by the chief investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akinobu |
| Middle name | |
| Last name | Taketomi |
Organization
Hokkaido University, Graduate School of Medicine
Division name
Department of Gastroenterological Surgery I
Zip code
0608638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Yoshida |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterological Surgery I
Zip code
0608648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5927
Homepage URL
ta73825@dg7.so-net.ne.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study: All patients with resectable primary colorectal cancer at Hokkaido University between January 28th in 2022 and March 31st in 2024.
Management information
Registered date
| 2022 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053536
