UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020595 |
|---|---|
| Receipt number | R000023775 |
| Scientific Title | Effect of education, and exercise program and on long term physical activity in post-operative breast cancer patients: randomised controll trial |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2024/08/09 17:12:05 |
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Basic information
Public title
Effect of education, and exercise program and on long term physical activity in post-operative breast cancer patients: randomised controll trial
Acronym
Effect of education, and exercise program in post-operative breast cancer patients
Scientific Title
Effect of education, and exercise program and on long term physical activity in post-operative breast cancer patients: randomised controll trial
Scientific Title:Acronym
Effect of education, and exercise program in post-operative breast cancer patients
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of physical education program on long-term physical activity, quality of life, body mass index, bone densty, fatigue, cancer-related symtoms, lymph edema, and physcologial aspects in post-operative breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
physical activity at 1 year after registration
Key secondary outcomes
QOL, cancer- and treatment-related symptoms, fatigue, body mass index, bone density, lymph edema, anxiety and depression
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
education program
Interventions/Control_2
exercise program
Interventions/Control_3
control
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. Post-initial tretment (during 1 year after initial tretment) breast cancer patients with Stage 0-3.
2. Written informed consent.
Key exclusion criteria
Intolerance case with exercise program
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Naruto |
| Middle name | |
| Last name | Taira |
Organization
Kawasaki medical school
Division name
Department of Breast and Thyroid surgery
Zip code
701-0192
Address
577 Matsushima, Kurashiki-city, Okayama
TEL
0864621111
ntaira@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Naruto |
| Middle name | |
| Last name | Taira |
Organization
Kawasaki medical school
Division name
Breast and Thyroid Surgery
Zip code
701-0192
Address
577 Matsushima, Kurashiki-city, Okayama
TEL
0864621111
Homepage URL
ntaira@med.kawasaki-m.ac.jp
Sponsor or person
Institute
SBP
Institute
Department
Personal name
Funding Source
Organization
Kaken-B
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
Shikata-cho 2-5-1, Okayama city
Tel
086-235-6938
mae6605@adm.okayama-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
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37852895/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37852895/
Number of participants that the trial has enrolled
356
Results
There were no significant differences in proportion of RPA at 1 year between the exercise and control groups.
Results date posted
| 2024 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Overall, the characteristics of the patients at baseline were well balanced among the 3 groups, except for HER2 status (P = .026) and anti-HER2 therapy (P = .046)
Participant flow
From March 16 2016 to March 15, 2020, 356 patients with breast cancer were enrolled at 6 sites (Fukuyama City Hospital, Japanese Red Cross Okayama Hospital, Kagawa Prefectural Central Hospital, Kochi Health Science Center, National Hospital Organization Shikoku Cancer Center, and Okayama University Hospital) and randomly assigned to the control (n = 120), education (n = 121), or exercise (n = 115) group.
Adverse events
none
Outcome measures
physical activity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023775
