UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034527 |
|---|---|
| Receipt number | R000039356 |
| Scientific Title | The effect of a comprehensive long-term rehabilitation care program to promote the life reconstruction of the breast cancer patients |
| Date of disclosure of the study information | 2018/10/16 |
| Last modified on | 2023/11/14 17:02:27 |
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Basic information
Public title
The effect of a comprehensive long-term rehabilitation care program to promote the life reconstruction of the breast cancer patients
Acronym
The effect of breast cancer rehabilitation care program
Scientific Title
The effect of a comprehensive long-term rehabilitation care program to promote the life reconstruction of the breast cancer patients
Scientific Title:Acronym
The effect of breast cancer rehabilitation care program
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comprehensive rehabilitation care aimed at promoting living restructuring of breast cancer patients was carried out up to 3 years after operation and the effect of care was evaluated by randomized controlled trial with breast cancer specific QOL scale (FACT - B) as primary outcome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FACT-B (Functional Assessment of Cancer Therapy-Breast)
Outcomes are measured before surgery,and 3months,12months and 3 years after surgery
Key secondary outcomes
Simplified Menopausal Index(SMI)
arm girth,shoulder ROM,and grip strength
Self-reported questionnaires,the Subjective Perception of Post-Operative Functional Impairment of the Arm(SPOFIA)
the Disabilities of the Arm,Shoulder and Hand(DASH)
Self-Care Agency Questionnaire(SCAQ)
body weight,LDL-C,HDL-C,Triglyceride
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Comprehensive rehabilitation care program participation group
Interventions/Control_2
Postoperative upper limb dysfunction training program participation group
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
| 20 | years-old | > |
Gender
Female
Key inclusion criteria
Women who undergo surgical therapy with primary breast cancer,Invitation Survey Registration at least 20 years old,No cognitive dysfunction,can be sent to a hospital,obtain the consent of participating in the research document.
Key exclusion criteria
Can't communicate with cognitive dysfunction,can't speak Japanese,can't come to hospital.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
School Nursing,
Zip code
960-1295
Address
1, Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan,
TEL
+81-24-547-1874
stfumiko@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
School of Nursing
Zip code
960-1296
Address
1, Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan,
TEL
+81245471874
Homepage URL
stfumiko@fmu.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Fumiko Sato
Funding Source
Organization
the 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
Ethics Committee, Graduate School of Medicine, Tohoku University
Address
2-1 Seiryo-machi,Aoba-ku,Sendai, Miyagi 980-8575 Japan
Tel
+81-22-728-4105
https://www.rinri.med.tohoku.ac.jp/portal/
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
東北大学病院(宮城県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 06 | 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
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039356
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
