Clinical Trial: An Exploratory Study on Estimating Physical and Mental Health Status and Developing a Novel State Assessment Indicator Based on Daily Rhythms and Medication Data in Cancer Survivors (Japan)

Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057685) titled 'Estimation of Physical and Mental Health and Development of a Novel State Indicator Based on Daily Rhythms and Medication Data in Cancer Survivors: An Exploratory Study' on Dec. 31.

Study Type: Observational

Primary Sponsor: Institute - Humanome Lab., Inc

Condition: Condition - Brest Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This exploratory study aims to develop a novel state assessment indicator for cancer survivors by integrating data from wearable devices (capturing daily activity and physiological rhythms), medication records, and self-reported evaluations of physical and mental condition. The goal is to establish an assessment framework that combines objective and subjective measures, thereby supporting personalized health monitoring and improving the quality of life (QoL) in cancer survivorship. Basic objectives2 - Bio-equivalence

Eligibility: Age-lower limit - 45 years-old = Gender - Female Key inclusion criteria - Inclusion Criteria (all must be met): - Female breast cancer patients who are current members of the Risa-Sana peer support community - Aged between 45 and 55 years at the time of consent - Own a smartphone (iPhone or Android) compatible with Fitbit and Withings apps - Willing to pay a participation fee of 10,000 JPY to cover the cost of Fitbit and a body weight scale Key exclusion criteria - Exclusion Criteria (any of the following): - Scheduled hospitalization during the study period - Currently diagnosed and receiving treatment for a sleep disorder - Unable to pay the participation fee by the deadline - History of skin conditions such as contact dermatitis, or allergies to latex, resin, or metals - Participation in other clinical studies that may interfere with this research during the study period - Judged by the principal investigator to be otherwise unsuitable for participation Target Size - 100

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 04 Month 01 Day Date of IRB - 2023 Year 05 Month 12 Day Anticipated trial start date - 2023 Year 08 Month 01 Day Last follow-up date - 2025 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065917

Disclaimer: Curated by HT Syndication.