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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017621
Receipt No. R000020415
Scientific Title Construction of a nursing system leading to improvement in QOL of total laryngectomy patients: Longitudinal intervention by RCT
Date of disclosure of the study information 2015/05/19
Last modified on 2020/06/03

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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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