UMIN-CTR Clinical Trial

Basic information
Public title	Employment status of cervical cancer patient
Acronym	Employment status of cervical cancer patient
Scientific Title	Employment status of cervical cancer patient
Scientific Title:Acronym	Employment status of cervical cancer patient
Region	Japan

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

Objectives
Narrative objectives1	Survey on the actual condition of employment status of cervical cancer patients
Basic objectives2	Others
Basic objectives -Others	The relationship between employment status of cervical cancer and self-efficacy, self-esteem, dysfunction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Employment status of cervical cancer patient
Key secondary outcomes	1)The relationship between employment status of cervical cancer patient and self-efficacy 2) The relationship between employment status of cervical cancer patient and self-esteem 3) The relationship between employment status of cervical cancer patient and dysfunction

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Patient aged from 20 to 64 2)Patient who have undergone any of the following treatments for cervical cancer and have been 6 months to 5 years after the start of treatment (1) Cervical malignant tumor surgery and Lymph node dissection (including enforcement of adjuvant therapy) (2) Concurrent Chemoradiation Therapy(including enforcement of adjuvant therapy) 3) Patient who is judged by primary doctor 4) Patient who gained consent to participate in research
Key exclusion criteria	1) Patient who had a diagnosis of other cancers within 5 years 2) Patient with cognitive impairment or mental disorders 3) Patient with distant metastasis or recurrence 4) Patient who are undergoing treatment for cervical cancer 5) Those who cannot understand Japanese to complete the questionnaire
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Komatsu Hiroko
Organization	Keio University Graduate School of Health Management
Division name	Nursing
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL	03-5363-3733
Email	komah@sfc.keio.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Iijima Miho
Organization	Keio University Graduate School of Health Management
Division name	Nursing
Zip code
Address	4411 Endo, Fujisawa-shi, Kanagawa 252-0883 Japan
TEL	0466-49-6200
Homepage URL
Email	h17701mg@sfc.keio.ac.jp

Sponsor
Institute	Keio University Graduate School of Health Management
Institute
Department

Funding Source
Organization	Self funding
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
Address
Tel
Email

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	慶應義塾大学病院（東京都） Keio University hospital（Tokyo）

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 19 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 06 Month 25 Day
Date of IRB	2018 Year 06 Month 25 Day
Anticipated trial start date	2018 Year 08 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	Design: Observational cross-sectional study Measures 1)Self-efficacy 2)Self-esteem 3)Dysfunction

Management information
Registered date	2018 Year 07 Month 19 Day
Last modified on	2021 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038136