Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

NCT ID: NCT03490604

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-02
• Study Completion Date: 2021-10-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DEVICE

Auto-questionnaires

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Countries

France

Other Identifiers

DROUILLARD AOI 2017

Identifier Type: -

Identifier Source: org_study_id