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Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients (ARABICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490604
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment
Unresectable Pancreatic Adenocarcinoma Device: wrist-worn accelerometer Other: Auto-questionnaires

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: wrist-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
  • Other: Auto-questionnaires
    Questionnaire regarding physical activity over the previous 7 days, questionnaires EORTC QLQ-C30 and EORTC QLQ-PAN26


Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients followed in the hospital unit
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490604


Locations
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France
Chu Dijon Bourogne Recruiting
Dijon, France, 21000
Contact: Antoine DROUILLARD    03.80.29.37.50    antoine.drouillard@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03490604    
Other Study ID Numbers: DROUILLARD AOI 2017
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms