UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictive factors for psychological distress related to treat esophageal cancer
Title of the study (Brief title)	Predictive factors for psychological distress related to treat esophageal cancer
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The evaluation of the psychological distress and QOL related to treat esophageal cancer
Basic objectives2	Others
Basic objectives -Others	Predictive factors for psychological distress related to treat esophageal cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	psychological distress 1. HADS: Hospital anxiety and depression scale 2. EORTC QLQ-C30/ OES18: European Organization for Research and Treatment of Cancer QLQ C-30/ OES18
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1. Esophageal cancer patients underwent esophagectomy 2. Pt. aged 20 to 85 years 3. Performance status 0-2 4. Written informed consent 5. Pt. with notification of their cancer disease
Key exclusion criteria	1. No informed consent is obtained 2. Pt. with a history of severe cognitive impairment and mental disorder 3. Pt. who have judged by doctor or nurse not to be suitable for this study participation because of psycological and physical stress. 4. Pt. who have judged by doctor or nurse not to be suitable for this study participation 5. Pt. didn't hope for an operation 6. Pt. without esophagectomy
Target sample size	120

Research contact person
Name of lead principal investigator	Eisuke Matsushima
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Section Division of Liaison Psychiatry and Palliative Medicine
Address	1-5-45, yushima, bunkyo-ku, tokyo
TEL	03-3803-5859
Email	em.lppm@tmd.ac.jp

Public contact
Name of contact person	Yu Ohkura
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental
Division name	Section Division of Liaison Psychiatry and Palliative Medicine
Address	1-5-45, yushima, bunkyo-ku, tokyo
TEL	03-3803-5859
Homepage URL
Email	yu.ohkura107@gmail.com

Sponsor
Institute	Toranomon Hospital
Institute
Department

Funding Source
Organization	Toranomon Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 09 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 25 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2017 Year 09 Month 08 Day
Last modified on	2017 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033229