UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048880 |
|---|---|
| Receipt number | R000055700 |
| Scientific Title | Return to work and work sustainability among patients after surgery for gastric and esophageal cancer |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2026/08/24 22:11:34 |
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Basic information
Public title
Return to work and work sustainability among patients after surgery for gastric and esophageal cancer
Acronym
Return to work and work sustainability among patients after surgery for gastric and esophageal cancer
Scientific Title
Return to work and work sustainability among patients after surgery for gastric and esophageal cancer
Scientific Title:Acronym
Return to work and work sustainability among patients after surgery for gastric and esophageal cancer
Region
| Japan |
Condition
Condition
Gastric and esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are 1:to investigate the return to work status of patients who have undergone radical gastric or esophageal cancer surgery and the factors that hinder their return to work, and 2: to obtain information that will contribute to the identification of patients who need postoperative support, including employment.
Basic objectives2
Others
Basic objectives -Others
Investigate risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of working patients at work 1.5 years after surgery
Key secondary outcomes
1)The Proportion of employed patients 1.5 years after surgery
2)Time taken to return to work 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)Clinical stage I-IVA gastric or esophageal cancer without distant metastasis
2)Planning curative surgery
3)Employed at the time of diagnosis
4)Obtained consent by the document
Key exclusion criteria
1)Scheduled for treatment of other cancers from the diagnosis of gastric cancer or esophageal cancer to admission before surgery
2)Emergency surgery cases
3)Bypass, local resection, transhiatal esophagectomy, esophagectomy with two-stage reconstruction or planned two-stage reconstruction, salvage surgery
4)With psychiatric symptoms that make it difficult for them to participate in the study
Target sample size
200
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
606-8397
Address
54, Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3650
kobama@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Ueno |
Organization
Kyoto University
Division name
Gastrointestinal surgery
Zip code
606-8397
Address
54, Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
Homepage URL
k_ueno@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
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
Osaka Red Cross Hospital
Kyoto Medical Center
Kyoto Katsura Hospital
Kobe City Medical Center West Hospital
Japanese Red Cross Wakayama Medical Center
Japan Baptist hospital
Kyoto City Hospital
Tenri Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-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
京都大学医学部附属病院(京都府)、大阪赤十字病院(大阪府)、京都医療センター(京都府)、
京都桂病院(京都府)、神戸市立医療センター西市民病院(兵庫県)、
日本赤十字社和歌山医療センター(和歌山県)、日本バプテスト病院(京都府)、
京都市立病院(京都府)、天理よろづ相談所病院(奈良県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/ags3.70251
Number of participants that the trial has enrolled
167
Results
Among 158 eligible patients, 124 (78.5%) were working at 18 months. Older age and pathological stage III or more were associated with non-working at 18 months, whereas sedentary work and self-employment were associated with a lower risk of non-working. Postoperative appetite loss, financial difficulties (QLQ-C30), and 10% or more body weight loss at 6 months were associated with non-working status. Median time to first RTW was 30 and 70 days for gastric and esophageal cancers, respectively.
Results date posted
| 2026 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 07 | Month | 26 | Day |
Baseline Characteristics
The median age was 65.5 years (range: 37-84 years), and 152 (96.2%) patients achieved R0 resection. Pathological stage III or more disease was observed in approximately 30% patients. Postoperative complications were observed in 45 (28.5%) patients. More than 90% of the patients underwent minimally invasive surgery. Preoperative retirement was observed in seven (4.4%) patients, 55 (34.8%) patients were self-employed, 54 (34.2%) were regular employees, and 96 (60.8%) worked in companies or offices with 50 or fewer employees.
Participant flow
Overall, 167 patients were initially enrolled in this study, following the exclusion of 5. Two patients were excluded because they withdrew before postoperative assessment. In addition, patients who lacked willingness to RTW preoperatively (n = 1) and those who had missing critical outcome data (n = 1) were excluded from the analysis. A total of 158 patients were finally included in the analysis.
Adverse events
N/A
Outcome measures
The primary endpoint in this study was the proportion of patients who were working at 18 months post-surgery.
Secondary endpoints were the proportion of employed patients 18 months post-surgery (including those on sick leave) and time to return-to-work.
Plan to share IPD
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
The primary endpoint is the proportion of patients who are working at 1.5 years postoperatively.
Management information
Registered date
| 2022 | Year | 09 | Month | 08 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055700
