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Trial Title:
Home And Locally Observed - Tracking (HALO-Trak)
NCT ID:
NCT05971277
Condition:
Advanced Cancer
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Halo Wearable data device
Description:
A wrist-worn tracker with heart-rate monitor and pedometer (step counter), as well as a
mobile app.
Summary:
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.
Detailed description:
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
Criteria for eligibility:
Study pop:
All patients will be receiving standard of care therapies and will be recruited from
Oncology clinics once a diagnosis of metastatic or haematological cancers has been
established and patients meet all the inclusion criteria
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCL London
Address:
City:
London
Zip:
W1W 7TY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
John D Kelly, Professor
Phone:
075497152902
Email:
j.d.kelly@ucl.ac.uk
Contact backup:
Last name:
Hazel McBain, Snr Nurse
Phone:
07342976009
Email:
hazelmcbain@nhs.net
Start date:
January 30, 2023
Completion date:
April 1, 2026
Lead sponsor:
Agency:
University College, London
Agency class:
Other
Source:
University College, London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05971277
