Clinical trial NCT06868355: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: The Christie NHS Foundation Trust
name: Institute of Cancer Research, United Kingdom
First posted: 2025-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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 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.

Primary outcomes:
measure: 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.
timeFrame: From baseline for a period of 4-8 weeks
measure: Successful return of both devices
timeFrame: From baseline for a period of 4-8 weeks
Secondary outcomes:
measure: Overall daily patient physical activity across 24 hours measured in millgravity
timeFrame: From baseline for a period of 4-8 weeks
measure: Time spent in inactivity (total and in >30 minute periods over 24 hours)
timeFrame: From baseline for a period of 4-8 weeks
measure: Time spent in accelerometer-defined light intensity activity, moderate activity and vigorous activity throughout the day in minutes
timeFrame: From baseline for a period of 4-8 weeks
measure: Eastern Cooperative Oncology Group Performance Status (ECOG PS) as determined by investigator at each timepoint on the study
timeFrame: From baseline for a period of 4-8 weeks
measure: Patient self-reported physical activity level (captured from questionnaire)
timeFrame: From baseline for a period of 4-8 weeks
measure: The amount of time slept each night in minutes
timeFrame: From baseline for a period of 4-8 weeks
measure: Sleep efficiency determined by calculating the time asleep (minutes) over the time spent in bed
timeFrame: From baseline for a period of 4-8 weeks
measure: The variability in sleep duration over the study period
timeFrame: From baseline for a period of 4-8 weeks
measure: Sleep regularity over the study period
timeFrame: From baseline for a period of 4-8 weeks
measure: Variability of sleep over the study period
timeFrame: From baseline for a period of 4-8 weeks
measure: Documented insomnia grade by Common Terminology Criteria for Adverse Events (CTCAE) criteria
timeFrame: From baseline for a period of 4-8 weeks
measure: Patient reported insomnia score (captured from questionnaire)
timeFrame: From baseline for a period of 4-8 weeks
measure: Patient reported fatigue score (captured from questionnaire)
timeFrame: From baseline for a period of 4-8 weeks
measure: Documented fatigue grade by Common Terminology Criteria for Adverse Events (CTCAE) criteria at each study timepoint
timeFrame: From baseline for a period of 4-8 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: National Cancer Institute of Milan (INT)
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO)
city: Madrid
country: Spain
facility: START Madrid CIOCC
city: Madrid
country: Spain
facility: START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Valencia
country: Spain
facility: Instituto de Investigación Sanitaria (INCLIVA)
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References: