UMIN-CTR Clinical Trial

Basic information
Public title	Construction of a nursing system leading to improvement in QOL of total laryngectomy patients: Longitudinal intervention by RCT
Acronym	Construction of a nursing system to improvement in QOL of total laryngectomy patients
Scientific Title	Construction of a nursing system leading to improvement in QOL of total laryngectomy patients: Longitudinal intervention by RCT
Scientific Title:Acronym	Construction of a nursing system to improvement in QOL of total laryngectomy patients
Region	Japan

Condition
Condition	laryngeal and pharyngeal cancer
Classification by specialty	Oto-rhino-laryngology Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effects of regular informational and psychological nursing interventions from before the surgery to one year after discharge in a Randomized Controlled Trial in order to improve the quality of life of laryngectomized patients.We aim to establish a nursing system that can support seamlessly to live in peace even after discharge from the hospital. Primary Outcome (Phase III) It is clarified that psychological adjustment and QOL of laryngectomized patients can be maintained and improved without decline compared with information provision only before and 3 months after discharge from hospital.
Basic objectives2	Others
Basic objectives -Others	Secondary Outcome It is clarified that psychological adjustment and quality of life can continue to improve up to one year after hosipital discharge in comparison with informational and psychological nursing intervention and information provision only. It is clarified that informative and psychological support at when stage of the process from psychological adjustment to social adjustment in laryngectomized paitents, and what informational support is effective.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Quality of life and psychological adjustment in laryngectomized patients from hospital dishcharge to 3 months after the dischaege
Key secondary outcomes	Quality of life and psychological adjustment in laryngectomized patients from before surgery to one year after hospital dischaege

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Other
Interventions/Control_1	Informational supports using guidebook
Interventions/Control_2	Interview and consultation:face to face and informational supports using guidebook and a emergency call card
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	Male and Female
Key inclusion criteria	Patients who undergo laryngectomy by laryngeal and pharyngealcancer
Key exclusion criteria	(1)disagree (2)difficult answer the questionnaire because of bad physical condition (3)difficult read the questionnaire because of visual impairment etc. (4)difficult answer the questionnaire for the other reason (5)died (6)difficult answer for some reason (7)address unknown
Target sample size	300

Research contact person
Name of lead principal investigator	1st name KUMIKO Middle name Last name KOTAKE
Organization	Nara Medical University Faculty of Nursing
Division name	Home Care Nursing
Zip code	634-8521
Address	840 Shijo-cho Kashihara, Nara
TEL	0744-29-8946
Email	kktoake@naramed-u.ac.jp

Public contact
Name of contact person	1st name KUMIKO Middle name Last name KOTAKE
Organization	SoS-PAL
Division name	Nara Medical University Faculty of Nursing
Zip code	634-8521
Address	840 Shijo-cho Kashihara, Nara
TEL	047-350-4016
Homepage URL
Email	kkotake@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University Faculity of Nursing
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research, Scientific Research (B)(General)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	IRB
Address	840 Shijo-cho Kashihara, Nara
Tel	0744-22-3051
Email	ino-rinri@naramed-u.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	福岡大学病院（福岡県）、九州大学病院（福岡県）、久留米大学病院（福岡県）、九州がんセンター（福岡県） 奈良県立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 19 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Open public recruiting
Date of protocol fixation	2015 Year 04 Month 01 Day
Date of IRB	2019 Year 07 Month 17 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2023 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	2015 Year 05 Month 19 Day
Last modified on	2020 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020415

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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