UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056376 |
|---|---|
| Receipt number | R000064403 |
| Scientific Title | Investigating the Effectiveness of a Combined Intervention Based on a Nurse-Led Multidimensional Assessment for the Management of Postoperative Adverse Effects of Breast Cancer. |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2024/12/06 10:19:45 |
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Basic information
Public title
A nurse-led study on comprehensive management of postoperative side effects of breast cancer
Acronym
A nurse-led study on comprehensive management of postoperative side effects of breast cancer
Scientific Title
Investigating the Effectiveness of a Combined Intervention Based on a Nurse-Led Multidimensional Assessment for the Management of Postoperative Adverse Effects of Breast Cancer.
Scientific Title:Acronym
Investigating the Effectiveness of a Combined Intervention Based on a Nurse-Led Multidimensional Assessment for the Management of Postoperative Adverse Effects of Breast Cancer.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of nurse-led, multidisciplinary assessment-based management of postoperative side effects in postoperative breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BPI pain intensity
Key secondary outcomes
Disability(Quick DASH,BPI interference),Central sensitization-related symptoms,Pain catastorphizing(PCS 6),anxiety(GAD 2),depression(PHQ 2),Health related quality of life(EQ 5D 5L),physical activity(GPAQ),public health care costs and other costs.Muscle strength,upper limb volume,and shoulder joint range of motion testing
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients diagnosed with breast cancer and undergoing/receiving surgery at the Breast Surgery Department of Izumi City General Medical Center
(1) Patients aged 20-80 years old who have been diagnosed with breast cancer
(2) Patients with Clinical stage 0-III
Key exclusion criteria
(1) Those with recurrent or metastatic cancer
2) Male patients
(3) Patients scheduled for breast reconstruction or post-reconstructive surgery
(4) Patients who received outpatient rehabilitation for upper limb symptoms after breast cancer surgery
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Shirai |
Organization
Izumi City General Medical Center
Division name
Nursing Department
Zip code
594-0073
Address
4-5-1, Wake-Cho, Izumi-shi, Osaka, Japan
TEL
0725-41-1331
masami.shirai@tokushukai.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Shirai |
Organization
Izumi City General Medical Center
Division name
Nursing Department
Zip code
594-0073
Address
4-5-1, Wake-Cho, Izumi-shi, Osaka, Japan
TEL
0725-41-1331
Homepage URL
masami.shirai@tokushukai.jp
Sponsor or person
Institute
Izumi City General Medical Center
Institute
Department
Personal name
Masami Shirai
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Breast Care Senshu Clinic
Name of secondary funder(s)
None.
IRB Contact (For public release)
Organization
Tokushukai Group Joint Ethics Review Committee
Address
1-3-1, Kudan-minami, Chiyoda-ku, Tokyo
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
| 2024 | Year | 12 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to examine the effectiveness of nurse-led, multidisciplinary assessment-based postoperative side-effect management in postoperative breast cancer patients.
Management information
Registered date
| 2024 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064403
