UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010679 |
|---|---|
| Receipt number | R000012486 |
| Scientific Title | Support Aids for Fragile Elderly patients to ensure Proactive Coordinated care |
| Date of disclosure of the study information | 2013/05/09 |
| Last modified on | 2017/11/12 13:37:15 |
* 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
Support Aids for Fragile Elderly patients to ensure Proactive Coordinated care
Acronym
SAFE-PAC
Scientific Title
Support Aids for Fragile Elderly patients to ensure Proactive Coordinated care
Scientific Title:Acronym
SAFE-PAC
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Medicine in general | Pneumology | Geriatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of the case management for elderly cancer patients based on the comprehensive geriatric assessmentand symptom monitoring system with ICT clouds.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of patients completed at least 50% of their scheduled visits and QOL assessments in 6 months
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
case manegement by trained nurses
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients within 8 weeks of diagnosis of advanced NSCLC (stage IV) confirmed by histology or cytology were eligible for this study. Other eligibility requirements included age more than 65 years,
Key exclusion criteria
Patients with obvious impairment of consciousness
Patients with sever pain, dyspnea, fatigue, and nausea and vomiting is severe
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asao Ogawa |
Organization
National Cancer Center Hospital East
Division name
Psycho-Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa
TEL
04-7134-7013
asogawa@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asao Ogawa |
Organization
National Cancer Center Hospital East
Division name
Psycho-Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa
TEL
04-7134-7013
Homepage URL
asogawa@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 09 | Day |
Last modified on
| 2017 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012486
