UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038299 |
|---|---|
| Receipt number | R000043590 |
| Scientific Title | Effects of stress management on psychological distress in breast cancer patients |
| Date of disclosure of the study information | 2019/11/15 |
| Last modified on | 2023/12/09 21:57:20 |
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Basic information
Public title
Effects of stress management on psychological distress in breast cancer patients
Acronym
stress management in breast cancer patients
Scientific Title
Effects of stress management on psychological distress in breast cancer patients
Scientific Title:Acronym
stress management in breast cancer patients
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of study is to clarify the effects of stress management on psychological distress and uncertainty for disease in breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hospital Anxiety and Depression Scale(HADS)
Universal Uncertainty in Illness Scale(UUIS):[Unpredictability of Daily Life][Complexity of lnterpretation of lnformation][Lack of Cues Finding Meaning in Illness][Ambiguity of Characteristics of Illness][Unpredictability Recovery from Illness][lnstability of Self-confidence in Carrying on a Struggle against Illness]
Key secondary outcomes
writtin freely comments
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
psychoeducational intervention and relaxation
Interventions/Control_2
No intervention
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
Primary breast cancer patients (up to Stage III)
Key exclusion criteria
Mental disorder
Severe physical disease
They are undergoing psychotherapy
Physician' judgement
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Iwamitsu |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
2520373
Address
1-15-1 Kitasato Minami-ku Sagamihara, Kanagawa, Japan
TEL
042-778-7961
iyumi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Iwamitsu |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
2520373
Address
1-15-1 Kitasato Minami-ku Sagamihara, Kanagawa, Japan
TEL
042-778-7961
Homepage URL
mpsy01@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1 Kitasato Minami-ku Sagamihara, Kanagawa, Japan
Tel
042-778-7961
rinri@med.kitasato-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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 15 | 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
86
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
| 2019 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043590
| 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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| Registered date | File name |
