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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036147
Receipt No. 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 2019/03/10

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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 Obsterics 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
Email 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
Email hasakamo@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 04 Day
Last follow-up date
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
2019 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041098

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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