UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060516 |
|---|---|
| Receipt number | R000069036 |
| Scientific Title | A Web-based Educational Program to Improve Visiting Nurses' Cancer Pain Management Skills: Feasibility of a Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/30 09:44:23 |
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Basic information
Public title
A Study to Evaluate the Feasibility of a Cancer Pain Management Education Program for Visiting Nurses
Acronym
Visiting Nurse Cancer Pain Education Study
Scientific Title
A Web-based Educational Program to Improve Visiting Nurses' Cancer Pain Management Skills: Feasibility of a Pilot Randomized Controlled Trial
Scientific Title:Acronym
Cancer Pain Management Education Program for Visiting Nurses: Pilot RCT
Region
| Japan |
Condition
Condition
Cancer Pain
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility of a randomized controlled trial using an educational program for visiting nurses aimed at improving cancer pain management skills.
Basic objectives2
Others
Basic objectives -Others
To assess the feasibility of a cancer pain management educational program for visiting nurses.
To evaluate the acceptability of the educational program.
To exploratorily assess changes in Theory of Planned Behavior based psychosocial determinants related to cancer pain management.
To exploratorily assess changes in the frequency of cancer pain management nursing practices.
To exploratorily assess changes in knowledge of cancer pain and opioid use.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of the educational program
Key secondary outcomes
1.Acceptability of the educational program
2.Theory of Planned Behavior based psychosocial determinants of cancer pain management
3.Frequency of cancer pain management nursing practices
4.Knowledge of Cancer Pain and Opioids
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Web-based cancer pain management educational program
Participants in the intervention group will receive a web-based educational program consisting of video materials, an e-learning platform, a workbook, and group discussions.
Interventions/Control_2
Standard education (text-based materials)
Participants in the control group will receive text-based educational materials on cancer pain management and will not have access to the web-based educational 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Applicants must meet all of the following criteria:
1) Home-visit nurses with at least six months but less than ten years of experience who do not hold certification as a Certified Cancer Nurse or Certified Palliative Care Nurse
2) Have experience providing home visits to patients with cancer pain
3) Are able to complete a web-based questionnaire
Key exclusion criteria
Individuals falling under any of the following categories shall not be included in this study:
1) Facility administrators or department heads
2) Certified or specialized nurses qualified in cancer nursing
3) Individuals with difficulty reading, writing, or communicating in Japanese
4) Individuals without a nursing license
5) Individuals unable to view videos or e-learning content
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Okimura |
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
TEL
0335436391
22DN005@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Okimura |
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
TEL
0355502341
Homepage URL
22DN005@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
St. Luke's International University
Address
10-1, Akashi-cho, Chuo-ku, Tokyo
Tel
0335436391
22DN005@slcn.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
| 2026 | Year | 01 | Month | 30 | 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
| 2026 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069036
