UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001274 |
|---|---|
| Receipt number | 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 15:11:05 |
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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 | Obstetrics 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)
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/
info@gankanwa.jp
Sponsor or person
Institute
Outreach Palliative care Trial of Integrated regional Model
OPTIM study project
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001551
