UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060749 |
|---|---|
| Receipt number | R000069514 |
| Scientific Title | Examination of the Utility of a Dialogue-Based Nursing Practice Model (Ver.2) for Sharing Meaningful Way of Living among Patients with Treatment-Resistant Illness |
| Date of disclosure of the study information | 2026/02/25 |
| Last modified on | 2026/02/25 23:02:28 |
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Basic information
Public title
Examination of the Utility of a Dialogue-Based Nursing Practice Model (Ver.2) for Sharing Meaningful Way of Living among Patients with Treatment-Resistant Illness
Acronym
Dialogue-Based Nursing Practice Model Ver.2 Utility Study
Scientific Title
Examination of the Utility of a Dialogue-Based Nursing Practice Model (Ver.2) for Sharing Meaningful Way of Living among Patients with Treatment-Resistant Illness
Scientific Title:Acronym
Dialogue-Based Nursing Practice Model Ver.2 Utility Study
Region
| Japan |
Condition
Condition
Treatment-resistant illness (including cancer and non-cancer)
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Infectious disease | Geriatrics |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Ophthalmology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Radiology | Oral surgery | Neurosurgery |
| Cardiovascular surgery | Plastic surgery | Emergency medicine |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of implementing a Dialogue-Based Nursing Practice Model (Ver.2) for sharing meaningful way of living among patients with treatment-resistant illness, focusing on improving patient satisfaction and enhancing general nurses' communication skills.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
[Patients] Patient satisfaction and dialogue experience after implementing the Dialogue-Based Nursing Practice Model (Ver.2): Rogers' Empathic Listening Scale (speaker version), researcher-developed items, and semi-structured interviews; within 7 days after the final dialogue.
[Nurses] Communication skills and practice changes: Rogers' Empathic Listening Scale (listener version), Communication Skills Scale for End-of-Life Care Nurses, Knowledge/Practice/Difficulty Scale for Palliative Care Providers (partial), Difficulty Scale for Cancer Nursing (partial), and semi-structured interviews; within 7 days after the final dialogue.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
General nurses conduct dialogues with patients with treatment-resistant illness using the Dialogue-Based Nursing Practice Model (Ver.2). The dialogues are conducted multiple times during hospitalization (approximately 3 times as a guide), through a process of attentively receiving and clarifying the patient's meaningful way of living, and sharing it between the patient and healthcare providers.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Patients] 1) Aged 20 years or older and capable of communicating their own wishes; 2) In a physical and mental condition that allows dialogues of approximately 30 minutes; 3) Diagnosed with treatment-resistant illness and having received explanations from a physician regarding their condition, current treatment, and treatment goals; 4) For cancer patients: judged by a physician as relapsed/refractory, undergoing 3 or more lines of treatment regimens, or hospitalized due to poorly controlled complications; for non-cancer patients: judged by a physician as relapsed/refractory or repeatedly hospitalized in a declining phase.
[Nurses] 1) Ward nurses with at least 2 full years of experience in the same ward and at least 3 years of overall nursing experience; 2) Having attained Japanese Nursing Association Clinical Ladder (2023 revised edition) Level I or above.
Key exclusion criteria
[Patients] 1) Unable to communicate their own wishes due to impaired consciousness or cognitive decline; 2) In a physical or mental condition that makes 30-minute dialogues difficult; 3) Those whose attending physician judges participation to be inappropriate based on the patient's understanding of their medical condition; 4) Those who do not provide informed consent for participation; 5) Those judged by the researcher or attending nurse as unsuitable for participation.
[Nurses] 1) Those who do not provide informed consent for participation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Matsuyama |
Organization
Graduate School of Nursing, Chiba University
Division name
Doctoral Program, Major in Nursing
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
0757514629
naomi_m@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Matsuyama |
Organization
Graduate School of Nursing, Chiba University
Division name
Doctoral Program, Major in Nursing
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
0757514629
Homepage URL
naomi_m@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Ethics Review Committee, Graduate School of Nursing, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8672, Japan
Tel
0432262496
kango-rinnri@chiba-u.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 | 02 | Month | 25 | 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 | 16 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 09 | 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
| 2026 | Year | 02 | Month | 25 | Day |
Last modified on
| 2026 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069514
