UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059078 |
|---|---|
| Receipt number | R000067578 |
| Scientific Title | Evidence-Practice GAP (E-P GAP) Study in General Wards |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/09/12 19:12:52 |
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Basic information
Public title
Evidence-Practice GAP (E-P GAP) Study in General Wards
Acronym
Evidence-Practice GAP (E-P GAP) Study in General Wards
Scientific Title
Evidence-Practice GAP (E-P GAP) Study in General Wards
Scientific Title:Acronym
Evidence-Practice GAP (E-P GAP) Study in General Wards
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the current status of nursing support provided to terminally ill cancer patients and their families by nurses working in general wards of designated cancer care hospitals and related institutions.
Basic objectives2
Others
Basic objectives -Others
Comparison with nursing support experiences during the past year
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of nursing support for each symptom (cancer pain, dyspnea, nausea/vomiting, caregiver burden, constipation, delirium)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1)Nurses working in general wards of designated cancer care hospitals or equivalent institutions
2)Providing direct care to hospitalized cancer patients in general wards
3)Both full-time and part-time employment statuses are eligible
)Written informed consent to participate in this study has been obtained
Key exclusion criteria
1)Ward managers (e.g., head nurses)
2)Nurses temporarily assigned from other wards for support (help)
3)Nurses or students from other hospitals who are participating in training or clinical practice
4)Nurses working in operating rooms, intensive care units (ICU, CCU), pediatric wards, orthopedic wards, psychiatric wards, or palliative care wards
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Kako |
Organization
Mie University
Division name
Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu City, Mie
TEL
059-231-5091
jkako@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Kako |
Organization
Mie University
Division name
Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu City, Mie
TEL
059-231-5091
Homepage URL
jkako@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
KAKO JUN
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University
Address
2-174 Edobashi, Tsu Sity, Mie
Tel
059-231-5246
kk-sien@med.mie-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 01 | 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
| 2025 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted as an internet-based questionnaire survey to collect the following items: background information (years of nursing experience, age, sex, highest educational attainment, qualifications, etc.), support experiences during the past year, and the implementation status of each type of support.
Management information
Registered date
| 2025 | Year | 09 | Month | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067578
