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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003353
Receipt No. R000004070
Scientific Title A Randomized Wait-list Controlled Study of a 6-week Group Psychotherapy Program for Philippine Breast Cancer Patients
Date of disclosure of the study information 2010/03/18
Last modified on 2011/11/03

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Basic information
Public title A Randomized Wait-list Controlled Study of a 6-week Group Psychotherapy Program for Philippine Breast Cancer Patients
Acronym RCT of a 6-week group psychotherapy program for Philippine breast cancer patients
Scientific Title A Randomized Wait-list Controlled Study of a 6-week Group Psychotherapy Program for Philippine Breast Cancer Patients
Scientific Title:Acronym RCT of a 6-week group psychotherapy program for Philippine breast cancer patients
Region
Japan Asia(except Japan)

Condition
Condition Breast cancer
Classification by specialty
Medicine in general Hematology and clinical oncology Psychosomatic Internal Medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The main objectives of this research are the following 2 themes:

To clarify the effect on psychological outcomes, quality of life, coping skills, and subjective assessments of physical symptoms among Philippine breast cancer patients who undergo a 6-week group psychotherapy program.

To determine if there is a significant difference on the above outcomes among patients who undertake the 6-week group psychotherapy program compared to those who did not undergo the program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Mood symptoms (Profile of Mood States (POMS)) , Quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Scale (EORTC-QLQ-C30 and BR23)),
Anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), Coping skills level (Ways of Coping scale (WOC)) , Perception of social support (Multidimensional Scale of Social Support)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 6-week group psychoeducational program
Interventions/Control_2 No treatment; wait-listed, to undergo the same therapy program after intervention group has completed therapy.
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
65 years-old >=
Gender Female
Key inclusion criteria 1) Female breast cancer out-patients between Stages 1-3

2) From 4-24 months post-surgery

3) Not under active chemotherapy or radiotherapy treatment

4) Physically able (ECOG 2 or better) to come to the intervention site

5) Have given written informed consent
Key exclusion criteria 1)No diagnosed mental conditions that may hinder participation

2)Not currently taking any psychiatric medications.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dianne Ledesma
Organization School of Public Health,University of Tokyo
Division name Social Gerontology
Zip code
Address 3/F Medical Bldg 3, Graduate School of Medicine, University of Tokyo
TEL +813-5841-3514
Email

Public contact
Name of contact person
1st name
Middle name
Last name Dianne Ledesma
Organization University of Tokyo
Division name Social Gerontology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Social Gerontology,
School of Public Health,
University of Tokyo
Institute
Department

Funding Source
Organization Personal funding
Organization
Division
Category of Funding Organization Self funding
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 University hospital (Manila), University of Santo Tomas Hospital (Manila)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 18 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
2010 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 10 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 18 Day
Last modified on
2011 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004070

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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