UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041098