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Completed

NCT Number: NCT03490604

Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

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.

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Key information

Conditions

Unresectable Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

wrist-worn accelerometer

Device

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

Auto-questionnaires

Other

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

Primary outcomes

  1. average time wearing the accelerometer, in hours

    Time frame: every 2 weeks for 6 months

    the 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: ARABICA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2018
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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