Home And Locally Observed - Tracking (HALO-Trak)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-30

Study Completion Date

2026-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to collect biometric, HRQoL, immune response and genomic data continuously and intermittently during and after chemo or immunotherapy for the generation of a complex dataset using a platform which can aggregate different types of data collected over a time period and, to test the potential for analysis within and across data sets with linkage to clinical outcomes. The framework will have capabilities to integrate data from electronic medical records (EMRs) such as Epic, as well as digital streams including sensor, genomic, imaging and pathology. Such a platform can realise the potential for machine learning (ML) methodologies to address important cancer outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Home Monitoring During Chemoradiation

NCT06597240

Locally Advanced Oesophageal Cancer

RECRUITING

Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester

NCT05099237

Colorectal Cancer Lung Cancer Hematological Cancer +1 more

UNKNOWN NA

Phase I Human Analytics (HALO) Study

NCT05423860

Cardiovascular Diseases Cancer Dementia +1 more

RECRUITING

Telematics Device for Daily Monitoring of Vital Signs in Cancer

NCT05650814

Cancer Cardiovascular Diseases Respiratory Disease

UNKNOWN NA

Wearable Activity Tracking to Curb Hospitalizations

NCT06587100

Hematopoietic Neoplasm Malignant Solid Neoplasm Lymphatic System Neoplasm

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Investigators overarching aim is to determine the relationship between measures of physical performance status including heart rate and steps, health related quality of life (HRQoL) and genomic and immunogenomic phenotype on cancer outcomes in patients receiving chemotherapy or immunotherapy for haematological or metastatic cancer including renal (papillary, and RCC), breast, prostate, and other solid tumours. The primary objective is to test the feasibility of integrating diverse data streams (genomic, HR QoL and biometric) on a novel platform, capable of integrating data streams thus generating complex datasets for analyses using machine learning methodologies.

Secondary objectives will be to conduct exploratory analysis assessing the relationship between individual and combined data types and cancer outcomes.

Analysis using existing and novel computational models will be applied to the data to events in the acute and chronic setting that are common in patients diagnosed with cancer undergoing systemic therapy such as chemotherapy and immunotherapy. The outputs from this study will help inform future studies and trials designed to inform patients about their health status during cancer therapy

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Halo Wearable data device

A wrist-worn tracker with heart-rate monitor and pedometer (step counter), as well as a mobile app.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ● A diagnosis of a metastatic or haematological cancer undergoing systemic therapy

* Undergoing at least 1 planned cycle of chemotherapy or immunotherapy, according to standard of care practices.
* Ability to understand and the willingness to sign a written informed consent.
* Able to ambulate without assistance or walking aid.
* Have an Android or iOS phone and willing to download the Ethera app

Exclusion Criteria

* ● Physical disabilities that preclude daily walking

* Inability to provide informed consent.
* Unable to use and operate the Ethera Health Monitoring Smartphone App. (Apple or Android)
* Medical or psychiatric condition which in the investigator's opinion would affect the successful completion of the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No