UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003353 |
|---|---|
| Receipt number | 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 18:43:45 |
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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
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
Sponsor or person
Institute
Department of Social Gerontology,
School of Public Health,
University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004070
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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