Big Data for Quality of Life in Head and Neck Cancer — BD4QoL  

Quality of Life Clinical Trial

Official title: A Multicenter Randomized Trial for Quality of Life Evaluation by Non-invasive Intelligent Tools During Post-curative Treatment Follow-up for Head and Neck Cancer

Status Recruiting

Clinical Trial Summary

Depending on disease stage, head and neck cancer (HNC) can be cured either with a single modality or with multimodal treatments, consisting of various combinations of surgery, radiotherapy, and chemotherapy. Despite treatment with curative intent, loco-regional recurrences and/or distant relapses are frequent. Moreover, these therapeutic approaches result in significant acute toxicities and late sequelae. Therefore, quality of life (QoL) is often impaired in these survivors. It is known that QoL is a prognostic factor because it is related to overall survival in cancer patients and to loco-regional control in HNC patients.

The adoption of mobile technologies of common use (i.e. embedded into standard mobile phones) for behavior reconstruction and linkage of behavior modifications to quality of life indicators, and the realization of predictive models for quality of life modifications will allow seamless and unobtrusive data capture over time, making the execution of clinical investigations more precise and less burdensome as compared to standard (manual) data capture.

The main aim of the present study is to reduce and to anticipate, with the use of the non-invasive Big data for quality of life (BD4QoL) platform, the proportion of HNC survivors experiencing a clinically meaningful reduction in QoL.

Clinical Trial Description

The BD4QoL platform consists of a set of services to allow patient monitoring and empowerment, through two main tools: Point of Care application to manage all patients data and follow-up by clinical investigators, and a mobile application (App) installed on participating subject's smartphone. Also, a web-form tool is delivered to allow the QoL questionnaire completion.

To achieve the study objectives, the BD4QoL platform will use the following sensors embedded in a smartphone to collect data which will be used to identify behavioral and affective traits associated with study outcomes. Sensors at mobile phone used to collect relevant data are the following:

• Accelerometer (x,y,z measurements)

• Global Positioning System - GPS (Lat, Long)

• Ambient light (measurement of light in the room / area where the mobile device is located)

• Screen (Status ON or OFF for smartphone device screen)

• Activity (type of activity with which the person engages,which can be one of these:

Still, Walking, Running, On_Bicycle, In_Vehicle)

• Steps (total number of steps per day and per hour)

• Daily connections to wifi networks (naming of wifi connections as well as corresponding duration)

• Data detected from the mobile device's operating system (phone usage logs, phone applications usage) and from external datasets (steps, identification of places (Points of Interest) visited based on participant's permissions, through the correlation of one's GPS signal with external datasets from Foursquare and OpenStreet maps) The above data will be used to detect activities and behaviors which have a high likelihood of being meaningfully related with participants' QoL trajectories.

The BD4QoL App, available for Android, will be able to collect and store data about the following domains: mobility, physical activity, activities of daily living, instrumental activities of daily living, socialization, cognitive function, health related activities as well as affective personal data. A summary of the findings and the supporting data will be available to the patient and clinical investigators , through a dashboard available on mobile devices for patients and through the Point of Care (PoC) web tool for clinical investigators. The data collected by the mobile App will not be available to the technology manufacturer and will be transferred in almost-real-time (real-time when possible, as soon as data transfer is available) to the central BD4QoL repository (as long as there is available storage in the local memory storage of the mobile device).

In the interval between visits, study participants, allocated in the intervention arm, will be able to interact electronically with a chatbot, which will be part of the BD4QoL platform, implementation based on IBM Watson technology. The chatbot is an application to empower patients to manage their QoL and health, under the supervision of clinical investigators. The chatbot will have a series of e-coaching (electronic coaching) functions that include: (i) dialogue management that allows the patient to be counselled by chatting electronically in a structured and effective way; (ii) management of two-way communications with healthcare professionals [e.g. for the patient to request specific support in case of special needs, or for the chatbot to invite the patient for a visit in case of an early detection of health-related QoL (HRQoL) or health issues; identified people will have to be listed on the delegation log by the Principal Investigator (PI)]; (iii) detection of affective traits embodied in the e-coach / patient dialogue, through sentiment analysis and emotion analysis technologies to gather data about the participant mood. The latter element can be used to both re-adapt the chatbot counselling strategy, as well as to provide additional information on subjects mood to clinical investigators. The adverse events that the chatbot will be able to recognise will be the following: fatigue, malaise, fever, excessive sleepiness, difficulty sleeping, depression, change in social circumstances, neck swelling, facial pain, difficulty breathing, nose bleeds, difficulty speaking, dry mouth, tooth loss, muscle weakness, ear pain, difficulty hearing, tinnitus, vertigo, nausea, diarrhea, constipation, difficulty seeing, dry eye, eye pain, nervous eyelid, eye floaters, swollen eye, bleeding eyes, eye watering, sexuality issues, weight loss, difficulty swallowing, mouth sores, appetite loss, difficulty opening mouth, difficulty eating, increased sensitivity to smells, no taste.

The platform will provide the investigators with real time data of device usage (e.g number and type of alerts and chatbot interactions by patients) and it will integrate the electronic case report forms (eCRFs) as a study monitoring dashboard.

The BD4QoL platform used in this trial is not to be considered a medical device and is used for experimental assessment only. No drugs will be suggested by the automated chatbot responses. Tips provided by the chatbot regarding detected symptoms are also not to be considered clinical advice by any means and should not be a substitute for conversations with a member of a trained medical personnel. ;

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Quality of Life
• Survivorship

• NCT number: NCT05315570
• Study type: Interventional
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Lisa Licitra, MD, Prof
• Phone: +39 02 2390 2810
• Email: bd4qol@unimi.it
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Completion date: June 1, 2025