Home And Locally Observed - Tracking (HALO-Trak)

NCT05971277 | Recruiting

• 2 other identifiers: 150745312296
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (5)

• Primary Objective

  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

  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

  This will include blood samples (30mls) and stool samples maximum frequency will be monthly

  one month to 52 weeks

• Clinical Outcome data

  Data will be collected via an electronic case report form-

  one month to 52 weeks

• Quality of life Questionnaire

  EORTC QLQ C30- questionnaire will be collected monthly

  one month to 52 weeks

Interventions

Halo Wearable data device DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ● 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

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

UCL London

London, W1W 7TY, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genomic and microbiome analysis, statistical analysis

Central Study Contacts

John D Kelly, Professor

CONTACT

07549152902; j.d.kelly@ucl.ac.uk

Hazel McBain

CONTACT

07342976009; hazelmcbain@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: August 2, 2023
• Study Start: January 30, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 2, 2023

Record last verified: 2023-01

Locations

GB (1)