UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035837 |
|---|---|
| Receipt number | R000040823 |
| Scientific Title | Effects of a short term psychotherapy in postoperative breast cancer patients: an exploratory study |
| Date of disclosure of the study information | 2019/02/11 |
| Last modified on | 2025/08/31 15:25:41 |
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Basic information
Public title
Effects of a short term psychotherapy in postoperative breast cancer patients: an exploratory study
Acronym
EBICe Study
Scientific Title
Effects of a short term psychotherapy in postoperative breast cancer patients: an exploratory study
Scientific Title:Acronym
EBICe Study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Psychosomatic Internal Medicine | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To obtain preliminary data to design a randomized controlled trial examining the effects of a short term psychotherapy "autonomy training" in postoperative breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuroendocrinoimmunological biomarkers, oncological markers, and behavioral indices
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Psychotherapy "Autonomy Training":
- A personal interview of one to three hours per time
- One- to three-time interviews for one participant
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1) Age from 20 to 69 years
2) Reccurence free two years of the first operation
3) Competence of smooth communication in Japanese and answering self-administered questionnaires
4) Give signed consent
Key exclusion criteria
1) History of other neoplasms
2) History of corticosteroid therapy within one month
3) Diseases possibly affect the immune system
4) Other conditions doctor judges innapropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Nagano |
Organization
Center for Health Sciences and Counseling, Kyushu University
Division name
Division of Health Sciences
Zip code
819-0395
Address
744 Motooka, Nishiku, Fukuoka
TEL
092-802-5118
nagano@chc.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Nagano |
Organization
Center for Health Sciences and Counseling, Kyushu University
Division name
Division of Health Sciences
Zip code
819-0395
Address
744 Motooka, Nishiku, Fukuoka
TEL
092-802-5118
Homepage URL
nagano@chc.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu 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
Kyushu University Hospital Clinical Studies Ethics Commitee
Address
3-1-1 Maidashi, Higashiku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
| 2019 | Year | 02 | Month | 11 | Day |
Related information
URL releasing protocol
https://archive.iii.kyushu-u.ac.jp/public/eE5gwCEIP5071Johq5mk5aXXi5xJsnOLj-E6CI9b5Ejz
Publication of results
Unpublished
Result
URL related to results and publications
https://archive.iii.kyushu-u.ac.jp/public/eE5gwCEIP5071Johq5mk5aXXi5xJsnOLj-E6CI9b5Ejz
Number of participants that the trial has enrolled
22
Results
Follow-up and data collection have been completed. However, data analysis has not yet begun due to personal reasons (unrelated to the study) among the researchers.
Results date posted
| 2025 | Year | 08 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female breast cancer patients aged 20 to 70 years who have not experienced recurrence for more than two years after receiving treatment, including surgery.
Participant flow
Participants completed a baseline survey, including self-administered questionnaires, blood tests, and Holter ECG monitoring, followed by a short-term psychotherapy session called "Autonomy Training," administered by a certified psychologist. They then completed follow-up surveys with the same content as the baseline survey three and six months after the session ended.
Adverse events
No notable events were observed.
Outcome measures
We will exploratory-examine and consider the changes in subjective and objective data before and after the intervention from the following perspectives:
(1) Which indicators change?
(2) Is the quality, direction, and relationship between indicators of change appropriate?
(3) What is the magnitude of the change (effect size)?
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 11 | Day |
Last modified on
| 2025 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040823
