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APACE - Feasibility of Using Accelerometers to Measure Physical Activity in Cancer Patients on Early Phase Clinical Trials
Sponsor: University of Manchester
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.
Official title: APACE - Feasibility of Using Accelerometers to Measure Physical Activity in Cancer Patients on Early Phase Clinical Trials. A Feasibility Study Evaluating the Use of Accelerometers to Capture Physical Activity Levels in Cancer Patients on Early Phase Clinical Trials
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2023-09-28
Completion Date
2025-09-30
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
No intervention (observational study)
This is an observational study
Locations (8)
National Cancer Institute of Milan (INT)
Milan, Italy
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain
START Madrid CIOCC
Madrid, Spain
START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Instituto de Investigación Sanitaria (INCLIVA)
Valencia, Spain
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom