UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053270 |
|---|---|
| Receipt number | R000059704 |
| Scientific Title | Changes in dyspnea and supportive care in patients with advanced lung cancer: a retrospective observational study |
| Date of disclosure of the study information | 2024/01/08 |
| Last modified on | 2024/01/08 09:32:36 |
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Basic information
Public title
Changes in dyspnea and supportive care in patients with advanced lung cancer: a retrospective observational study
Acronym
Changes in dyspnea and supportive care in patients with advanced lung cancer: a retrospective observational study
Scientific Title
Changes in dyspnea and supportive care in patients with advanced lung cancer: a retrospective observational study
Scientific Title:Acronym
Changes in dyspnea and supportive care in patients with advanced lung cancer: a retrospective observational study
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the changes in the degree of dyspnea and the reality of supportive care in patients with advanced lung cancer.
Basic objectives2
Others
Basic objectives -Others
To investigate the clinical status
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dyspnea
Key secondary outcomes
- Respiratory-related symptoms
- Supportive care
- General condition
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Received treatment at pulmonary medicine from 2013 to December 2022
- Advanced lung cancer
- Had dyspnea at outpatient respiratory medicine
- Died at the Hospital where research was conducted between 2013 and December 2022
Key exclusion criteria
- Transferred to a different hospital
- Not received treatment at respiratory medicine
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Yagasaki |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-2157
yagasaki@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yagasaki |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-2157
Homepage URL
yagasaki@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 01 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a one-year retrospective observational study using the electronic medical record to observed respiratory-related symptoms, supportive care and general condition.
The subjects are those with a history of attending institutions that met the selection criteria.
Data will be collected from records of the date outpatients visit and the duration of their hospitalization from one year prior to death as a baseline.
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059704
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
