UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005727
Receipt number 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 21:52:34

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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 Obstetrics 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 or person

Institute

Kansai Clinical Oncology Group

Institute

Department

Personal name



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

Value
https://center6.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