UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052812 |
|---|---|
| Receipt number | R000060273 |
| Scientific Title | A Web-based Educational Program to Improve Nurses' Ability to Assess Cancer Cachexia: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2023/11/16 10:30:27 |
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Basic information
Public title
A Web-based Educational Program to Improve Nurses' Ability to Assess Cancer Cachexia: A Pilot Randomized Controlled Trial
Acronym
Cancer Cachexia Nursing Education Program: A Pilot Randomized Controlled Trial
Scientific Title
A Web-based Educational Program to Improve Nurses' Ability to Assess Cancer Cachexia: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
Cancer Cachexia Nursing Education Program: A Pilot Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Nurses involved in the care of patients with advanced cancer who are undergoing cancer drug therapy.
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility and acceptability of a nursing education program that provides basic knowledge of cancer cachexia and strategies for comprehensive assessment of cancer cachexia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of the educational program (after 4 weeks)
Key secondary outcomes
1) Follow-up rates of the educational program (at intervention and after 2 weeks)
2) Acceptability of the educational program (after 4 weeks)
3) Capability (at intervention, after 2 and 4 weeks)
4) Opportunity (at intervention, after 2 and 4 weeks)
5) Motivation (at intervention, after 2 and 4 weeks)
6) Behavior (at intervention, after 2 and 4 weeks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The intervention group will take the cancer cachexia nursing education program (e-learning) in two weeks.
Interventions/Control_2
The control group will not take the cancer cachexia nursing education program.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are nurses who
1) belong to designated cancer hospitals in Tokyo, Kanagawa, and Saitama prefectures.
2) work in the wards or outpatient departments of respiratory or gastroenterology and outpatient treatment centers.
3) involved in the care of patients with advanced cancer who are undergoing cancer drug therapy.
4) over 18 years of age.
5) No restrictions on position, years of clinical experience, or qualifications.
Key exclusion criteria
Managers (e.g., head nurses) who are not directly involved in patient care were excluded from the study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Rika |
| Middle name | |
| Last name | Sato |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
411-8777
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
03-3543-6391
21dn005@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Sato |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
03-3543-6391
Homepage URL
21dn005@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
03-5550-2423
kenkyukikaku@luke.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 06 | 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
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060273
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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