UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001274
Receipt No. R000001551
Scientific Title Outreach palliative care Trial of integrated regional model
Date of disclosure of the study information 2008/07/31
Last modified on 2008/07/29

* 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 Outreach palliative care Trial of integrated regional model
Acronym Outreach palliative care Trial of integrated regional model
(OPTIM Study)
Scientific Title Outreach palliative care Trial of integrated regional model
Scientific Title:Acronym Outreach palliative care Trial of integrated regional model
(OPTIM Study)
Region
Japan

Condition
Condition Cancer
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Endocrinology and Metabolism Hematology and clinical oncology
Nephrology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Dermatology
Oto-rhino-laryngology Orthopedics Urology
Radiology Anesthesiology Oral surgery
Neurosurgery Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary aim of this study is to evaluate whether a systematic, multi-intervention regional palliative care program can improve the quality of life of cancer patients in the community. The ultimate propose of this study is to develop a success model of regional palliative care suitable for Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)patient-reported quality of palliative care
2)bereaved family-reported quality of palliative care
3)number of patients who received specialized palliative care services
4)place of death distribution
The quality of palliative care is measured by the Care Evaluation Scale, a validated tool to quantify user-perceived quality of care
Key secondary outcomes 1)knowledge, competency, and difficulties of regional physicians and nurses
2)quality indicators of regional palliative care, including opioid consumption and the number of nursing agencies providing around-the clock services.

Base
Study type Interventional

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The following multidimensional intervention:
1) disseminating standardized clinical tools
2) providing appropriate information about palliative care to the general public, patients and their family
3) establishing whole-region organization to coordinate community palliative care
4) establishing specialized palliative care services available in the community
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria This trial involves 4 intervention regions with different palliative care system development across Japan: Chiba (Kashiwa city), Shizuoka (Hamamatsu city), Nagasaki (Nagasaki city), and Yamagata (Tsuruoka, Mikawa-cho; Figure 1). Chiba, Shizuoka, and Nagasaki have a growing organized system to provide palliative care led by a national cancer center, a general hospital, and a regional general practitioner association, respectively. Yamagata has an unorganized system of palliative care.
The study subjects are all residents of the participating regions, including the general public, patients, their families, and health care providers.

Key exclusion criteria The residents who disagree with the participation of this study are excluded.
Target sample size 2000000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Eguchi
Organization Teikyo University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605
TEL 03-3694-1211(ext.1968)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Eguchi
Organization Teikyo University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605
TEL 03-3694-1211(ext.1968)
Homepage URL http://www.gankanwa.jp/
Email info@gankanwa.jp

Sponsor
Institute Outreach Palliative care Trial of Integrated regional Model
OPTIM study project
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications http://www.gankanwa.jp/
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 No longer recruiting
Date of protocol fixation
2008 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 07 Month 29 Day
Last modified on
2008 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001551

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.