Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

Unresectable Pancreatic Adenocarcinoma Clinical Trial

— ARABICA  

Official title:

Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490604
• Other study ID #: DROUILLARD AOI 2017
• Status: Completed
• Start date: July 2, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Unresectable Pancreatic Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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