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

NCT06868355 | Recruiting

• 2 other identifiers: NHS002002311863
• Study Type: observational
• Target: 40
• Locations: 3 countries
• Sites: 8

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Overall daily patient physical activity across 24 hours measured in millgravity

  From baseline for a period of 4-8 weeks

• Time spent in inactivity (total and in >30 minute periods over 24 hours)

  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

  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

  From baseline for a period of 4-8 weeks

• Patient self-reported physical activity level (captured from questionnaire)

  From baseline for a period of 4-8 weeks

Interventions

No intervention (observational study) OTHER

This is an observational study

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• The Christie NHS Foundation Trust: collaborator
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (8)

National Cancer Institute of Milan (INT)

Milan, Italy

RECRUITING

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, Spain

RECRUITING

START Madrid CIOCC

Madrid, Spain

NOT YET RECRUITING

START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital

Madrid, Spain

NOT YET RECRUITING

Clínica Universidad de Navarra

Pamplona, Spain

RECRUITING

Instituto de Investigación Sanitaria (INCLIVA)

Valencia, Spain

RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

COMPLETED

The Christie NHS Foundation Trust

Manchester, United Kingdom

COMPLETED

MeSH Terms

Conditions

Neoplasms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Gayle Patterson

CONTACT

07919719013; gayle.patterson@manchester.ac.uk

Subir Singh

CONTACT

subir.singh@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncology Consultant

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 10, 2025
• Study Start: September 28, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-07

Locations

GB (2); IT (1); ES (5)