Increased physical activity has been shown to improve outcomes for cancer patients, however the measure of activity is highly variable and understudied in cancer patients on early phase clinical trials where activity is used as a criteria for eligibility. Additionally, more than half of cancer patients experience fatigue at some point in their treatment with exercise and psychosocial interventions currently recommended as interventions. Therefore, it is important to be able to more accurately measure activity and fatigue in cancer patients to ensure adequate intervention, management and appropriate access to treatment.
This proposal is a non-interventional feasibility study designed to collect activity and sleep data from patients with advanced cancer newly enrolled in early phase clinical trials. The data will be collected over a 5-6 week period using a wearable accelerometer device. This study will be conducted concurrently with the early phase trial related activities/treatment and will have no impact on a patient's clinical pathway. Data generated from the study will be used to evaluate the feasibility of collecting activity and sleep data from patients with advanced cancer on early phase clinical trials.
In this study, participants in the UK will be able to opt-in to using eNutri, a web-based graphical food frequency questionnaire (FFQ), and provide feedback on its usability. The output of eNUTRI will help us understand if there is a use for eNutri in cancer care environments for a range of purposes such as providing nutritional support for cancer patients, and exploring drug-nutrient interactions on the patient outcome.
Voluntary informed consent.
Aged at least 16 years.
Consented to an early phase clinical trial.
Willingness to wear a device for the duration of the study.
Judgement by the investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements.
Patient deemed ineligible for enrolment onto an early phase clinical trial.
Participants will be identified by the research team for the Phase 1 study they are enrolling on; the Phase 1 study team are the participant's direct care team.
Cohort
Prospective
No intervention (observational study)
Other interventionThis is an observational study
Minimum of 3 valid days of data per week or per study period. A valid day is defined as 16 hours of data across one day.
This data is collected by the accelerometer. A minimum of 3 valid days of data per week or study period indicates compliance of patients to protocol-defined use of accelerometers.
Successful return of both devices
Successful return of both devices indicates compliance of patients to protocol-defined use of accelerometers.
Overall daily patient physical activity across 24 hours measured in millgravity
Accelerometer-collected activities will be summarised into the following statistic: Overall daily patient physical activity across 24 hour measured in milligravity. This statistic is a continuous variable and its agreement with patient-reported physical activity and investigator-assessed Eastern Cooperative Oncology Group Performance Status (ECOG PS) will be assessed using Pearson's correlation coefficient and one-way ANOVA.
Time spent in inactivity (total and in >30 minute periods over 24 hours)
This data is collected by the accelerometer. It is a continuous variable and its agreement with patient-reported physical activity and investigator assessed Eastern Cooperative Oncology Group Performance Status (ECOG PS) will be assessed using Pearson's correlation coefficient and one-way ANOVA.
Time spent in accelerometer-defined light intensity activity, moderate activity and vigorous activity throughout the day in minutes
This data is collected by the accelerometer. This statistic is a continuous variable and its agreement with patient-reported physical activity and investigator-assessed Eastern Cooperative Oncology Group Performance Status (ECOG PS) will be assessed using Pearson's correlation coefficient and one-way ANOVA.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) as determined by investigator at each timepoint on the study
Patient-reported physical activity (captured from questionnaire) and investigator-assessed Eastern Cooperative Oncology Group Performance Status (ECOG PS) are categorical statistics. Their agreement will be assessed using Fisher's exact test.
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University of Manchester
Lead sponsor
The Christie NHS Foundation Trust
Collaborator
Institute of Cancer Research, United Kingdom
Collaborator
