UMIN-CTR Clinical Trial

Basic information
Public title	Effect verification of interventing by "The Guidebook for Stress management about the Promotion of Health and Employment Support"
Acronym	Intervention of psychoeducation for stress management about the Promotion of Health and Employment Support
Scientific Title	Effect verification of interventing by "The Guidebook for Stress management about the Promotion of Health and Employment Support"
Scientific Title:Acronym	Intervention of psychoeducation for stress management about the Promotion of Health and Employment Support
Region	Japan

Condition
Condition	Cancer (gastric cancer, colon cancer, esophageal cancer, lung cancer, breast cancer, cervical cancer, liver cancer), stroke, angina, myocardial infarction, valvular heart disease, aortic aneurysm, arteriosclerosis obliterans, chronic organ failure (renal failure, Liver failure, heart failure)
Classification by specialty	Medicine in general Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Against the background of the growing need for support for balancing work life and treatment, the "Stress Management Guidebook for Balance Support" created last year and its website are used, and information such as how to practice stress management is used as a psychoeducation program. To provide. We will verify the usefulness of psychoeducation using guidebooks, such as how much these interventions improve or maintain stress states, and how much understanding of guidebooks is shown.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	12 weeks after the intervention, Hospital anxiety and depression scale(HADS)
Key secondary outcomes	No-hirou Scale, Literacy about stress management, Self-efficacy about stress management, Evaluation of "Stress management's Guidebook", The Japanese version of Recovery Experoence. Questionnaire: REQ-J, Fact-finding survey about the Promotion of Health and Employment Suppor

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	A intervention of Psychoeducation about stress management ,online group sessions, 60 min per session
Interventions/Control_2	Control group
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Fulfilling all of the following inclusion criteria: 1) >=20 yo <70 yo 2) Have inpatient treatment with cancer (gastric cancer, colon cancer, esophageal cancer, lung cancer, breast cancer, cervical cancer, liver cancer), stroke, angina, myocardial infarction, valvular heart disease, aortic aneurysm, arteriosclerosis obliterans or chronic organ failure (renal failure, Liver failure, heart failure) 3) Those who have returned to work or will return to work within two years of the start of the survey 4) >=10 score of No-hirou Scale at baseline 5) Have internet access to participate in online format program 6) Voluntary participation and comprehension of the purpose or risks of this study
Key exclusion criteria	Either: 1) Visit a psychiatrist for treatment of psychiatric disorders such as depression, schizophrenia, bipolar disorder, and dementia. 2) This study's researchers or their family members 3) Individuals whom researchers judge to inappropriate to participate in this study
Target sample size	34

Research contact person
Name of lead principal investigator	1st name kei Middle name Last name Hirai
Organization	Osaka University Graduate School
Division name	Education
Zip code	5650871
Address	1-2 Yamadaoka Suita-city, Osaka
TEL	0668798124
Email	khirai@hus.osaka-u.ac.jp

Public contact
Name of contact person	1st name kei Middle name Last name Hirai
Organization	Osaka University Graduate School
Division name	Education
Zip code	5650871
Address	1-2 Yamadaoka Suita-city, Osaka
TEL	0668798124
Homepage URL
Email	khirai@hus.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
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	Osaka University
Address	1-2 Yamadaoka Suita-city, Osaka
Tel	0668798139
Email	khirai@hus.osaka-u.ac.jp

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	2020 Year 09 Month 22 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	47
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	Completed
Date of protocol fixation	2020 Year 08 Month 11 Day
Date of IRB	2020 Year 08 Month 20 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 17 Day
Last modified on	2021 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047738