UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031113 |
|---|---|
| Receipt number | R000035531 |
| Scientific Title | Feasibility study of evaluating health behavior support system with leaflet distribution for women with gynecological cancer. |
| Date of disclosure of the study information | 2018/02/03 |
| Last modified on | 2020/03/30 17:47:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
matomita@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035531
