UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041820 |
|---|---|
| Receipt number | R000047738 |
| Scientific Title | Effect verification of interventing by "The Guidebook for Stress management about the Promotion of Health and Employment Support" |
| Date of disclosure of the study information | 2020/09/22 |
| Last modified on | 2021/03/22 14:21:53 |
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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
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
khirai@hus.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047738
