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NCT06868355Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 14 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
40 (estimated)
First submitted
25 Feb 2025
Start date
28 Sept 2023
Primary completion date
30 Sept 2025
Lead sponsor
University of Manchester
NCT number
NCT06868355

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From 28 Sept 2023 to the primary completion date, 30 Sept 2025
  • 8 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vall d'Hebron Institute of Oncology (VHIO)
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
START Madrid - CIOCC
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainRecruiting
Instituto de Investigacion Sanitaria, INCLIVA
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
University Hospitals of Leicester NHS Trust
Coordinator of this site? Confirm its status
LeicesterUnited KingdomCompleted
The Christie NHS Foundation Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomCompleted
National Cancer Institute of Milan (INT)
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.