CancerAPACENCT06868355
APACE - Feasibility of Using Accelerometers to Measure Physical Activity in Cancer Patients on Early Phase Clinical Trials
An observational study of Cancer, run by University of Manchester at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- How many people
- 40 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 28 Sep 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Subir Singh contact
8 sites in 3 countries
Spain5 sites, 5 recruiting
- Recruiting
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona
Elena Garralda, +34 932 54 34 50, egarralda@vhio.net
Elena Garralda
- Not yet recruiting
START Madrid CIOCC
Madrid
Irene Moreno, (+34) 911 23 99 66, irene.moreno@startmadrid.com
Irene Moreno
- Not yet recruiting
START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital
Madrid
Victor Moreno, (+34) 91 550 48 00, victor.moreno@startmadrid.com
Victor Moreno
- Recruiting
Clínica Universidad de Navarra
Pamplona
Mariano Ponz Sarvisé, +34 948 25 54 00, mponz@unav.es
Mariano Ponz Sarvisé
- Recruiting
Instituto de Investigación Sanitaria (INCLIVA)
Valencia
Andrés Cervantes Ruipérez, +34 626 85 87 57, andres.cervantes@uv.es
Desamparados Roda
United Kingdom2 sites
- Completed
University Hospitals of Leicester NHS Trust
Leicester
- Completed
The Christie NHS Foundation Trust
Manchester
Italy1 site, 1 recruiting
- Recruiting
National Cancer Institute of Milan (INT)
Milan
Matteo Duca, 0223903650, ecdd@istitutotumori.mi.it
Matteo Duca
About this study
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
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.
- Conditions
- Cancer
- Being tested
- No intervention (observational study)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline for a period of 4-8 weeks
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline for a period of 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start28 Sep 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- The Christie NHS Foundation Trust, Institute of Cancer Research, United Kingdom
- Responsible party
- Principal investigator, Donna Graham, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868355
- Sponsor's protocol ID
- NHS002002
- Other IDs
- 311863
- Acronym
- APACE
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06868355
- Acronym / sponsor ID
- APACE / NHS002002
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust, Institute of Cancer Research, United Kingdom
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)This is an observational study | Other | – |
Primary outcome
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.
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.
14 secondary outcomes
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
Patient reported fatigue score (captured from questionnaire)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Subir Singh contact
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Manchester at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gayle Patterson (07919719013, gayle.patterson@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From baseline for a period of 4-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.