UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062736 |
|---|---|
| Receipt number | R000071835 |
| Scientific Title | A multicenter, single-arm feasibility study on the usefulness of life review for terminally ill patients with cancer using image-generating AI |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/30 11:07:06 |
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Basic information
Public title
A multicenter, single-arm feasibility study on the usefulness of life review for terminally ill patients with cancer using image-generating AI
Acronym
Feasibility study on life reviews using generative AI
Scientific Title
A multicenter, single-arm feasibility study on the usefulness of life review for terminally ill patients with cancer using image-generating AI
Scientific Title:Acronym
Life review for terminally ill cancer patients using image-generating AI: A multicenter feasibility study
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a new life review method utilizing image-generating artificial intelligence (AI) for terminally ill cancer patients hospitalized in a palliative care unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the total STAI-Y-1 score before and after the intervention
Key secondary outcomes
1) Changes in ESAS-r-J scores before and after the intervention
2) NRS scores regarding nostalgia and similarity to the image
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1) Have the research participants complete the State-Trait Anxiety Inventory Y-1 (STAI Y-1) and the Japanese version of the Edmonton Symptom Assessment Scale-Revised (ESAS-r-J).
2) Participants are asked to select one topic of their choice from the conversation topics provided by the image-generating AI app.
3) A conversation is conducted based on the topic selected by the participant.
4) After the conversation ends, the generated image [a color still image, an illustration with a soft, delicate touch resembling a watercolor or colored pencil drawing] will be printed and given to the research participant, who will then complete the STAI Y-1 and ESAS-r-J questionnaires again. In addition, participants are asked to respond to the questions Did you feel a sense of nostalgia? and Was the generated image close to what you had in mind? using an 11-point Numerical Rating Scale (NRS) (0: Not at all to 10: Very much so). If the generated image differs from the participant's mental image and the image is regenerated, the evaluation using the above NRS shall be conducted only for the image the participant ultimately accepted (the last image generated), rather than as an overall assessment of all generated images.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 18 years of age or older
2) A cancer patient currently hospitalized in a palliative care unit
3) Able to complete the questionnaire
4) Written informed consent has been obtained from the participant regarding participation in this study
Key exclusion criteria
1) Individuals who have been diagnosed with dementia.
2) Individuals whom the principal investigator or a co-investigator has determined are unsuitable to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ohno |
Organization
Shimane University Hospital
Division name
Palliative Care Center
Zip code
693-8501
Address
89-1 Shioya-cho, Izumo City, Shimane Prefecture
TEL
0853-88-3057
ohno55@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Niki |
Organization
The University of Osaka
Division name
Graduate School of Pharmaceutical Sciences
Zip code
565-0871
Address
1-6, Yamada-oka, Suita-shi, Osaka Prefecture
TEL
06-6879-8250
Homepage URL
niki.kazuyuki.phs@osaka-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Shimane University Committee on Medical Research Ethics
Address
89-1 Shioya-cho, Izumo City, Shimane Prefecture
Tel
0853-20-2259
kenkyu@med.shimane-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
| 2026 | Year | 08 | Month | 31 | 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 | 07 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 30 | Day |
Last modified on
| 2026 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071835
