Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

NCT03490604 | Completed

• 1 other identifier: DROUILLARD AOI 2017
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• average time wearing the accelerometer, in hours

  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

  every 2 weeks for 6 months

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients followed in the hospital unit

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 6, 2018
• Study Start: July 2, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

FR (1)