UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063192 |
|---|---|
| Receipt number | R000072317 |
| Scientific Title | Effects of a Death Cafe Intervention Among Nurses: A Randomized Controlled Trial With Post-intervention Interviews |
| Date of disclosure of the study information | 2026/10/06 |
| Last modified on | 2026/10/06 16:47:43 |
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Basic information
Public title
Effects of a Death Cafe Intervention Among Nurses: A Randomized Controlled Trial With Post-intervention Interviews
Acronym
Death Cafe RCT for Nurses
Scientific Title
Effects of a Death Cafe Intervention Among Nurses: A Randomized Controlled Trial With Post-intervention Interviews
Scientific Title:Acronym
Death Cafe RCT for Nurses
Region
| Japan |
Condition
Condition
Nurses (not a disease-specific study)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate the effects of a Death Cafe intervention on terminal care attitudes among nurses working at a single acute care hospital in Japan through a randomized controlled trial. Secondary exploratory objectives are to examine changes in each subscale score of the Death Attitude Inventory (DAI) and associations between these changes and changes in terminal care attitudes. In addition, post-intervention focus group interviews and free-text questionnaire responses will be used to explore participants' experiences of dialogue and insights, providing a complementary understanding of the context and meaning of the quantitative findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The between-group difference in the change in FATCOD-BJ total score from baseline (one week before the Death Cafe intervention) to one month after the intervention.
Assessments in the control group will follow the same schedule relative to a prespecified corresponding Death Cafe date.
Key secondary outcomes
1. The between-group difference in the change in FATCOD-BJ total score from baseline to one week after the intervention.
2. Between-group differences in changes in each Death Attitude Inventory subscale score from baseline to one week and one month after the intervention.
3. Associations between changes from baseline in each Death Attitude Inventory subscale score and changes in FATCOD-BJ total score at one week and one month after the intervention.
4. Qualitative findings regarding participation experiences, insights, and perspectives on life, death, and terminal care, obtained from focus group interviews immediately after the Death Cafe and free-text questionnaire responses at one week and one month after the intervention in the intervention group.
Baseline assessments will be conducted one week before the intervention. Control-group questionnaires will follow the same schedule relative to a prespecified corresponding Death Cafe date. Between-group comparisons of Death Attitude Inventory subscale scores and analyses of associations between score changes will be exploratory.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group (Group A):
Each participant will attend one approximately 60-minute Death Cafe session involving participant-led dialogue about death and life. Each group will normally comprise five participants, with adjustments to four to six participants as needed. The session will consist of a five-minute introduction and explanation of ground rules, 50 minutes of dialogue, and a five-minute closing. The same facilitator will conduct all sessions using a predefined discussion theme and a facilitation checklist.
One approximately 60-minute focus group interview will be conducted for evaluation purposes on the same day after the Death Cafe. Both the Death Cafe and the interview will be audio-recorded.
Questionnaires will be administered one week before, one week after, and one month after the Death Cafe.
Interventions/Control_2
Control group (Group B):
Participants will continue their usual work and daily activities without receiving a study-provided Death Cafe session or focus group interview during the comparative assessment period.
The same questionnaires as those used in the intervention group will be administered at three time points: one week before, one week after, and one month after a prespecified corresponding Death Cafe date.
After the study period ends, participants who wish to attend will be offered an opportunity to participate in a Death Cafe.
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 employed at the participating acute care hospital in Japan.
2. Previous experience of participating in a death conference.
3. Ability to understand the purpose and procedures of the study and provision of voluntary written informed consent.
Key exclusion criteria
1. Individuals judged by the investigator to be at risk of substantial psychological distress from participation in research concerning terminal care. Eligibility will be determined in consultation with the individual, using an individual consultation and the K6 psychological distress scale as needed.
2. Individuals planning to take a leave of absence or leave their employment during the data collection period.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | AYAKO |
| Middle name | |
| Last name | KAMIYA |
Organization
National Defense Medical College
Division name
Department of Nursing
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
04-2995-1211
a-kamiya@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | AYAKO |
| Middle name | |
| Last name | KAMIYA |
Organization
National Defense Medical College
Division name
Department of Nursing
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
04-2995-1211
Homepage URL
a-kamiya@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
AYAKO KAMIYA
Funding Source
Organization
Self-funded by the principal investigator
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
National Defense Medical College
Address
3-2 Namiki, Tokorozawa, Saitama
Tel
04-2995-1211
a-kamiya@ndmc.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 | 10 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2027 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2027 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2027 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 10 | Month | 06 | Day |
Last modified on
| 2026 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072317
