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

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 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


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

Value
https://center6.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