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

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

Overview

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.

Interventions

• Other No intervention (observational study)
  This is an observational study

Primary outcome measures

• 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. [Time frame: From baseline for a period of 4-8 weeks]
• Successful return of both devices [Time frame: From baseline for a period of 4-8 weeks]

Secondary outcome measures (12)

• Overall daily patient physical activity across 24 hours measured in millgravity [Time frame: From baseline for a period of 4-8 weeks]
• Time spent in inactivity (total and in >30 minute periods over 24 hours) [Time frame: From baseline for a period of 4-8 weeks]
• Time spent in accelerometer-defined light intensity activity, moderate activity and vigorous activity throughout the day in minutes [Time frame: From baseline for a period of 4-8 weeks]
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) as determined by investigator at each timepoint on the study [Time frame: From baseline for a period of 4-8 weeks]
• Patient self-reported physical activity level (captured from questionnaire) [Time frame: From baseline for a period of 4-8 weeks]
• The amount of time slept each night in minutes [Time frame: From baseline for a period of 4-8 weeks]
• Sleep efficiency determined by calculating the time asleep (minutes) over the time spent in bed [Time frame: From baseline for a period of 4-8 weeks]
• The variability in sleep duration over the study period [Time frame: From baseline for a period of 4-8 weeks]
• Sleep regularity over the study period [Time frame: From baseline for a period of 4-8 weeks]
• Variability of sleep over the study period [Time frame: From baseline for a period of 4-8 weeks]
• Documented insomnia grade by Common Terminology Criteria for Adverse Events (CTCAE) criteria [Time frame: From baseline for a period of 4-8 weeks]
• Patient reported insomnia score (captured from questionnaire) [Time frame: From baseline for a period of 4-8 weeks]

Eligibility criteria

Inclusion criteria

• 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.
• Willingness to comply with scheduled study procedures.
• ECOG PS 0 or 1.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 5 centers

• Vall d'Hebron Institute of Oncology (VHIO) — Barcelona
• START Madrid CIOCC — Madrid
• START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital — Madrid
• Clínica Universidad de Navarra — Pamplona
• Instituto de Investigación Sanitaria (INCLIVA) — Valencia

United Kingdom · 2 centers

• University Hospitals of Leicester NHS Trust — Leicester
• The Christie NHS Foundation Trust — Manchester

Italy · 1 center

• National Cancer Institute of Milan (INT) — Milan

Identifiers

NCT: NCT06868355 · NHS002002 · 311863

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗