UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Support Aids for Fragile Elderly patients to ensure Proactive Coordinated care
Title of the study (Brief title)	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	Asao Ogawa
Organization	National Cancer Center Hospital East
Division name	Psycho-Oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa
TEL	04-7134-7013
Email	asogawa@east.ncc.go.jp

Public contact
Name of contact person	Asao Ogawa
Organization	National Cancer Center Hospital East
Division name	Psycho-Oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa
TEL	04-7134-7013
Homepage URL
Email	asogawa@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012486