UMIN-CTR Clinical Trial

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
Email	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
Email	kobakuni@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052463