UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035437 |
|---|---|
| Receipt number | R000040370 |
| Scientific Title | A multi-institutional prospective cohort study of employment after colorectal cancer surgery |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2023/03/29 12:53:21 |
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Basic information
Public title
A multi-institutional prospective cohort study of employment after colorectal cancer surgery
Acronym
A multi-institutional prospective cohort study of employment after colorectal cancer surgery
Scientific Title
A multi-institutional prospective cohort study of employment after colorectal cancer surgery
Scientific Title:Acronym
A multi-institutional prospective cohort study of employment after colorectal cancer surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our study aims are 1: to clarify the proportion of working patient and 2: to explore risk factors for returning to work, one year after surgery.
Basic objectives2
Others
Basic objectives -Others
To estimate proportion
To explore risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of working patients one year after surgery
Key secondary outcomes
1) Time from surgery to returning to work
2) Proportion of employed patients one year after surgery
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) cStage I, II, or III colorectal cancer
2) planning curative surgery
3) employed at the time of diagnosis
4) obtained consent by the document
Key exclusion criteria
1) undergoing chemotherapy for other cancers
2) judged inappropriate by the examining doctor
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Obama |
Organization
Kyoto University
Division name
Gastrointestinal surgery
Zip code
6068507
Address
54, Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
kobama@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Fujita |
Organization
Kyoto University
Division name
Gastrointestinal surgery
Zip code
6068507
Address
54, Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
Homepage URL
0424.yusuke@gmail.com
Sponsor or person
Institute
Department of Gastrointestinal Surgery, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
The Mitsubishi foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address
54, Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2019 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
130
Results
The median time to return to work was 1.1 months, and the proportion of working patients at 12 months after surgery was 79%.
Results date posted
| 2023 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 129 patients, 50 (39%) were over 65 years, 46 (36%) were female, and 62 (48%) had rectal cancer. There were 48 patients (37%) with clinical stage III CRC and 126 (98%) who received minimally invasive surgery. Six patients (5%) received preoperative radiation. However, all of these patients were also included in the group of nine patients (7%) who received preoperative chemotherapy. Stoma was created for 31 patients (24%). Postoperative overall complications were observed in 27 patients (21%). In addition, 50 patients (39%) underwent adjuvant chemotherapy. A total of 45 patients (35%) were regular employees, 43 (33%) were non-regular employees, and 40 (31%) were self-employed. Seventy-two patients (56%) worked in companies with 50 or fewer employees. Finally, most patients (89%) were willing to RTW.
Participant flow
One patient was excluded after enrollment as they were diagnosed with ovarian cancer, not CRC, during surgery. Accordingly, 129 patients were included in the analyses.
The questionnaire was used to follow up on 128 patients (99%) at six months and 125 patients (97%) at 12 months.
Adverse events
None
Outcome measures
The time it takes patients to return to work after surgery and the proportion of working patients 12 months after surgery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 21 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We estimate the proportion of working patients one year after surgery. We estimate the proportion of employed patients in the same way. We estimate the time from surgery to returning to work with the Kaplan-Meier method.
We explore the influence of clinical factors and socioeconomic factors on returning to work by estimating their risk ratio and odds ratio. In particular, when we explore the effects of adjuvant chemotherapy, we focus on patients with pStageII, III.
Management information
Registered date
| 2019 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040370
