UMIN-CTR Clinical Trial

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
Email	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
Email	i-mizue@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036224