Clinical trial NCT04440800: Feasibility of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment
Official title: Remote Monitoring of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer, Small Cell
Pancreatic Cancer
Gastric Cancer
Oesophageal Cancer
Lung Cancer, Nonsmall Cell
Lung Cancer Metastatic
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participant population whose data will be subjected to the study analysis includes registered patients for whom baseline median daily step count was available and who were compliant with wearing the device during the follow up.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \>/= 18.
* Advanced lung (NSCLC or SCLC) cancer or patients with upper gastrointestinal cancer (gastric, oesophageal, pancreatic) starting a new line of systemic anti-cancer therapy.
* Willingness to wear an activity tracker and undergo remote monitoring
* Access to a smart phone.
* Willingness to have a Fitbit App installed on their smartphone
* Willingness to have a pseudo- anonymised FitBit account created for the purposes of the study
* PS 0-2.
* 1 or more previous lines of treatment.

Exclusion Criteria:

* Physical conditions that preclude daily walking
* Inability to give informed consent.
* Medical or psychiatric condition which in the investigators opinion would affect the successful completion of the study.
* Immediate need to start systemic anticancer therapy

Primary outcomes:
measure: Feasibility of monitoring reductions in step count in people with advanced lung cancer or upper gastrointestinal cancers starting systemic anti-cancer therapy.
timeFrame: Analysis 4 months after last patient recruited
measure: Feasibility of undertaking a timely ambulatory review, of participants in whom a reduction of steps is detected
timeFrame: Analysis 4 months after last patient recruited
Secondary outcomes:
measure: Participant compliance with use of activity monitor
timeFrame: Analysis 4 months after last patient recruited
measure: Utility of monitoring steps counts as a trigger for ambulatory assessment for the identification of new or worsening adverse events in people with cancer.
timeFrame: Analysis 4 months after last patient recruited
measure: Sensitivity of monitoring steps counts for the identification of new or worsening adverse events in people with cancer
timeFrame: Analysis 4 months after last patient recruited
measure: Number of hospitalisation episodes.
timeFrame: Analysis 4 months after last patient recruited
measure: Proportion of hospitalisation episodes associated with WAT-triggered ambulatory reviews.
timeFrame: Analysis 4 months after last patient recruited
measure: Acceptability of remote activity tracking
timeFrame: At study completion, approximately 1 year after beginning recruitment
Other outcomes:
measure: Correlation between steps count, physician assessed WHO performance status (PS), quality of life (QoL) and muscle mass/attenuation/function
timeFrame: Analysis 4 months after last patient recruited
measure: Correlation between resting heart rate, hospitalisation and muscle mass/attenuation/function
timeFrame: Analysis 4 months after last patient recruited
Locations:
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust - London and Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Nadia Yousaf
role: PRINCIPAL_INVESTIGATOR
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