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Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03490604
Acronym
ARABICA
Enrollment
30
Registered
2018-04-06
Start date
2018-07-02
Completion date
2021-10-01
Last updated
2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Pancreatic Adenocarcinoma

Brief summary

Pancreatic cancer is the 5th leading cause of death from cancer in France. When chemotherapy can be proposed, the choice of treatment is currently based on the patient's profile and expected tolerance. The endpoints currently used in trials, such as time to therapeutic failure, do not take into account the patient's experience of the disease. The use of quality of life questionnaires is often proposed, but frequent missing data and filling time can be a problem. In oncology, some studies have demonstrated, through questionnaires, the link between physical activity and quality of life. In this situation, ambulatory measurement of physical activity by wrist actimetry could be an integrative reflection of the impact of the disease and treatment (efficacy, tolerance) on patients. This type of evaluation, if accepted by patients, could usefully complement the measurement of quality of life in this population. No study has specifically looked at the use of devices of this type in the context of digestive cancer. The investigators propose to evaluate the acceptance of this type of device by pancreatic cancer patients receiving chemotherapy before evaluating its potential interest.

Interventions

DEVICEwrist-worn accelerometer

accelerometer worn on the patient's wrist, changed every 15 ± 7 days for 6 months when the patient comes for a chemotherapy session

Questionnaire regarding physical activity over the previous 7 days, questionnaires EORTC QLQ-C30 and EORTC QLQ-PAN26

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient with unresectable pancreatic adenocarcinoma for whom an indication for chemotherapy has been decided upon after a multidisciplinary consultation meeting; * Adult patient; * Patients able to understand spoken and written French, * Patient has given consent.

Exclusion criteria

* WHO ECOG stage III or IV ; * Patient suffering from a major physical disability (hemiplegia, paraplegia, myopathy, amputation of a limb); * Any alteration of comprehension capacities making self-evaluation impossible; * Protected adult; * Patient not affiliated to a national health insurance scheme; * Pregnant or nursing women.

Design outcomes

Primary

MeasureTime frameDescription
average time wearing the accelerometer, in hoursevery 2 weeks for 6 monthsthe amount of time the accelerometer is not worn will be estimated using the standard deviation and range of acceleration in each of the 3 axes, calculated for consecutive 15-minute windows

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026