Unique ID issued by UMIN | UMIN000017621 |
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Receipt number | 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 | 2021/05/24 11:39:17 |
Construction of a nursing system leading to improvement in QOL of total laryngectomy patients: Longitudinal intervention by RCT
Construction of a nursing system to improvement in QOL of total laryngectomy patients
Construction of a nursing system leading to improvement in QOL of total laryngectomy patients: Longitudinal intervention by RCT
Construction of a nursing system to improvement in QOL of total laryngectomy patients
Japan |
laryngeal and pharyngeal cancer
Oto-rhino-laryngology | Nursing |
Malignancy
NO
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.
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.
Confirmatory
Pragmatic
Phase III
Quality of life and psychological adjustment in laryngectomized patients from hospital dishcharge to 3 months after the dischaege
Quality of life and psychological adjustment in laryngectomized patients from before surgery to one year after hospital dischaege
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
No treatment
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Numbered container method
2
Treatment
Behavior,custom | Other |
Informational supports using guidebook
Interview and consultation:face to face and informational supports using guidebook and a emergency call card
20 | years-old | <= |
Not applicable |
Male and Female
Patients who undergo laryngectomy by laryngeal and pharyngealcancer
(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
300
1st name | KUMIKO |
Middle name | |
Last name | KOTAKE |
Nara Medical University Faculty of Nursing
Home Care Nursing
634-8521
840 Shijo-cho Kashihara, Nara
0744-29-8946
kktoake@naramed-u.ac.jp
1st name | KUMIKO |
Middle name | |
Last name | KOTAKE |
SoS-PAL
Nara Medical University Faculty of Nursing
634-8521
840 Shijo-cho Kashihara, Nara
0477-29-8946
kkotake@naramed-u.ac.jp
Nara Medical University
Faculity of Nursing
Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research, Scientific Research (B)(General)
Japanese Governmental office
Japan
IRB
840 Shijo-cho Kashihara, Nara
0744-22-3051
ino-rinri@naramed-u.ac.jp
NO
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
2015 | Year | 05 | Month | 19 | Day |
Partially published
Open public recruiting
2015 | Year | 04 | Month | 01 | Day |
2019 | Year | 07 | Month | 17 | Day |
2019 | Year | 04 | Month | 01 | Day |
2023 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 19 | Day |
2021 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020415
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