UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040651 |
|---|---|
| Receipt number | R000046401 |
| Scientific Title | Effects of Short-term Existential Group Therapy for Breast Cancer Patients |
| Date of disclosure of the study information | 2020/06/04 |
| Last modified on | 2020/06/04 16:18:02 |
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Basic information
Public title
Effects of Short-term Existential Group Therapy for Breast Cancer Patients
Acronym
Effects of Short-term Existential Group Therapy for Breast Cancer Patients
Scientific Title
Effects of Short-term Existential Group Therapy for Breast Cancer Patients
Scientific Title:Acronym
Effects of Short-term Existential Group Therapy for Breast Cancer Patients
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effects of Short-term Existential Group Therapy for Breast Cancer Patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Skalen zur Erfassung von Lebensqualitat bei Tumorkranken(SELT-M)
Key secondary outcomes
1,Profile of Mood States - brief form (POMS)
2,Mental Adjustment to Cancer (MAC)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A ninety-minute therapeutic group session was held once a week for five weeks. Each session consisted of between five to seven subjects with a psychiatrist and clinical psychologist as facilitators, and with a specific subject of discussion, as described below (1st), 2nd), 3rd), 4th), 5th)).1st) Talk freely about yourself,2nd) Share your anxieties. 3rd) Re-Construct human relationships. 4th) Cope with the stresses. 5th) Know who you are.
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1)having been diagnosed with breast cancer within twelve months prior to enrolling in the study
2)30-65 years old
3)note of whether they had received adjuvant chemotherapy.
4)having had breast surgery (conservative or mastectomy), diagnosis of breast cancer at disease onset,
5)subjects were screened with the Hospital Anxiety and Depression Scale (HADS)
Key exclusion criteria
1)inappropriate to participate judged by researchers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Kawase |
Organization
Kyoto Notre Dame University
Division name
Department of Psychology
Zip code
6060847
Address
1 Minami-Nonogamicho, Shimogamo, Sakyoku, Kyoto
TEL
075-781-1173
groupsawai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Kawase |
Organization
Kyoto Notre Dame University
Division name
Department of Psychology
Zip code
6060847
Address
1 Minami-Nonogamicho, Shimogamo, Sakyoku, Kyoto
TEL
075-781-1173
Homepage URL
groupsawai@yahoo.co.jp
Sponsor or person
Institute
Kyoto Notre Dame University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Notre Dame University
Address
1 Minami-Nonogamicho, Shimogamo, Sakyoku, Kyoto
Tel
075-781-1173
kenkyu@ml.notredame.ac.jp
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
| 2020 | Year | 06 | Month | 04 | 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
40
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
Main results already published
Date of protocol fixation
| 2007 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2007 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2008 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046401
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
