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
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
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
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
