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CompletedNCT03961451PODOMETREUpdated May 23, 2019

Number of Weekly Steps, Fatigue, Quality of Life, Well-being During Cancer Treatment: Impact of Recommendations Strengthened by the Provision of Web Interface and Tele-coaching.

An observational study in Cancer, Treatment-Related, sponsored by Institut Paoli-Calmettes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-23.

Sponsored by Institut Paoli-Calmettes · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
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Study summary

study to correlate this level of objective physical activity with the levels of fatigue and quality of life in cancer patient being treated.

Read the detailed description

Study to objectify the level of physical activity of patients by a tool, often used in the global population: the pedometer. Several measurements per questionnaire also will be carried out repeatedly (weekly) in order to correlate this level of objective physical activity with the levels of fatigue and quality of life. The hypothesis we formulate is as follows: the number of weekly steps is negatively correlated with the level of fatigue, positively with the quality of life and well-being.

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Conditions studied

  • Cancer, Treatment-Related

Keywords

  • pedometer
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In context

Neoplasms, Second Primary

247 studies on the registry are indexed under Neoplasms, Second Primary; 48 are open to participants now.

This study's enrollment of 60 is below the median of 290 across 60 observational studies indexed under Neoplasms, Second Primary.

Browse Neoplasms, Second Primary studies →

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Study population

All cancer pathologies, all treatments. Provided that the patient is fit for walking.

Inclusion criteria

  • Patients being treated, Medical Day Hospital / HAD

Exclusion criteria

Exclusion Criteria:

  • Inability to walk declared by an site medical doctor
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Group With Recommendations (GAR)

    Patients in the GAR group will receive several recommendations and will have access to an online tool to increase motivation to engage in physical activity.

    Device: Podometer

  • Control Group (GC)

    No recommendation given

    Device: Podometer

Interventions

  • DevicePodometer

    Patients will be equipped with pedometers for 8 weeks, all day and must complete the number of steps each day. They will have to complete online evaluation questionnaires regularly. The main objective is to correlate the level of physical activity with the level of fatigue, quality of life and well-being weekly during an anticancer treatment.

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What researchers measure

Primary outcomes

  1. Life satisfaction

    Satisfaction With Life Scale (Blais et al, 1989, french-canadian validation, Revue Canadienne des Sciences du Comportement, 21(2), 210-223.)

    Time frame: 2 months

  2. Positive and negative affects measurement

    Positive and Negative Affect Schedule (PANAS scales) (Caci et Baylé, 2007 First traduction in French, Congrès de l'Encéphale, Paris, 25-27 january 2007)

    Time frame: 2 months

  3. Fatigue

    Multidimensional Inventory Fatigue : Gentile et al, 2003, Validation of the French multidimensional fatigue inventory (MFI 20), Eur J Cancer Care)

    Time frame: 2 months

  4. Quality of Life

    European Organisation for Research and Treatment of Cancer Questionnaire Quality of Life version 30

    Time frame: 2 months

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Study locations

1 site
  • Institut Paoli Calmettes
    Marseille, Bouches Du Rhone 13009, France
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References and documents

Publications

  • Villaron C, Cury F, Eisinger F, Cappiello MA, Marqueste T. Telehealth applied to physical activity during cancer treatment: a feasibility, acceptability, and randomized pilot study. Support Care Cancer. 2018 Oct;26(10):3413-3421. doi: 10.1007/s00520-018-4191-4. Epub 2018 Apr 19. PubMed 29675546 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03961451
Lead sponsor
Institut Paoli-Calmettes
Responsible party
Sponsor
First posted
May 23, 2019
Start date
Jan 1, 2016
Primary completion
Dec 31, 2016
Completion
Apr 19, 2018
Last update
May 23, 2019

Study contacts

Maria Cappiello, MD
principal investigator · Institut Paoli-Calmettes

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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