UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001354
Receipt number R000001647
Scientific Title Isis - Internetdelivered support for individuals with secondary concerns after breast cancer - an individualised CBT-treatment compared to group treatment
Date of disclosure of the study information 2008/12/10
Last modified on 2008/09/03 15:24:10

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Basic information

Public title

Isis - Internetdelivered support for individuals with secondary concerns after breast cancer - an individualised CBT-treatment compared to group treatment

Acronym

Internetdelivered CBT compared to group treatment for psychological problems after breastcancer

Scientific Title

Isis - Internetdelivered support for individuals with secondary concerns after breast cancer - an individualised CBT-treatment compared to group treatment

Scientific Title:Acronym

Internetdelivered CBT compared to group treatment for psychological problems after breastcancer

Region

Europe


Condition

Condition

Anxiety, depression, social phobia and related psychological issues in breastcancer survivors

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate if a population suffering from various psychological problems after breast cancer could benefit from individualized Internet-delivered CBT with therapist guidance and/or online group treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HADS, MADRS-S, BITS, QOLI, ISI, Benefit finding, CGI.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Individualized internet-delivered CBT with therapist guidance

Interventions/Control_2

Support-group treatment

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

Female

Key inclusion criteria

Had gone through breast cancer treatment
Anxiety and/or depression as measured by Hospital anxiety and depression scale (HAD)

Key exclusion criteria

In other CBT-treatment
Active cancer treatment
Suicidal
Severely depressed
Severe alcohol dependence

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Gerhard Andersson

Organization

Linkoping University

Division name

Department of Behavioural Sciences and Learning.

Zip code


Address

SE-581 83 LINKOPING, Sweden

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Linkoping University

Division name

Department of Behavioural Sciences and Learning.

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Linkoping University

Institute

Department

Personal name



Funding Source

Organization

Cancerfonden

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

2008 Year 12 Month 10 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

Preinitiation

Date of protocol fixation

2007 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2007 Year 08 Month 01 Day

Last follow-up date

2012 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 09 Month 03 Day

Last modified on

2008 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001647


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name