APACE - Feasibility of Using Accelerometers to Measure Physical Activity in Cancer Patients on Early Phase Clinical Trials

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention (observational study): This is an observational study

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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. — From baseline for a period of 4-8 weeks
  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 — From baseline for a period of 4-8 weeks
  Successful return of both devices indicates compliance of patients to protocol-defined use of accelerometers.

Trial sites (8)

Other trials for the same condition