Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063182) titled 'Effect of Emotional Companion Robots on Patient-Reported Outcomes in Patients With Cancer Living Alone and Receiving Outpatient Treatment' on Oct. 7.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Keio University Hospital
Condition:
Condition - cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - A family robot will be introduced into each participant's home for 8 weeks.
Eligibility:
Age-lower limit - 18
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 Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 10 Month 05 Day
Anticipated trial start date - 2026 Year 10 Month 30 Day
Last follow-up date - 2029 Year 10 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072311
Disclaimer: Curated by HT Syndication.
