UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effectiveness by the rehabilitation introduction in the gynecology cancer patient
Title of the study (Brief title)	Effect of the rehabilitation in the gynecology cancer patient
Region	Japan

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

Objectives
Narrative objectives1	Effect of the rehabilitation in the gynecology cancer patient
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL,fatigue, depressive symptom
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	rehabilitation
Interventions/Control_2	Rehabilitation non-enforcement group
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Gynecology cancer patient
Key exclusion criteria	High-risk
Target sample size	40

Research contact person
Name of lead principal investigator	RYO NAGATA
Organization	Comprehensive cancer Center Yokohama City University Mdical Center
Division name	palliative care
Address	4-57 Urafune Minami-ku Yokohama-shi
TEL	045-261-5656
Email	r_nagata@yokohama-cu.ac.jp

Public contact
Name of contact person	RYO NAGATA
Organization	Comprehensive cancer Center Yokohama City University Mdical Center
Division name	palliative care
Address	4-57 Urafune Minami-ku Yokohama-shi
TEL	045-261-565+6
Homepage URL
Email	r_nagata@yokohama-cu.ac.jp

Sponsor
Institute	Comprehensive cancer Center Yokohama City University Mdical Center
Institute
Department

Funding Source
Organization	Comprehensive cancer Center Yokohama City University Mdical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 05 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 04 Month 30 Day
Anticipated trial start date	2017 Year 05 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 14 Day
Last modified on	2017 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030955