Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

Completed

• Conditions: Unresectable Pancreatic Adenocarcinoma

• Registration Number: NCT03490604
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-03-30
• Study First Posted: 2018-04-06
• Study Start: 2018-07-02
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
average time wearing the accelerometer, in hours	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

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France