UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031716 |
|---|---|
| Receipt number | R000036224 |
| Scientific Title | Study on the effect of education for preventing and improving health risk after surgical menopause of gynecological cancer |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/12/26 11:51:50 |
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Basic information
Public title
Study on the effect of education for preventing and improving health risk after surgical menopause of gynecological cancer
Acronym
Randomized controlled trials of health education for gynecological cancer surgical postmenopausal patients
Scientific Title
Study on the effect of education for preventing and improving health risk after surgical menopause of gynecological cancer
Scientific Title:Acronym
Randomized controlled trials of health education for gynecological cancer surgical postmenopausal patients
Region
| Japan |
Condition
Condition
Gynecological cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Gynecologic cancer surgical intervention Educational intervention aiming at prevention and improvement of health risk after menopause will be conducted and its effectiveness will be verified by randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Simplified menopause index (SMI), Lipid metabolism abnormality: LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), triglyceride (TG), Osteoporosis: bone metabolism marker
2. Evaluation period: baseline, 6 months, after 12 months
Key secondary outcomes
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
Intervention period: 12 months
Regular consultation and personal education
Contents of personal education
Duration: 60 minutes per session
Number of interventions: 1 before health hospitalization, 2 before discharge, 2 times after discharge, 5 times in total
Interventions/Control_2
Intervention period: 12 months
Normal examination only
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
| Not applicable |
Gender
Female
Key inclusion criteria
Disease name: gynecological cancer (cervical cancer, uterine body cancer, ovarian cancer)
Stage: cervical cancer: IA or more, uterine body cancer: stage I or more, ovarian cancer: stage I or more
Key exclusion criteria
Gynecological cancer not notified, outpatient visit is impossible, already menopausal before treatment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mizue |
| Middle name | |
| Last name | Inoue |
Organization
Fukushima Medical University
Division name
Faculty of Nursing
Zip code
9601295
Address
Fukushima Prefecture Fukushima-city Hikarigaoka 1
TEL
024-547-1841
i-mizue@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Mizue |
| Middle name | |
| Last name | Inoue |
Organization
Fukushima Medical University
Division name
Faculty of Nursing
Zip code
9601295
Address
1 Hikarigaoka,Hukushima-shi,Hukushima
TEL
024-547-1841
Homepage URL
i-mizue@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University School of Medicine Ethics Committee
Address
2-1 Seiryo-cho, Aoba-ku, Sendai-shi
Tel
022-717-8007
med-kenkyo@bureau.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
| 2018 | Year | 04 | Month | 01 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 03 | Month | 14 | Day |
Last modified on
| 2019 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036224
