UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Spiritual well-being in patients with advanced lung cancer and chronic obstructive pulmonary disease.
Title of the study (Brief title)	Spiritual well-being in lung cancer and COPD.
Region	Japan

Condition
Condition	advanced or recurrent lung cancer and chronic obstructive pulmonary disease
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the levels of spiritual well-being in populations with advanced lung cancer or chronic obstructive pulmonary disease.
Basic objectives2	Others
Basic objectives -Others	To evaluate the levels of spiritual well-being
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the relation between the levels of spiritual well-being and the type of illness(lung cancer or COPD).
Key secondary outcomes	the relation between the levels of spiritual well-being and age, sex, MRC score or QOL.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with a lung cancer or COPD diagnosis an age of 20 years or older well enough to complete the questionnaire, thought to have a poor prognosis
Key exclusion criteria	severe mental or cogniitive disorder an inability to understand the japanese language
Target sample size	100

Research contact person
Name of lead principal investigator	Hasegawa Takaaki
Organization	Gifu municipal hospital
Division name	Department of respiratory and medical oncology
Address	7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL	058-251-1101
Email	takaaki_hase@bird.ocn.ne.jp

Public contact
Name of contact person	Hasegawa Takaaki
Organization	Gifu municipal hospital
Division name	Department of respiratory and medical oncology
Address	7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL	058-251-1101
Homepage URL
Email	takaaki_hase@bird.ocn.ne.jp

Sponsor
Institute	Gifu municipal hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 12 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 11 Month 28 Day
Anticipated trial start date	2014 Year 12 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	We evaluate the relation between the levels of spiritual well-being and the type of illness(lung cancer or COPD). We use multiple logistic regression to investigate the relation between the spritual well-being and age/sex/dyspnea/QOL.

Management information
Registered date	2014 Year 11 Month 28 Day
Last modified on	2017 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018365