UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007399 |
|---|---|
| Receipt number | R000008466 |
| Scientific Title | Special Project for Awareness and Relief of Cancer Symptom |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2014/08/28 16:37:25 |
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Basic information
Public title
Special Project for Awareness and Relief of Cancer Symptom
Acronym
SPARCS
Scientific Title
Special Project for Awareness and Relief of Cancer Symptom
Scientific Title:Acronym
SPARCS
Region
| Japan |
Condition
Condition
Cancer patients with pain
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development and validation of indicators for facility performance on relief of cancer pain
Basic objectives2
Others
Basic objectives -Others
Validation of measurement and evaluation of training
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain Relief Rate, Level of Pain among cancer patients
Key secondary outcomes
Quality of Life, QOL, Symptom Relief of cancer patients
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with malignant disease or intracranial tumor hospitalized during the study period
Key exclusion criteria
Refusal of the medical information for research use
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiro Matoba |
Organization
Aomori Prefetural Central Hospital
Division name
Department of Palliative Medicine
Zip code
Address
2-1-1 Higashitsukurimichi, Aomori
TEL
017-726-8111
sparcs_ml@aomori-kenbyo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Higashi |
Organization
National Cancer Center
Division name
Division of Health Services Research
Zip code
Address
5-1-1 Tukiji Chuoh-ku, Tokyo
TEL
03-3542-2511
Homepage URL
thigashi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aomori Prefectural Central Hospital
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
| 2012 | Year | 03 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pain relief indicators and quality of life questionnaire are continuously implemented. During the measurement period, a series of educational sessions for health professionals of the participating hospital are held as part of the continuous medical education. We examine the change in the measurements, through which we test the validity of the pain relief indicators.
Management information
Registered date
| 2012 | Year | 02 | Month | 28 | Day |
Last modified on
| 2014 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008466
