Tokyo, April 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061135) titled 'A Multigroup Comparative Study on Changes in Mood States among Cancer Survivors' on April 3.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - National Cancer Center

Condition: Condition - Cancer survivors within 5 years of diagnosis Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to examine changes in mood states among cancer survivors using a multigroup comparative design, focusing on different non-pharmacological approaches such as music, relaxation, and exercise. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Automatically generated music: Listening to automatically generated music for 15 minutes. In this study, an intervention using the automatically generated music application soundtope will be implemented. soundtope is a music application developed based on an automated composition system modeled on natural phenomena and is designed to alleviate the tension associated with overly quiet environments. It was also developed to examine the mood-enhancing effects of music. Unlike conventional music, it generates continuously evolving, non-repetitive, organically changing sound in real time. In addition, the application allows users to adjust sound parameters according to their preferences, enabling a personalized intervention. Participants in this study will listen to soundtope for 15 minutes. Interventions/Control_2 - Progressive muscle relaxation: Performing progressive muscle relaxation for 15 minutes. Progressive muscle relaxation is a method that promotes psychological and physical relaxation by increasing awareness of muscle tension through the sequential contraction and relaxation of muscle groups throughout the body. The intervention will be conducted in a seated position using a chair. As an introduction, diaphragmatic breathing will be performed to regulate breathing, followed by the PMR procedure. Muscle groups including the upper limbs, face/neck/shoulders, trunk, and lower limbs will be sequentially tensed at approximately 60-70% of maximal effort for a short duration and then rapidly relaxed.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1)Diagnosed with cancer within the past 5 years. (2)Aged 18 years or older. (3)Able to read and write in Japanese. (4)Able to understand the study and provide informed consent. Key exclusion criteria - (1)Judged by the investigator to be unable to participate in the study due to physical or psychological conditions. (2)Having hearing impairment and routinely using assistive devices such as hearing aids. (3)Currently receiving treatment for a psychiatric disorder. (4)Advised by a physician to restrict physical activity. (5)Judged to have difficulty safely performing light exercise in place due to gait impairment or other physical limitations. Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 02 Day Date of IRB - 2026 Year 04 Month 02 Day Anticipated trial start date - 2026 Year 04 Month 10 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=R000069946

Disclaimer: Curated by HT Syndication.