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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | |||
Condition | laryngeal and pharyngeal cancer | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 | ||||||
kktoake@naramed-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
Registered date |
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Last modified on |
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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 | |
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