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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005727
Receipt No. R000006773
Scientific Title An evaluation of measuring instruments for psychologic distress in initial cancer treatment patients.-An assessment of "Impact and distress thermometer" by means of Hospital anxiety and depression scale(HADS)-
Date of disclosure of the study information 2011/06/15
Last modified on 2014/01/18

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Basic information
Public title An evaluation of measuring instruments for psychologic distress in initial cancer treatment patients.-An assessment of "Impact and distress thermometer" by means of Hospital anxiety and depression scale(HADS)-
Acronym HADS and D & I thermometer
Scientific Title An evaluation of measuring instruments for psychologic distress in initial cancer treatment patients.-An assessment of "Impact and distress thermometer" by means of Hospital anxiety and depression scale(HADS)-
Scientific Title:Acronym HADS and D & I thermometer
Region
Japan

Condition
Condition Patients who are diagnosed as malignant tumor and planned the initial treatments.
Classification by specialty
Surgery in general Chest surgery Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1) To determine the cut off value of "distress and impact thermometer" for more than adjustment disorder status utilized by non psychiarists.
Basic objectives2 Others
Basic objectives -Others 2) To evaluate psychologic distress rate and emotional changes from the diagnosis of malignancy to 6 months afterward by "distress and impact thermometer" and HADS.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The value of distress and impact thermometer and HADS.The rate of more than adjustment disorder in researched time.
Key secondary outcomes Back ground factors affect pschycologic distress.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Diagnosed malignant disease patients who are planned to treat for the first time.
2)Informed consent is required.
3)Wilking to fullfill the questionnaire for 3 times of 6 months.
4)Life expectancy is more than 6 months.
Key exclusion criteria 1) Already suffering for psychologic disease.
2) Judged inappropriate for this study by researcher.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Itani
Organization Kansai Clinical Oncology Group
Division name Osaka Red Cross Hospital Thorachic Surgery
Zip code
Address 5-53 Hudegasaki Tennnojiku Osaka
TEL 06-6774-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Itani
Organization Nara Prefectural Nara Hospital
Division name Ob & Gyn
Zip code
Address 1-30-1 Hiramatsu Nara
TEL 0742-46-6001
Homepage URL http://www.kcog.jp/
Email nuages@m3.kcn.ne.jp

Sponsor
Institute Kansai Clinical Oncology Group
Institute
Department

Funding Source
Organization Kansai Clinical Oncology Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor no
Name of secondary funder(s) no

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 関西臨床腫瘍研究会(KCOG)参加の以下の施設を予定。京大付属病院(京都府)、兵庫県立尼崎病院(兵庫県)、北野病院(大阪府)、兵庫医科大学付属病院(兵庫県)、関西労災病院(兵庫県)、大阪医科大学(大阪府)、京都府立医科大学(京都府)、静岡県立静岡がんセンター(静岡県)、聖隷浜松病院(静岡県)、名古屋市立大学(愛知県)、奈良医科大学奈良県)、三重大学(三重県)、大分大(大分県)、奈良県立奈良病院(奈良県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 15 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 Completed
Date of protocol fixation
2011 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospetive cohort study

Management information
Registered date
2011 Year 06 Month 06 Day
Last modified on
2014 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006773

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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