UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036147 |
|---|---|
| Receipt number | R000041098 |
| Scientific Title | The prospective interventional study with a newly-supplied booklet for "working to be able to balance work with cancer" on the employment support program for cancer patients |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2020/03/10 09:21:32 |
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Basic information
Public title
The prospective interventional study with a newly-supplied booklet for "working to be able to balance work with cancer" on the employment support program for cancer patients
Acronym
Employment support program with a newly-supplied booklet for patients with cancer (ESPOIR)
Scientific Title
The prospective interventional study with a newly-supplied booklet for "working to be able to balance work with cancer" on the employment support program for cancer patients
Scientific Title:Acronym
Employment support program with a newly-supplied booklet for patients with cancer (ESPOIR)
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical utility of the interventional support with a newly-supplied booklet by Oncology Medical Social Worker as the employment support program for cancer patients, in comparison with the historical control data, which was made on the basis of the previous prospective cohort study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
rate of turnover
Key secondary outcomes
(1) rate of continuous employment, timing of turnover decision
(2) EORTC QLQ-C30 Score
(3) SEAC Score
(4) Answer proportion of items regarding employment supports
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1)the interventional support by Oncology Medical Social Worker as the employment support program for cancer patients
2)case management by with a newly-supplied booklet for "working to be able to balance work with cancer"
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)The first visit patients with cancer or cancer suspicious lesion
(2)Age: 20-65 years old
(3)Patient who has a cancer or cancer suspicious lesion, and would like to undergo the initial treatment at that hospital
(4)Patient who receives a reward of his work at that time of his/her suspicion of malignancy
(5)Written informed consent
Key exclusion criteria
(1)Patients without their reservations of outpatient clinic after their first visits to hospital
(2) Patients with obvious impairment of consciousness
(3) Patients with severe or uncontrolled systemic disease
(4) Patients who is not able to understand this study because of dementia, delirium, depression or other cognitive disorder
(5) Patients who were uncapable of understanding spoken and written Japanese
(6) Patient is judged by the investigator to be inappropriate for study participation for any reason
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hatoe Sakamoto |
Organization
National Cancer Center Hospital East
Division name
Supportive Care Center
Zip code
Address
6-5-1 Kashiwanoha,Kashiwa-shi,Chiba, 277-8577 Japan
TEL
04-7133-1111
hasakamo@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hatoe Sakamoto |
Organization
National Cancer Center Hospital East
Division name
Supportive Care Center
Zip code
Address
6-5-1 Kashiwanoha,Kashiwa-shi,Chiba, 277-8577 Japan
TEL
04-7133-1111
Homepage URL
hasakamo@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
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
Address
Tel
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
国立がん研究センター東病院（千葉県）、国立がん研究センター中央病院（東京都）、虎の門病院（東京都）、北里大学病院（神奈川県）、長野市民病院（長野県）、福井県済生会病院（福井県）、兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 10 | Day |
Last modified on
| 2020 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041098
