UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015783 |
|---|---|
| Receipt number | R000018365 |
| Scientific Title | Spiritual well-being in patients with advanced lung cancer and chronic obstructive pulmonary disease. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2017/06/29 18:43:21 |
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Basic information
Public title
Spiritual well-being in patients with advanced lung cancer and chronic obstructive pulmonary disease.
Acronym
Spiritual well-being in lung cancer and COPD.
Scientific Title
Spiritual well-being in patients with advanced lung cancer and chronic obstructive pulmonary disease.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hasegawa Takaaki |
Organization
Gifu municipal hospital
Division name
Department of respiratory and medical oncology
Zip code
Address
7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL
058-251-1101
takaaki_hase@bird.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hasegawa Takaaki |
Organization
Gifu municipal hospital
Division name
Department of respiratory and medical oncology
Zip code
Address
7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL
058-251-1101
Homepage URL
takaaki_hase@bird.ocn.ne.jp
Sponsor or person
Institute
Gifu municipal hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 28 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018365
