UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017621 |
|---|---|
| Receipt number | R000020415 |
| Scientific Title | Construction of a nursing system leads to improvement in QOL of laryngectomized patients: Longitudinal nursing intervention using RCT |
| Date of disclosure of the study information | 2015/05/19 |
| Last modified on | 2026/05/26 10:22:43 |
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Basic information
Public title
Construction of a nursing system leading to improvement in QOL of total laryngectomy patients: Longitudinal nursing intervention using RCT
Acronym
Construction of a nursing system to improvement in QOL of patients from before surgery to 12 months after hospital discharge
Scientific Title
Construction of a nursing system leads to improvement in QOL of laryngectomized patients: Longitudinal nursing intervention using RCT
Scientific Title:Acronym
Construction of a nursing system to improvement in QOL of laryngectomized 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
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
0477-29-8946
Homepage URL
kkotake@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Faculity of Nursing
Institute
Department
Personal name
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
| 2015 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
UMIN0000176217
Publication of results
Partially published
Result
URL related to results and publications
UMIN0000176217
Number of participants that the trial has enrolled
73
Results
In terms of the effects of the primary purpose nursing intervention, there was a difference in the RP, SF, and RE scores of the intervention group compared to the control group at 3 months after discharge. The intervention group scored 33, 33.7, and 35.4 points, a difference of more than 10 points for each group.Three months after discharge, all scores were still above 40 except for RP, SF, and RE.
Results date posted
| 2026 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The preoperative age of the 3 patients in the intervention group for total laryngectomy averaged 75.3 years, 5 in the control group, 74.8 years, and the 30 patients in the intervention group for extensive surgery averaged 69.5 years, 23 in the control group, 68.5 years (Table 1). There was a group for which the surgical method was unknown: 5 patients in the intervention group, with a mean age of 69.2 years, and 7 patients in the control group, with a mean age of 71.9 years. There were 8 patients who underwent only total laryngectomy and 53 patients who underwent extensive surgery, most of whom underwent extensive surgery.
Participant flow
Intervention Group
Patients who were scheduled to undergo total laryngectomy and who had received an explanation of the study and provided informed consent received the guidebook after enrollment. A nurse conducted an interview based on the guidebook. Following the interview, a questionnaire was distributed, and participants completed it and returned it to the nurse.
Before discharge, another nurse-led interview based on the guidebook was conducted. Participants then received a questionnaire, which they completed and returned by mail after discharge.
At 3, 6, and 12 months after discharge, participants attended outpatient follow-up interviews conducted by a nurse. During these interviews, the nurse used the guidebook to assess any difficulties participants were experiencing in their daily lives. Questionnaires were also mailed to participants at each follow-up point. Participants completed the questionnaires and returned them by mail.
Control Group
Patients in the control group received the guidebook before surgery and received usual care until 12 months after discharge.
Questionnaires were mailed to participants before discharge and at 3, 6, and 12 months after discharge. Participants completed the questionnaires and returned them by mail.
A follow-up interview was conducted at 12 months after discharge.
Concise Version (for Methods Section)
Intervention group: After providing informed consent, participants received the guidebook and participated in nurse-led interviews based on the guidebook before surgery, before discharge, and at 3, 6, and 12 months after discharge. Questionnaires were administered at each assessment point.
Control group: Participants received the guidebook before surgery and received usual care until 12 months after discharge. Questionnaires were administered before discharge and at 3, 6, and 12 months after discharge, and a follow-up interview was conducted at 12 months after discharge.
Adverse events
Because some survey questions might have caused psychological distress or emotional burden, participants were informed that they were not required to answer any questions they found uncomfortable and could refrain from responding at any time. No adverse events related to study participation had occurred during the study period.
Outcome measures
QOL, SF-36
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
| 2026 | 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
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020415
