The objective of this study is to:1) explore the feasibility (recruitment, adherence, and absence of major technical problems) of using both medical-grade and consumer grade wearables for continuous measurement of physical activity, posture, balance…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints relate to feasibility of study conduct and data
collection, as well as to feasibility of a future full-scale study.
1) Recruitment rate: number of included patients relative to the number of
invited patients: recruitment rate will be calculated by the percentage of
included patients compared to the total number of eligible patients contacted.
An overall recruitment rate of 60% at the end of the study will be considered
sufficient feasibility.
2) Patient adherence to wear-time Fitbit and Corsano at the designated time
periods: Patients will be asked to wear the Corsano and Fitbit 24 hours per day
for 12 weeks. Adherence to the designated wear-time will be calculated through
the number of hours data gathered compared to the expected amount of data per
individual patient in percentages. The average percentage of this parameter
provides an overall measure of adherence of the wear-time. We do not set an
a-priori feasibility criterion in terms of % adherence, since one of the goals
of the preliminary data analysis is to establish how much data is needed to
generate potentially useful prediction models. This also applies to endpoints 3
and 4.
3) Technical feasibility of continuous measurements: percentage data loss and
gap durations: Data loss may occur due to problems of uploading to the phone or
measurement problems. We will compare gathered data in bytes with the expected
amount of data corrected for loss data due wear-time and express this number
for the individual patient in percentages.
Since the amount of acceptable data-loss is dependent, in part, on the
possibility to deal with such missing data in the analysis, we do not set an a
priori criterion for this outcome. However, extended data loss due to technical
malfunction (i.e., Corsano or fitbit not transmitting data for an interval >4
hours, battery failure) should not happen more than once per patient during
phase 1.
Gap duration will be calculated in time of the interval between continuous
measurement points. The duration will be categorized in durations less than 15
minutes, less than 1 hour, or 4 hours or longer.
4) Patient retainment: number of patients finishing the study: Patient
retainment will be calculated as 1) the number of patients retained in the
study for the full 12 weeks as a percentage of the number of patients who
started the study 2) the number of patients retained in the study until they
have experienced an event, as a percentage of the number of patients who
started the study.
5) PRO-CTCAE adherence rate: Compliance with weekly digital PROMS
questionnaire is calculated by the number of completed questions on Castor. The
average value of this parameter provides an overall measure of compliance with
online symptom monitoring over a period of 12 weeks. Feasibility is accepted
when no individual patients fall below 70% adherence while still in the study.
Secondary outcome
1) Patient acceptance and experience. After the treatment period, subsequently
included participants will be interviewed about their experiences with the use
of Corsano and the Fitbit, and about their views about being continuously
monitored during treatment. A short, structured interview guide will be
prepared. The interview will be audio recorded. Recordings will be transcribed
verbatim and qualitative analysis methods (i.e., coding and aggregating) will
be applied to analyse the data using appropriate software for qualitative data
analysis. Data collection will end once data saturation has been achieved
(i.e., when no new viewpoints emerge), while keeping an eye on gender and
diagnosis balance.
2) Usability Acceptability/satisfaction. Usability of both devices is assessed
by the system usability scale (SUS) which is comprised of 10 statements, rated
on a 5-point Likert scale, regarding the usability of an electronic device or
platform. Based on previously published studies, a mean SUS score of 68 is
chosen as cut point to determine the usability of the system.
3) Treatment-toxicity outcomes: number and grade according to CTCAE of all
treatment related toxicity, number and nature of adverse events such as
unplanned hospitalisation, unplanned adaptation of treatment plan, visits to
the ER, and admission to the ICU, including dates of occurrence. The PRO-CTCAE
is a patient reported outcome (PRO) measurement system developed to evaluate
symptomatic toxicity in patients on cancer clinical trials. It was designed to
be used as a companion tot the Common Terminology Criteria for Adverse Events
(CTCAE), the standard lexicon for adverse event reporting in cancer clinical
trials. The questionnaire items evaluate the symptom attributes of frequency,
severity, interference, amount and presence/absence. Each symptomatic adverse
event is assessed by 1-3 attributes. PRO-CTCAE responses are scored from 0 to 4
(or 0/1 for absent/present). Specific items will be selected that apply to the
three patient groups.
4) Health related quality of life outcomes: EORTC QLQ-C30 is a cancer
specific, self-administered structured questionnaire designed for use in
clinical trials. It contains 30 questions 24 of which are aggregated into 9
multi-item scales: 5 functioning scales (physical, role, cognitive [CF],
emotional, and social); 3 symptom scales (fatigue, pain, and nausea and/or
vomiting); and 1 global health-status scale. The remaining six single items
assess symptoms of dyspnea, appetite loss (AP), sleep disturbance,
constipation, diarrhea, and financial impact. Each of the multi-item scales
includes a different set of items - no item occurs in more than one scale. All
of the scales and single-item measures range in score from 0 to 100. A high
scale score represents a higher response level. A high score for a functional
scale represents a high / healthy level of functioning, a high score for the
global health status / QoL represents a high QoL, but a high score for a
symptom scale / item represents a high level of symptomatology / problems.
5) Appropriateness of chosen time windows of monitoring using the wearables.
This endpoint will be measured at the end of the study comparing the toxicity
rate determined by the clinical specialist, compared to the toxicity determined
by the Kaiku-app .
6) Any action taken by the treating physician or nurse specialist in response
to toxicity.
Background summary
People treated for cancer are often exposed to highly toxic treatments.
Treatment-induced toxicities can be dose-limiting, and can even be
life-threatening. They can also lead to adverse events, including, for example,
hospital admissions or emergency room visits.
Currently, the assessment of toxicity and functioning of patients is based on
physician or nurse judgement, rather than on objective measurements, and is not
performed in real time but during consultations. Recently it has been shown
that routine monitoring of symptoms by self-report toxicity grading via a
mobile app (and subsequent action) decreased adverse events, decreased the
number of emergency room admissions, improved quality of life, and possibly
even impacted positively on survival in patients with cancer. However, these
patient-reported measures still reflect manifest toxicity, whereas the
identification of subclinical signs of toxicity might be even more beneficial.
The current developments in wearable sensor technology enable continuous and
extensive measurement of physiological functions and physical functioning. The
rich data collected via wearables could provide valuable input for clinical
prediction models for toxicity-related adverse events.
However, aside from challenges with data analysis, there are challenges related
to feasibility and patient acceptance of data collection via wearables. These
challenges may differ over different clinical populations, dependent not only
on the type of treatment and toxicity involved, but also on health literacy,
technological readiness, age and socio-economic status. Before a larger study
can be undertaken the feasibility of collecting high quality data using
wearables must be established as well as patient experiences and acceptance.
Study objective
The objective of this study is to:
1) explore the feasibility (recruitment, adherence, and absence of major
technical problems) of using both medical-grade and consumer grade wearables
for continuous measurement of physical activity, posture, balance disturbances,
and physiological parameters (heart rate, respiratory rate, skin temperature,
and electrocardiogram), alongside web/app based PROMS for treatment specific
toxicity during systemic cancer treatment with chemoradiation or immune therapy
in three distinct clinical populations.
2) to explore patients experiences with and views about the use of wearable
data and to correlate the collected wearable data to treatment toxicity
outcomes and apply preliminary machine learning models
Study design
Prospective obsevational:
We will carry out a prospective study with patients receiving chemoradiation
therapy for advanced head and neck cancer, immune therapy or targeted therapy
for advanced melanoma who start treatment, and patients treated with
chemo-radiation or chemo-immuno therapy for non-small cell lung cancer (NSCLC)
at the Antoni van Leeuwenhoek or University Medical Centre of Utrecht. The
study will be performed in two phases. First, we will enroll 10 patients for
each diagnosis group. During this phase the main focus will be on early
feasibility outcomes (recruitment, adherence, and absence of major technical
problems, see 6.1 in C.1) (phase 1 ).
If these feasibility endpoints are met, we will upscale the study to include a
total of 100 consecutive consenting patients (phase 2), to allow for
collection of sufficient data for preliminary analysis of relationships of the
sensor data with clinical outcomes.
In both phases, we will collect physiological and physical activity data using
both medical-grade (Corsano) and consumer-grade (Fitbit) wearables. Each
participant will wear both types of sensors, to enable direct comparisons. In
addition, we will collect self-reported toxicity using a web-based survey
(Castor). This data collection is based on patient reported translations of the
common toxicity criteria for adverse events (PRO-CTCAE). We will also collect
toxicity gradings as recorded in the medical files.
Study burden and risks
The risks associated with this study are negligible.
Missing data: Biosensor data could be missed due to patients forgetting/not
being able to connect the Corsano bracelet to their phone. The software on the
biosensor smartphone will send a notification to the main server when this
happens. The researcher will check the data collection daily on the main server
and contact the patients when data input is being missed. This daily checking
of data input and contacting patients will also be done for the data collection
of the Fitbit and Kaiku-app/Castor websurvey. Due to the remote nature of the
wearables and applications, missing data can be easily spotted and addressed.
Privacy and data storage: The collected data by the wearables will be
temporarily stored on the Google cloud Firebase on EU based servers. These are
highly secured and conform to GDPR. We will make this explicit in the patient
information.
Plesmanlaan 121
amsterdam 1066CX
NL
Plesmanlaan 121
amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
- Patients with advanced head and neck cancer starting concurrent
cisplatin-based chemo-radiation therapy or bioradiationtherapy
- Patients with stage III or stage IV melanoma who start with either
immunotherapy (pembrolizumab, cemplimab, nivolumab (flatdose), ipilimumab -
nivolumab). Or targeted therapy (dabrafenib-trametinib,
encorafenib-binimetinib)
- Patients with locally advanced NSCLC stage III or NSCLC stage IV treated with
low dose cisplatin and radiation therapy or treated with platinum-doublet
chemotherapy with checkpoint inhibition.
- Sufficient mastery of the Dutch language
- Ambulatory without the use of walking aids
- Have an understanding, ability and willingness to fully comply with study
procedures and restrictions
- > 18 years
- Ability to consent
Exclusion criteria
- Known history of heart-rhythm disorder
- Incapability of using digital devices
- Allergic to surgical steel or elastomer / rubber
- Permanent or temporary changes to the skin at locations where the sensors
should be worn, (I.e., scar tissue) that might impact sensor performance
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79232.031.21 |