UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052329 |
|---|---|
| Receipt number | R000058109 |
| Scientific Title | Evidence-Practice GAP (E-P GAP) Study |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/03/29 11:01:31 |
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Basic information
Public title
Evidence-Practice GAP (E-P GAP) Study
Acronym
Evidence-Practice GAP (E-P GAP) Study
Scientific Title
Evidence-Practice GAP (E-P GAP) Study
Scientific Title:Acronym
Evidence-Practice GAP (E-P GAP) Study
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the gap between clinical practice and research evidence, we will survey nurses in hospice and palliative care units to determine their practice of nursing support for cancer-related symptoms experienced by patients with terminal cancer and the caregiver burden experienced by their families.
Basic objectives2
Others
Basic objectives -Others
Comparison of the implementation of each nursing support on a prognosis of months and weeks.
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 the Palliative Care Unit.
2) Nurses who provide direct care to inpatients in the Palliative Care Unit.
3) Full-time and part-time positions are not required.
4) Persons who have given consent to participate in this study.
Key exclusion criteria
1) Managers of the Palliative Care Unit (e.g., ward managers)
2) Nurses working as support (help) from other wards
3) Nurses from other hospitals who have come for training or practical training
Target sample size
1000
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
https://bridge-epgap.org/
jkako@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
KAKO JUN
Funding Source
Organization
JSPS KAKENHI
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
Mie University
Address
2-174 Edobashi, Tsu Sity, Mie
Tel
059-231-5246
coi-kenkyu@mo.medic.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
| 2023 | Year | 10 | 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
539
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The findings have already been published.
Management information
Registered date
| 2023 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058109
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/06/07 | E-P-GAP_研究計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/06/07 | データ症例仕様書(E-P GAP).pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/06/07 | GAP回答539名分_20240521.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/58109
