Pancreatic Cancer Clinical Trial
Official title:
Remote Monitoring of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment: a Feasibility Study
Accurate evaluation of activity status is an important part of the assessment of people with
cancer. Clinician assessments currently used are valuable but have limitations; in
particular, assessment only occurs when the patient attends clinic and is often subjective.
Activity trackers, such as FitBits, give the opportunity to objectively assess activity
status continuously, independent of clinic visits. Previous studies have shown that a
reduction in 1000 steps while receiving cancer treatment is associated with an increased risk
of hospitalisation but it is not known if using information from activity trackers to allow
early intervention is feasible or if it can reduce admission to hospital and improve
outcomes.
The investigators propose a prospective feasibility study in people with advanced lung cancer
or upper gastrointestinal cancers who are starting a new line of systemic anti-cancer
therapy.
Participants will receive a FitBit, which is a commercially available wearable activity
tracker for the duration of their treatment or 4 months (whichever is shorter). Step counts
will be monitored and a reduction in daily steps of >1000 from baseline will trigger contact
by the study team and an ambulatory review. Participants will not receive treatment within
the context of the study.
A recent metanalysis reports that over 40% of people with cancer being treated with
palliative intent have at least 1 unplanned hospital admission during treatment. Furthermore,
up to 83% of people undergoing cancer treatment are likely to attend the Emergency
Departments (ED). The 2019 NHS long-term plan has an emphasis on the use of digital
technologies, remote monitoring to support patients, and acute ambulatory care as an
alternative to ED attendance.
In observational studies of people with cancer, reductions in steps counts correlate with
increased symptoms and risk of hospitalisation.
Therefore, the main aim of this study is to determine whether monitoring of activity and
subsequent ambulatory review triggered by detecting a reduction in steps is feasible in a
timely fashion within an NHS oncology centre.
People with advanced lung cancer (NSCLC, SCLC) or upper gastrointestinal cancers (gastric,
oesophageal or pancreatic) starting a new line of systemic anti-cancer treatment (SACT) will
be recruited at The Royal Marsden Hospital (Chelsea and Sutton sites). Eligible patients will
be approached by clinical teams in the lung and gastrointestinal cancer outpatient clinics.
Participants who are due to start a new line of SACT will be asked to wear a FitBit activity
tracker (resembling a watch). Baseline median daily steps count will be calculated prior
starting SACT for those patients who wear the device for ideally 7 consecutive days, which
must include both weekend and week days.
The device can measure step counts and heart rate. The FitBit will be monitored remotely by
the study team once a day (week days only) using a web-based platform called Fitabase and
will document cases where the step count reduction is >1000 from baseline. Step count and
average heart rate data will be downloaded at the beginning of each treatment cycle and a
summary reported in the MACRO database. Fitabase is a cloud-based data management platform,
which is able to access data which has been synchronised from individual FitBits. Data can be
collected anonymously by associating the device data with a study identification number.
Fitabase does not collect personally identifiable data. No global positioning system (GPS)
data or other data is collected. Passwords are encrypted.
For this feasibility study, activity tracking will take place on working week days only.
A reduction in >1000 steps from the baseline median step count will trigger a telephone call
by a member of the study team. If the fall in steps was not due to non-compliance/malfunction
of the device, the participant will be invited to attend the Clinical Assessment Unit for an
ambulatory review. Participants' acceptance of advice to attend for a review will be
documented. The diagnosis (and clinical necessity as assessed by a clinician), need for
hospitalisation or not, and length of stay will be collected. Further investigations or
management will be determined by clinical need following assessment by a member of the study
team.
If no abnormality is noted the trigger for subsequent phone calls will be adjusted by 500
steps for that patient ie >1500 steps. If no abnormality is found after a second review,
further reviews will only take place after a phone call if there is clinical concern.
Participants will be informed at the beginning of the study to use usual processes if they
feel unwell at any time eg calling the Royal Marsden Macmillan Hotline (RMMH).
Participants will be reviewed at the start of each new cycle of treatment (+/- 7 days) by a
member of the study team to find out if they have been hospitalised and for how long.
Physician-assessed PS, C reactive protein (CRP), albumin, handgrip strength (HGS), Timed Up
and Go (TUaG) will be measured at the first study visit, and skeletal muscle area (SMA),
skeletal muscle index (SMI) and muscle radiation attenuation (MRA) will be measured from the
standard of care baseline CT scan. In addition the investigators will also collect height and
weight demographics, and perform questionnaire-based nutritional (PG-SGA) and quality of life
(QoL) (FACT-G, EORTC-q30C) assessments.
To assess changes in muscle quality and function, HGS, PS, and TUaG will be measured +/- 14
days from each standard of care CT scan. The participant will also undertake QoL and
nutrition questionnaires as per baseline investigation. Weight will be recorded. The CT scan
will be used to calculate SMA, SMI and MRA.
At the end of the study, 5-8 participants will be invited for a focus group to understand
their acceptance and experience of remote activity monitoring while undertaking cancer
treatment.
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