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

August 8, 2025 updated by: Donna Graham, University of Manchester

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • National Cancer Institute of Milan (INT)
        • Contact:
        • Principal Investigator:
          • Matteo Duca
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Vall d'Hebron Institute of Oncology (VHIO)
        • Principal Investigator:
          • Elena Garralda
        • Contact:
      • Madrid, Spain
        • Not yet recruiting
        • START Madrid CIOCC
        • Principal Investigator:
          • Irene Moreno
        • Contact:
      • Madrid, Spain
        • Not yet recruiting
        • START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital
        • Principal Investigator:
          • Victor Moreno
        • Contact:
      • 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:
  • United Kingdom
      • Leicester, United Kingdom
        • Completed
        • University Hospitals of Leicester NHS Trust
      • Manchester, United Kingdom
        • Completed
        • The Christie NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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.
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall daily patient physical activity across 24 hours measured in millgravity
Time Frame: From baseline for a period of 4-8 weeks
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)
Time Frame: From baseline for a period of 4-8 weeks
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
Time Frame: From baseline for a period of 4-8 weeks
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
Time Frame: From baseline for a period of 4-8 weeks
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)
Time Frame: From baseline for a period of 4-8 weeks
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
Time Frame: From baseline for a period of 4-8 weeks
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
Time Frame: From baseline for a period of 4-8 weeks
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
Time Frame: From baseline for a period of 4-8 weeks
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
Time Frame: From baseline for a period of 4-8 weeks
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
Time Frame: From baseline for a period of 4-8 weeks
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
Time Frame: From baseline for a period of 4-8 weeks
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)
Time Frame: From baseline for a period of 4-8 weeks
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)
Time Frame: From baseline for a period of 4-8 weeks
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
Time Frame: From baseline for a period of 4-8 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manchester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute of Cancer Research, United Kingdom
The Christie NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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