Pancreatic Cancer Clinical Trial
— WATTOXOfficial title:
Remote Monitoring of Wearable Activity Trackers for Detection of TOXicity in People Receiving Systemic Anticancer Treatment: a Feasibility Study
NCT number | NCT04440800 |
Other study ID # | CCR5083 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2020 |
Est. completion date | September 2021 |
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Marsden NHS Foundation Trust - London and Surrey | London |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Correlation between steps count, physician assessed WHO performance status (PS), quality of life (QoL) and muscle mass/attenuation/function | To explore the correlation between /median step-count and: physician assessed PS as recorded at treatment visits or CT SMA, SMI and MRA HGS TUaG QoL (as assessed by FACT-G and EORTC-q30C). Nutrition (as assessed by BMI and PG-SGA) |
Analysis 4 months after last patient recruited | |
Other | Correlation between resting heart rate, hospitalisation and muscle mass/attenuation/function | To explore the correlation between changes in resting heart rate from baseline and mean/median steps, hospitalisation, HGS, SMA, SMI and MRA | Analysis 4 months after last patient recruited | |
Primary | Feasibility of monitoring reductions in step count in people with advanced lung cancer or upper gastrointestinal cancers starting systemic anti-cancer therapy. | Feasibility of step count monitoring will be determined by measuring the proportion of participants for whom step count was successfully monitored (step count checked for at least 4 out 5 weekdays) for at least 80% of the treatment weeks during the study period. Successful monitoring is defined as a member of the study team logging in to the Fitabase system to review the step count. If 80% of participants are monitored for 80% of the observational time (from the start until the end of treatment - either at completion or if treatment is stopped), this will be considered feasible. |
Analysis 4 months after last patient recruited | |
Primary | Feasibility of undertaking a timely ambulatory review, of participants in whom a reduction of steps is detected | Feasibility of a timely ambulatory review will be determined by measuring the proportion of participants who are invited for an ambulatory review and attend within 24 hours. If 70% of participants invited for a review attend, this will be considered feasible. | Analysis 4 months after last patient recruited | |
Secondary | Participant compliance with use of activity monitor | Percentage compliance with wearable activity trackers (WAT) will be defined as wearing the device for at least 70% of waking hours. It is assumed for the purposes of this study that participants are awake between 0700hrs to 2200hrs. Compliance can be assumed if the device is able to measure heart rate during these hours, which can be assessed from the daily heart rate graph. | Analysis 4 months after last patient recruited | |
Secondary | Utility of monitoring steps counts as a trigger for ambulatory assessment for the identification of new or worsening adverse events in people with cancer. | The utility of monitoring steps counts for the identification of new or worsening adverse events in people with cancer will be assessed by recording the number of clinical reviews triggered by step count. | Analysis 4 months after last patient recruited | |
Secondary | Sensitivity of monitoring steps counts for the identification of new or worsening adverse events in people with cancer | The sensitivity of monitoring steps counts for the identification of new or worsening adverse events in people with cancer will be assessed by recording how many of the triggered ambulatory assessments were deemed clinically appropriated by the assessing clinician. | Analysis 4 months after last patient recruited | |
Secondary | Number of hospitalisation episodes. | The total number of hospitalisation episodes will be recorded, including all WAT-triggered ambulatory reviews and those that occur outside of the study visits | Analysis 4 months after last patient recruited | |
Secondary | Proportion of hospitalisation episodes associated with WAT-triggered ambulatory reviews. | The proportion of hospitalisation episodes that were WAT-triggered clinical reviews, including those with no detected abnormality, will be compared to the number of episodes that were not associated with a WAT-triggered review. | Analysis 4 months after last patient recruited | |
Secondary | Acceptability of remote activity tracking | Acceptability of remote activity tracking will be determined by assessing the qualitative patient experience of undergoing remote monitoring as determined by focus group interview | At study completion, approximately 1 year after beginning recruitment |
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