Wearable
DeviceContinuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
Other names: Vivosmart Garmin bracelet
NCT Number: NCT06590506
The present study aims to analyze different genetic, phenotypic, environmental, social and lifestyle characteristics of cancer patients who are going to start a first line of cancer treatment with palliative intent and their possible relationship with tumor response or tolerance to treatment. In this way, the aim is to identify a series of variables that allow a better selection of patients and oncological treatments.
Interested in participating?
Request Info18 year and older
Female
Observational
Hospital Universitario A Coruña, A Coruña, A Coruña/ Galicia, Spain
The objective of this study is to obtain a cohort of patients with advanced cancer that is robust and large enough to study the nature and possible interrelation between these variables and their influence on the response and tolerance to treatment.
To do this, the investigators will rely on the first of the high-definition medicine strategies and evaluate the main health determinants of each individual.
This strategy will be use because by obtaining a personal baseline from a sufficiently large cohort of patients the investigators will be able to interrelate and identify those variables that have greater weight when it comes to obtaining a response or good tolerance to oncological treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous monitoring thought data recorded with wearable (Vivosmart Garmin bracelet)
Other names: Vivosmart Garmin bracelet
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
To generate a large and solid cohort of clinical, analytical and epidemiological variables in patients with advanced cancer breast, lung and colon
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
The feasibility of collecting heart rate using activity bracelets (wareables)
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
The feasibility of collecting oxygen saturation using activity bracelets (wareables)
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
The feasibility of collecting physical activity using activity bracelets (wareables).
Average time of physical activity: It is the average time, measured in minutes, that the patient remains active. It is a variable that aims to show how long, on average, the individual is capable of maintaining continuous physical activity.
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
The feasibility of collecting daily sleep using activity bracelets (wareables). It consists of measuring the hours of daily sleep and the duration of each of the sleep phases. Normal sleep consists of two phases that repeat cyclically: the non-REM (NREM) phase, defined as the non-rapid eye movement phase of sleep; and the REM phase or rapid eye movement sleep phase. Monitoring sleep hours and quality by analyzing vital signs during sleep can detect sleep abnormalities and their correlation with the patient's quality of life.
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
Evaluate the porcentage of patient who meet the adherence to wear wearable monitoring. Measure the time that the patient wears the wearable throughout the study 24 hours a day (with the exception of the times necessary to recharge the battery). The included patients must commit to wearing the wearable for the entire time established in the protocol to optimize their quality and the results obtained.
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
Correlation between the Performance Status determined by the clinician and the patient's daily activity level.
The activity tracker will record your step count for each day. The investigators will plot the average daily step count and 95% confidence interval over the entire study period. You will then study the change in step count trajectory during the study. A linear mixed model will be used to describe change over time..
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
Correlation between the quality of life reported by the patient through QLQ questionnaires (EORTC QLQ-C30, Goldberg-GHQ28, Mediterranean diet adherence questionnaire and PRO-CTCAE) and the data collected through wearables
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
Identify changes in patients' physical routine throughout the monitoring period: The activity tracker will record your step count for each day. The investigators will plot the average daily step count and 95% confidence interval over the entire study period. You will then study the change in step count trajectory during the study. A linear mixed model will be used to describe change over time.
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
Correlation between the patient's degree of physical activity and tolerance and response to treatment
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first assessed up to 36 months
Correlation between the patient's physiological adaptation to exercise and tolerance and response to treatment
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
Correlation between tumor stage and tolerance and response to treatment
Time frame: From date of inclusion until the date of death from any cause or the date patient withdrawal, whichever came first, assessed up to 36 months
Correlation between tumor origin and tolerance and response to treatment
Contact information is provided by the study sponsor or research team.
Centro Nacional de Investigaciones Oncologicas CARLOS III
Other
High Definition Medicine: Establishment of a Cohort of Patients With Advanced Cancer for Prospective High-resolution Follow-up
Acronym: HDM-PMP22
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05004116
Advanced Cancer, Metastatic Solid Tumor
New York, United States
View Trial DetailsNCT06440005
Advanced Cancer, Angiosarcoma
Los Angeles, California, United States
View Trial DetailsNCT06548672
Advanced Cancer, Metastatic Solid Tumor
Cleveland, Ohio, United States
View Trial DetailsNCT04419532
Advanced Cancer, Metastatic Solid Tumor
New York, United States
View Trial Details