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

Last updated: March 5, 2025
Sponsor: University of Manchester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

No intervention (observational study)

Clinical Study ID

NCT06868355
NHS002002
311863
  • Ages > 16
  • All Genders

Study 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

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

Exclusion Criteria:

  • Judgement by the investigator that the individual should not participate if they areunlikely to comply with study procedures and requirements.

  • Patient deemed ineligible for enrolment onto an early phase clinical trial.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: No intervention (observational study)
Phase:
Study Start date:
September 28, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • National Cancer Institute of Milan (INT)

    Milan,
    Italy

    Active - Recruiting

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona,
    Spain

    Active - Recruiting

  • START Madrid CIOCC

    Madrid,
    Spain

    Site Not Available

  • START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital

    Madrid,
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Pamplona,
    Spain

    Active - Recruiting

  • Instituto de Investigación Sanitaria (INCLIVA)

    Valencia,
    Spain

    Active - Recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester,
    United Kingdom

    Completed

  • The Christie NHS Foundation Trust

    Manchester,
    United Kingdom

    Completed

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