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

NCT ID: NCT06868355

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-28

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention (observational study)

This is an observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Christie NHS Foundation Trust

OTHER

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Donna Graham

Medical Oncology Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Institute of Milan (INT)

Milan, , Italy

Site Status RECRUITING

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, , Spain

Site Status RECRUITING

START Madrid CIOCC

Madrid, , Spain

Site Status NOT_YET_RECRUITING

START Madrid Fundación Jiménez Díaz (FJD) Quiron Salud Hospital

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status RECRUITING

Instituto de Investigación Sanitaria (INCLIVA)

Valencia, , Spain

Site Status RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Site Status COMPLETED

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status COMPLETED

Countries

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Italy Spain United Kingdom

Central Contacts

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Gayle Patterson

Role: CONTACT

07919719013

Subir Singh

Role: CONTACT

Facility Contacts

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Matteo Duca

Role: primary

0223903650

Elena Garralda

Role: primary

+34 932 54 34 50

Irene Moreno

Role: primary

(+34) 911 23 99 66

Victor Moreno

Role: primary

(+34) 91 550 48 00

Mariano Ponz Sarvisé

Role: primary

+34 948 25 54 00

Andrés Cervantes Ruipérez

Role: primary

+34 626 85 87 57

Other Identifiers

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311863

Identifier Type: OTHER

Identifier Source: secondary_id

NHS002002

Identifier Type: -

Identifier Source: org_study_id

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