Feasibility of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment — WATTOX  

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Gastric Cancer
• Lung Cancer Metastatic
• Lung Cancer, Nonsmall Cell
• Lung Cancer, Small Cell
• Lung Neoplasms
• Oesophageal Cancer
• Pancreatic Cancer
• Small Cell Lung Carcinoma

• NCT number: NCT04440800
• Study type: Observational
• Source: Royal Marsden NHS Foundation Trust
• Contact: Bianca Peet
• Phone: +44 0208 642 6011
• Email: Bianca.Peet@rmh.nhs.uk
• Status: Not yet recruiting
• Start date: July 2020
• Completion date: September 2021