UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060025 |
|---|---|
| Receipt number | R000065939 |
| Scientific Title | Non-equivant Control Group Pre-Post study of a Delirium Prevention Nursing Care Program to Promote Cognitive Activity in Elderly Cancer Patients |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/12/09 12:48:24 |
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Basic information
Public title
Intervention for Nurses Implementing a Delirium Prevention Nursing Care Program Promoting Cognitive Activities in Elderly Cancer Patients: A Single-Group Feasibility Trial
Acronym
iCAN study
Scientific Title
Non-equivant Control Group Pre-Post study of a Delirium Prevention Nursing Care Program to Promote Cognitive Activity in Elderly Cancer Patients
Scientific Title:Acronym
iCAN study
Region
| Japan |
Condition
Condition
Nurse
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the effectiveness of a delirium prevention nursing care program designed to promote engaging cognitive activities for elderly cancer patients, specifically focusing on its impact on nurse education.
Basic objectives2
Others
Basic objectives -Others
Effects of Implementing a Delirium Prevention Nursing Care Program
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Implementation Rate of the Nurse's Delirium Prevention Nursing Care Program
Key secondary outcomes
Implementation rate of delirium prevention nursing care programs for patientsPercentage of delirium onset
Days to onset of delirium
Days to onset of delirium
Hospitalization days
Number of cases of self-extraction of tubes and falls
Incidence of physical restraints and number of days used
Percentage of patients discharged home
ADL at discharge
Use of new antipsychotic drugs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Upon admission, patients at high risk for delirium should be identified, patients at high risk for delirium should be briefed about delirium, and delirium symptoms should be assessed at least once a day using the Nu-DESC. The following preventive care for delirium is provided, but implementation is left to the judgment of each nurse in the course of daily medical care.
Interventions/Control_2
Trained nurses encourage cognitive activities in patients during hospitalization as a measure to prevent delirium.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses working in the designated wards
Key exclusion criteria
Nurses who transferred from the target ward due to retirement or other reasons before the end of the post group
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Chiyuki |
| Middle name | |
| Last name | Sasaki |
Organization
National Cancer Center Hospital
Division name
Nursing Department
Zip code
104-0045
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo 104-0045,Japan
TEL
03-3542-2511
cterada@ncc.go.jp
Public contact
Name of contact person
| 1st name | Chiyuki |
| Middle name | |
| Last name | Sasaki |
Organization
National Cancer Center Hospital
Division name
Nursing Department
Zip code
104-0045
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo 104-0045,Japan
TEL
03-3542-2511
Homepage URL
cterada@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
NAKANISHI MUTSUKO NURSING PRACTICE RESEARCH FUND
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of National Cancer Center, Japan
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065939
