UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059012 |
|---|---|
| Receipt number | R000067094 |
| Scientific Title | A randomized waiting list control trial of the Effectiveness of the SEPP-CD |
| Date of disclosure of the study information | 2025/09/10 |
| Last modified on | 2025/09/05 18:14:45 |
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Basic information
Public title
Evaluation of the Effectiveness of Simulation-based Educational Program for Pain Management in Older Cancer Patients with Dementia
Acronym
Evaluation of the Effectiveness of the SEPP-CD Program
Scientific Title
A randomized waiting list control trial of the Effectiveness of the SEPP-CD
Scientific Title:Acronym
SEPP-CD-RWLC Trial
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to provide evidence of the effectiveness of the SEPP-CD educational program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-Report Scale of Nursing Practice in Pain Management for Older Patients with Cancer and Dementia
Nurses'Knowledge of Pain Management in Older Adults with Cancer and Dementia
Key secondary outcomes
Perceived Difficulties in Pain Management for Older Cancer Patients with Dementia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Simulation-based Educational Program for Pain Management in Older Cancer Patients with Dementia
Interventions/Control_2
Non-intervention group
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 with Clinical Ladder Level II or higher who have experience in caring for older cancer patients with dementia
Key exclusion criteria
NO
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | mikiko |
| Middle name | |
| Last name | kawamura |
Organization
Sapporo City University
Division name
School of Nursing
Zip code
0600011
Address
kita11,Nishi13,chuo-ku,sapporo
TEL
011-726-2539
m.kawamura@scu.ac.jp
Public contact
Name of contact person
| 1st name | Mikiko |
| Middle name | |
| Last name | Kawamura |
Organization
Sapporo City University
Division name
School of Nursing
Zip code
0600011
Address
kita11,Nishi13,chuo-ku,sapporo
TEL
011-726-2539
Homepage URL
m.kawamura@scu.ac.jp
Sponsor or person
Institute
Sapporo City University
Institute
Department
Personal name
Funding Source
Organization
Sapporo City University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo City University
Address
kita11,Nishi13,chuo-ku,sapporo
Tel
011-726-2539
m.kawamura@scu.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
北海道
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 10 | 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 | 08 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | 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 | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067094
