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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name