UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060457 |
|---|---|
| Receipt number | R000069135 |
| Scientific Title | Effectiveness evaluation of a remote training program to strengthen interdisciplinary collaboration between labor and social security attorneys and occupational health nurses in supporting treatment-work balance in small and medium-sized enterprises. |
| Date of disclosure of the study information | 2026/01/24 |
| Last modified on | 2026/01/24 20:14:33 |
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Basic information
Public title
Effectiveness evaluation of a remote training program to strengthen interdisciplinary collaboration between labor and social security attorneys and occupational health nurses in supporting treatment-work balance in small and medium-sized enterprises.
Acronym
Effectiveness evaluation of a remote training program for treatment-work balance support in small and medium-sized enterprises
Scientific Title
Effectiveness evaluation of a remote training program to strengthen interdisciplinary collaboration between labor and social security attorneys and occupational health nurses in supporting treatment-work balance in small and medium-sized enterprises.
Scientific Title:Acronym
Effectiveness evaluation of a remote training program for treatment-work balance support in small and medium-sized enterprises
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the effectiveness of a training program designed for labor and social security attorneys (LSSAs) and occupational health nurses (OHNs) to collaborate in treatment-work balance support in small and medium-sized enterprises.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome measure: increase in factor score for confidence in collaboration (endpoint value minus baseline value).
Key secondary outcomes
Secondary Outcome: Increase in item scores regarding understanding of other professionals' strengths (endpoint value minus baseline value).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention:
The intervention group received a 140-minute online training program via Zoom. The program consisted of the following components: (1) case study introduction using original manga videos depicting a small company's experience supporting an employee with cancer (approximately X minutes); (2) two group work sessions where 3-4 participants (mixed LSSAs and OHNs) discussed collaboration strategies using breakout rooms (20 and 30 minutes, respectively); (3) plenary discussions where each group shared their worksheets (20 and 15 minutes); and (4) information sharing by researchers on their research findings (15 minutes). Researchers served as facilitators and recorders for each group. The detailed time schedule is shown in Table 1, and the manga story overview is provided in the Supplementary Materials.
Control:
The control group was assigned to a waiting list and received no intervention during the study period. They continued their usual professional activities.
Interventions/Control_2
After the endpoint survey was completed, they received the same training program as the intervention group.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Selection criteria were set as having less than 3 years of experience supporting treatment-work balance in SMEs and having no prior collaboration experience between the two professions
Key exclusion criteria
(1) inability to participate in the scheduled online training sessions, and (2) incomplete baseline questionnaire responses.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Shimamoto |
Organization
Tokai university
Division name
School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
0463-93-1121
s_shimamoto@tsc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Abe |
Organization
Tokai university
Division name
Graduate School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
sweetmaromaro0301@gmail.com
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University School of Medicine Clinical Research Review Committee
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
Tel
0463-93-1121
tokai-rec@tokai.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
| 2026 | Year | 01 | Month | 24 | 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
79
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
| 2023 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2026 | Year | 01 | Month | 24 | Day |
Last modified on
| 2026 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069135
