Training Data Collection & AI Development

NCT05378854 | Completed

• 1 other identifier: 875329
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to facilitate collection of real-world data to test and train the analytics engine for each prototype algorithm. Preliminary datasets will be generated to enable a dry run of the prototype algorithms to check their predictive functionality as part of simulated 'experimental' scenarios at each LifeChamps partner site. This preparatory work will be critical to the development of the LifeChamps platform, prior to progressing to a larger scale feasibility trial.

Conditions

Breast Cancer; Prostate Cancer

Keywords

Cancer; mHealth App; Ambient Sensors; Wearables; Smartwatch; Smart scale; Analytics Engine

Outcome Measures

Primary Outcomes (1)

• Analytical models

  The collected data will be used to train and test the analytical models. For example, the initial data from sensors will be refined, further, with statistical, spectral and supervised learning analyses to identify and extract possible patterns (e.g., activities of daily living) inside their signals. Sensor, EHR and PROM data will be all analysed together through exploratory algorithms (e.g., pairwise Markov random fields, Bayesian networks) to identify possible interactions and dependencies among their trajectories, mapping the frailty and QOL domains of elderly prostate and breast cancer patients across all the data collection process.

  6 months

Secondary Outcomes (9)

• Anxiety and Depression

  3 months

• Symptoms

  3 months

• Medication Adherence

  3 months

• Frailty

  3 months

• Quality of Life assessment

  3 months

Other Outcomes (3)

• Recruitment rate

  3 months

• Participant retention

  3 months

• Technology Adherence

  3 months

Study Arms (1)

LifeChamps Platform

EXPERIMENTAL

Participants will be asked to use the LifeChamps platform and will be provided with the study equipment.

Other: LifeChamps Platform

Interventions

LifeChamps Platform OTHER

Participants will be provided with the study equipment, i.e., a mobile app, smartwatch, smart scale, location home sensor, a smart plug, and a micro-computer, with which they will need to interact with the devices for three months. Specifically, participants should wear the activity tracker wristband (Fitbit Charge 4) as much as possible. Additionally, participants should use the smart scale to weigh themselves and the mobile app to fill in selected PROMs monthly, while the ambient home sensors (location home senor (LOCS) and smart plug) will be passively collecting information about their everyday living during these three months. Lastly, participants' clinical and demographic data from the local EHRs will be collected.

LifeChamps Platform

Eligibility Criteria

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

You may qualify if:

• Breast or prostate cancer.
• Diagnosed with early stage (I-III) cancer (breast, prostate) and living beyond initial cancer treatment (curative/incurable).
• Diagnosed with advanced or metastatic disease with life expectancy \>12 months.
• At least 1 month after a) local treatment with curative intent (surgery, radiotherapy) or b) initiation of systemic treatment (hormone treatment, CDK4/6 or new generation antiandrogens).
• Absence of diagnosed secondary malignancy.
• Deemed by a member of the multidisciplinary team as physically and psychologically fit to participate in the study.
• Able to read, write and understand the respective local language (greek).
• Achieve a score of above 2 on the Mini-Cog during the screening process.
• Able to bring and use own Android version 10 (or above) device during the study.
• Domestic 24/7 internet access via wi-fi and/or 4G mobile data (will be provided if unavailable).

You may not qualify if:

• Currently receiving chemotherapy.
• Terminal cancer stage on palliative care.
• Survival prognosis of \<18 months from the time of recruitment.
• Unwilling to provide written informed consent.
• Presence of internal medical device (e.g. pacemaker etc.)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Region Stockholm: collaborator

Study Sites (1)

Laboratory of Medical Physics and Digital Innovation, AUTH

Thessaloniki, 54636, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Panos D Bamidis, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single Group: Clinical trials with a single arm A prospective, time-series design will be employed, whereby the LifeChamps platform will be deployed for a total of 3 months.

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 18, 2022
• Study Start: July 31, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available 5 years after the end of the study for indefinite period of time.
• Access Criteria: Data will be made available only for non-commercial research purposes.

Locations

GR (1)