UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053041 |
|---|---|
| Receipt number | R000060513 |
| Scientific Title | Relationship between postoperative shoulder joint range of motion limitation and catastrophic thinking after breast cancer surgery using a psychological approach. |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2023/12/08 20:36:33 |
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Basic information
Public title
Do psychological aspects such as the perception of pain influence the problem of difficulty in raising the arm after breast cancer surgery?
Acronym
Does psychological aspect affect the problem of difficulty in raising the arm after breast cancer surgery?
Scientific Title
Relationship between postoperative shoulder joint range of motion limitation and catastrophic thinking after breast cancer surgery using a psychological approach.
Scientific Title:Acronym
Relationship between postoperative shoulder joint range of motion limitation and catastrophic thinking after breast cancer surgery.
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Relationship between postoperative shoulder joint range of motion limitation and catastrophic thinking after breast cancer surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of Motion
Key secondary outcomes
Pain Catastrophizing Scale
Hospital Anxiety and Depression Scale
Visual Analogue Scale
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1)Patients scheduled for surgery for breast cancer(first time)
(2)Independent in activities of daily living
(3)Female
Key exclusion criteria
(1) Patients with a history of breast cancer surgery
(2) Patients scheduled for surgery for bilateral breast cancer
(3) Patients scheduled for reconstructive surgery
(4) Patients with preoperative severe pain around the shoulder joint on the affected side
(5) Patients who cannot understand the content of the questionnaire
(6) Patients with a diagnosis of dementia
(7) Patients with neurological or psychiatric diseases
(8) Patients who could not perform either the preoperative, postoperative, or one-month postoperative evaluation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
1-1,Seiryo-machi,Sendai-city,Miyagi
TEL
022-717-7353
satoru.ebihara.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University Hospital
Division name
Tohoku University Hospital
Zip code
9808574
Address
1-1,Seiryo-machi,Sendai-city,Miyagi
TEL
022-717-7679
Homepage URL
ryota.sato.c3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1,Seiryo-machi,Sendai-city,Miyagi
Tel
022-717-8007
Med-kenkyo@grp.tohoku.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
| 2023 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze the influence of psychological factors such as pain catastrophic thoughts, depression, and anxiety on postoperative shoulder joint restriction after breast cancer surgery using logistic regression analysis.
Management information
Registered date
| 2023 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060513
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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