UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063182 |
|---|---|
| Receipt number | R000072311 |
| Scientific Title | Effect of Emotional Companion Robots on Patient-Reported Outcomes in Patients With Cancer Living Alone and Receiving Outpatient Treatment |
| Date of disclosure of the study information | 2026/10/07 |
| Last modified on | 2026/10/07 13:19:47 |
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Basic information
Public title
Effect of Emotional Companion Robots on Patient-Reported Outcomes in Patients With Cancer Living Alone and Receiving Outpatient Treatment
Acronym
HUG-CARE study
Scientific Title
Effect of Emotional Companion Robots on Patient-Reported Outcomes in Patients With Cancer Living Alone and Receiving Outpatient Treatment
Scientific Title:Acronym
HUG-CARE study
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to prospectively evaluate, using patient-reported outcomes (PROs), how the subjective experiences of patients with cancer who live alone and are receiving outpatient cancer treatment change after LOVOT is introduced into their daily lives as an emotional companion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to week 8 in the UCLA Loneliness Scale (Version 3) score
Key secondary outcomes
Change from baseline to week 8 in the Hospital Anxiety and Depression Scale (HADS) scores
Change from baseline to week 8 in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A family robot will be introduced into each participant's home for 8 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be eligible for enrollment:
1. Receiving outpatient systemic anticancer therapy for a malignant neoplasm
2. Aged 18 to 75 years (inclusive) on the date of enrollment
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
4. Judged by the attending physician to be able to continue study participation for 8 weeks
5. Living primarily alone in daily life
6. Not currently keeping a dog, cat, or any other pet
7. Having an internet connection at home and owning a smartphone
8. Providing written informed consent to participate in this study
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
1. Judged by the attending physician to be at high risk of acute deterioration or emergency hospitalization during the study period
2. Unable to use the robot because of visual impairment, paralysis or muscle weakness of the limbs, cognitive impairment, or other conditions
3. Having a comorbid psychiatric disorder or psychiatric symptoms that interfere with daily life and make study participation difficult
4. Using medical equipment with cords or tubing in the home, such as home oxygen therapy, such that the robot's movement could compromise safety
5. Otherwise judged by the attending physician to be unsuitable for study participation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenro |
| Middle name | |
| Last name | Hirata |
Organization
Keio University Hospital
Division name
cancer center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3790
amikato0127@keio.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Kato |
Organization
Keio University Hospital
Division name
Department of Gastroenterology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3790
Homepage URL
amikato0127@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Ami Kato
Funding Source
Organization
Keio University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Hospital
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
amikato0127@keio.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2026-1097
Org. issuing International ID_1
Keio University Hospital
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 | 07 | 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 | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 10 | 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 | 10 | Month | 05 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072311
