UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of evaluating health behavior support system with leaflet distribution for women with gynecological cancer.
Acronym	Feasibility study of evaluating health behavior support system with leaflet distribution.
Scientific Title	Feasibility study of evaluating health behavior support system with leaflet distribution for women with gynecological cancer.
Scientific Title:Acronym	Feasibility study of evaluating health behavior support system with leaflet distribution.
Region	Japan

Condition
Condition	Gynecological cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the feasibility of health behavior support system with leaflet distribution for women with gynecological cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Leaflet assessment: reading frequency, accessibility, visibility, readability, usefulness, satisfaction level, level of intention to engage in health behavior
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Leaflet distribution on health behaviors for women with gynecological cancer.
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	65 years-old >
Gender	Female
Key inclusion criteria	1) Women with ovarian, cervical or endometrial cancer 2) 3 months or more after the end of initial primary treatment(surgery, chemotherapy, radiotherapy) 3) being employed
Key exclusion criteria	1) cancer recurrence or metastasis 2) severe physical or psychiatric symptoms 3) other clinical decisions
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Miyako Middle name Last name TAKAHASHI
Organization	Center for Cancer Control and Information Services, National Cancer Center
Division name	Division of Cancer Survivorship Research
Zip code	1040045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3547-5201
Email	miyataka@ncc.go.jp

Public contact
Name of contact person	1st name Makiko Middle name Last name TOMITA
Organization	Center for Cancer Control and Information Services, National Cancer Center
Division name	Division of Cancer Survivorship Research
Zip code	1040045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3547-5201
Homepage URL
Email	matomita@ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of National Cancer Center
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.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	国立がん研究センター中央病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 03 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	Completed
Date of protocol fixation	2018 Year 01 Month 12 Day
Date of IRB	2018 Year 01 Month 17 Day
Anticipated trial start date	2018 Year 02 Month 05 Day
Last follow-up date	2018 Year 08 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 02 Month 02 Day
Last modified on	2020 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035531