Home And Locally Observed - Tracking (HALO-Trak) (HALO-Trak)

July 24, 2023 updated by: University College, London

Proof of Concept (POC) Prospective Observational Study to Test a Framework for Integration of Data Streams, Including Molecular Genomic Markers and Wearable Device Data in Patients Receiving Chemotherapy for Advanced Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective
Time Frame: one month to 52 weeks
To measure feasibility of data collection longitudinally in a patient cohort undergoing systemic therapy for metastatic or haematological cancer.
one month to 52 weeks
Remote monitoring data
Time Frame: one month to 52 weeks
To collect activity (steps) and heart rate data. This will be collected using the Ethera Wellness app which participants will download onto their smartphone devices.
one month to 52 weeks
Biological sample data. This will include blood samples (30mls) maximum frequency will be monthly
Time Frame: one month to 52 weeks
This will include blood samples (30mls) and stool samples maximum frequency will be monthly
one month to 52 weeks
Clinical Outcome data
Time Frame: one month to 52 weeks
Data will be collected via an electronic case report form-
one month to 52 weeks
Quality of life Questionnaire
Time Frame: one month to 52 weeks
EORTC QLQ C30- questionnaire will be collected monthly
one month to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150745
  • 312296 (Other Identifier: IRAS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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