Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062736) titled 'A multicenter, single-arm feasibility study on the usefulness of life review for terminally ill patients with cancer using image-generating AI' on Aug. 31.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Shimane University

Condition: Condition - cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 20

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071835

Disclaimer: Curated by HT Syndication.