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CompletedNCT03490604ARABICAUpdated Jan 26, 2022

Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

An observational study in Unresectable Pancreatic Adenocarcinoma, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-26.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Unresectable Pancreatic Adenocarcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients followed in the hospital unit

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • Devicewrist-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

  • OtherAuto-questionnaires

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

05

What researchers measure

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

    Time frame: every 2 weeks for 6 months

06

Study locations

1 site
  • Chu Dijon Bourogne
    Dijon, 21000, France
07

Registry details

Key details

Study ID
NCT03490604
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Apr 6, 2018
Start date
Jul 2, 2018
Primary completion
Oct 1, 2021
Completion
Oct 1, 2021
Last update
Jan 26, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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