UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045962 |
|---|---|
| Receipt number | R000052463 |
| Scientific Title | Comparison of spiritual well-being among generations and among cultures |
| Date of disclosure of the study information | 2021/11/03 |
| Last modified on | 2022/11/02 17:51:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of spiritual well-being among generations and among cultures
Acronym
spiritual well-being of high school students
Scientific Title
Comparison of spiritual well-being among generations and among cultures
Scientific Title:Acronym
KSH-SSH01/NEJ055
Region
| Japan |
Condition
Condition
Spirituality
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate structures of spiritual well-being of high school students
To compare spiritual well-being of high school students to that of patients with cancer
Basic objectives2
Others
Basic objectives -Others
convergent validity
discriminant validity
internal consistency
Known-group comparison
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
principal component analysis
inter-scale correlation
Key secondary outcomes
Base
Study type
Observational
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)High school students who answered EORTC QLQ-SWB32 on 21 March 2021
2)Lung cancer patients who answered EORTC QLQ-SWB32
Key exclusion criteria
People who desire opt-out
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Kunihiko |
| Middle name | |
| Last name | Kobayashi |
Organization
Saitama Medical University International Medical Center
Division name
Department of Respiratory Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka City
TEL
+81429844111
kobakuni@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiko |
| Middle name | |
| Last name | Kobayashi |
Organization
Saitama Medical University International Medical Center
Division name
Dept. of Respiratory Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka City
TEL
+81429844111
Homepage URL
kobakuni@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
North East Japan Study Group
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center CCRI
Address
1397-1 Yamane, Hidaka City
Tel
+81429844111
imc_irb@saitama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
KSH-SSH01
Org. issuing International ID_1
Kumagaya Senior High School
Study ID_2
NEJ055
Org. issuing International ID_2
North East Japan Study Group
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
285
Results
Among 283 male students, there were 142 non-believers (50%), 98 light believers (35%), and 43 deep believers (15%). Relationship with self (RS) correlated with global SWB in non-believers and light believers (r<- 0.4). Among groups, light believers had significantly better global SWB than non-believers and deep believers (p=0.0312).
Results date posted
| 2022 | Year | 11 | Month | 02 | Day |
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
| 2021 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of spirituality between high school students and lung cancer patients retrospectively, using the EORTC SWB module
Management information
Registered date
| 2021 | Year | 11 | Month | 02 | Day |
Last modified on
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052463
