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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: No intervention (observational study)

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Gayle Patterson; Phone Number: 07919719013; Email: gayle.patterson@manchester.ac.uk
• Study Contact Backup: Name: Subir Singh; Email: subir.singh@nhs.net

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • National Cancer Institute of Milan (INT)
    • Contact: Matteo Duca; Phone Number: 0223903650; Email: ecdd@istitutotumori.mi.it
    • Principal Investigator: Matteo Duca
• Spain
  • Barcelona, Spain
    • Recruiting
    • Vall d'Hebron Institute of Oncology (VHIO)
    • Principal Investigator: Elena Garralda
    • Contact: Elena Garralda; Phone Number: +34 932 54 34 50; Email: egarralda@vhio.net
  • Madrid, Spain
    • Not yet recruiting
    • START Madrid CIOCC
    • Principal Investigator: Irene Moreno
    • Contact: Irene Moreno; Phone Number: (+34) 911 23 99 66; Email: irene.moreno@startmadrid.com
  • Madrid, Spain
    • Not yet recruiting
    • START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital
    • Principal Investigator: Victor Moreno
    • Contact: Victor Moreno; Phone Number: (+34) 91 550 48 00; Email: victor.moreno@startmadrid.com
  • Pamplona, Spain
    • Recruiting
    • Clínica Universidad de Navarra
    • Contact: Mariano Ponz Sarvisé; Phone Number: +34 948 25 54 00; Email: mponz@unav.es
    • Principal Investigator: Mariano Ponz Sarvisé
  • Valencia, Spain
    • Recruiting
    • Instituto de Investigacion Sanitaria (INCLIVA)
    • Principal Investigator: Desamparados Roda
    • Contact: Andrés Cervantes Ruipérez; Phone Number: +34 626 85 87 57; Email: andres.cervantes@uv.es
• United Kingdom
  • Leicester, United Kingdom
    • Completed
    • University Hospitals of Leicester NHS Trust
  • Manchester, United Kingdom
    • Completed
    • The Christie NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline for a period of 4-8 weeks
Successful return of both devices	Successful return of both devices indicates compliance of patients to protocol-defined use of accelerometers.	From baseline for a period of 4-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline for a period of 4-8 weeks
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.	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	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.	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	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.	From baseline for a period of 4-8 weeks
Patient self-reported physical activity level (captured from questionnaire)	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.	From baseline for a period of 4-8 weeks
The amount of time slept each night in minutes	This data is collected by the accelerometer. This statistic is a continuous variable and its agreement with patient's self-reported insomnia and investigator assessed insomnia will be assessed using Pearson's correlation coefficient and one-way ANOVA.	From baseline for a period of 4-8 weeks
Sleep efficiency determined by calculating the time asleep (minutes) over the time spent in bed	This data is collected by the accelerometer. This statistic is a continuous variable and its agreement with patient's self-reported insomnia and investigator assessed insomnia will be assessed using Pearson's correlation coefficient and one-way ANOVA.	From baseline for a period of 4-8 weeks
The variability in sleep duration over the study period	This data is collected by the accelerometer. This statistic is a continuous variable and its agreement with patient's self-reported insomnia and investigator assessed insomnia will be assessed using Pearson's correlation coefficient and one-way ANOVA.	From baseline for a period of 4-8 weeks
Sleep regularity over the study period	This data is collected by the accelerometer. Sleep regularity over the study period is defined as the percentage probability of an individual being in the same state (asleep vs. awake) at any two time-points 24 hours apart. For example, if it is someone who works varying shift patterns sleep regularity would be low, e.g. they may be sleeping at midnight one day, but awake and working at that time the next day. Someone who goes to sleep and gets up at the same time each day would have high sleep regularity (closer to 100%).	From baseline for a period of 4-8 weeks
Variability of sleep over the study period	This data is collected by the accelerometer. Variability of sleep over the study period is defined as follows: the sleep midpoint is the mid-point between sleep onset and waking. For each participant, we present the mean of this across all valid nights and the variability (standard deviation) across all valid nights. The standard deviation across all valid nights is the variability in sleep mid-point in minutes.	From baseline for a period of 4-8 weeks
Documented insomnia grade by Common Terminology Criteria for Adverse Events (CTCAE) criteria	Investigator assessed insomnia grade by Common Terminology Criteria for Adverse Events (CTCAE) criteria and self-reported insomnia score (captured from questionnaire) are categorical statistics. Their agreement will be assessed using Fisher's exact test.	From baseline for a period of 4-8 weeks
Patient reported insomnia score (captured from questionnaire)	Investigator assessed insomnia grade by Common Terminology Criteria for Adverse Events (CTCAE) criteria and self-reported insomnia score (captured from questionnaire) are categorical statistics. Their agreement will be assessed using Fisher's exact test.	From baseline for a period of 4-8 weeks
Patient reported fatigue score (captured from questionnaire)	Investigator assessed fatigue grade by Common Terminology Criteria for Adverse Events (CTCAE) criteria and self-reported fatigue score (captured from questionnaire) are categorical statistics. Their agreement will be assessed using Fisher's exact test.	From baseline for a period of 4-8 weeks
Documented fatigue grade by Common Terminology Criteria for Adverse Events (CTCAE) criteria at each study timepoint	Investigator assessed fatigue grade by Common Terminology Criteria for Adverse Events (CTCAE) criteria and self-reported fatigue score (captured from questionnaire) are categorical statistics. Their agreement will be assessed using Fisher's exact test.	From baseline for a period of 4-8 weeks

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: Institute of Cancer Research, United Kingdom; The Christie NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NHS002002; 311863 (Other Identifier: IRAS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No