UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022426 |
|---|---|
| Receipt number | R000025844 |
| Scientific Title | Retrospective prognosis study of death at home or hospice versus at hospital end-of-life for advanced Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2016/05/24 |
| Last modified on | 2019/07/05 11:58:26 |
* 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
Retrospective prognosis study of death at home or hospice versus at hospital end-of-life for advanced Non-Small Cell Lung Cancer
Acronym
Prognosis survey end-of-life for advanced non-small cell lung cancer
Scientific Title
Retrospective prognosis study of death at home or hospice versus at hospital end-of-life for advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym
Prognosis survey end-of-life for advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation prognosis for the end-of-life of patients with non-small cell lung cancer, as compared to the hospital facility that can be subjected to aggressive treatment, and patients who have reached the end-of-life at home relaxation or hospice.
Basic objectives2
Others
Basic objectives -Others
Evaluation for patients information as bellow; age, sex, smoking, PS, Date of diagnosis, EGFR mutation, ALK rearrangement,
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Survival time from last chemotherapy
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
Treated with chemotherapy for advanced non-small cell lung cancer
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoichiro |
| Middle name | |
| Last name | Hamamoto |
Organization
National Hospital Organization Nishisaitama-Chuo National Hospital
Division name
Department of Pulmonary Medicine
Zip code
359-1151
Address
2-1671 Wakasa, Tokorozawa city, Saitama, Japan
TEL
04-2948-1111
hamamoto32@gmail.com
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Hamamoto |
Organization
National Hospital Organization Nishisaitama-Chuo National Hospital
Division name
Department of Pulmonary Medicine
Zip code
359-1151
Address
2-1671 Wakasa, Tokorozawa city, Saitama, Japan
TEL
04-2948-1111
Homepage URL
hamamoto32@gmail.com
Sponsor or person
Institute
National Hospital Organization Nishisaitama-Chuo National Hospital
Department of Pulmonary Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
the Institutional Review Board of National Hospital Organization Nishisaitama-Chuo National Hospital
Address
2-1671 Wakasa, Tokorozawa city, Saitama, Japan
Tel
04-2948-1111
odajima.masafumi.mg@mail.hosp.go.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
独立行政法人国立病院機構 西埼玉中央病院(埼玉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 24 | 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
313
Results
Among the 313 patients recruited, 214 were analyzed in this study: 90, 49, and 75 received hospital-based, home-based, and hospice-based palliative care, respectively. The patients who died at a hospice exhibited significantly longer survival than those that died at hospital (estimated median survival time, 420 days [95% confidence interval, 325-612 days] vs. 252 days [95% CI, 201-316 days]; P<0.0001). The characteristics of patients did not differ significantly according to place of death.
Results date posted
| 2019 | Year | 07 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 09 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 17 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 21 | Day |
Other
Other related information
Case control study
<Patients eligibility criteria>
From April 2010 to December 2015, patients were recruited as eligible criteria for advanced non-small cell lung cancer<Primary endpoint>
Overall survival from first chemotherapy
Management information
Registered date
| 2016 | Year | 05 | Month | 24 | Day |
Last modified on
| 2019 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025844
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/07/05 | 2016_08_19 Palliative care Protocol.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
