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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. (PODOMETRE)

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ClinicalTrials.gov Identifier: NCT03961451
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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

Condition or disease Intervention/treatment
Cancer, Treatment-Related Device: Podometer

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.
Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : April 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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.
Control Group (GC)
No recommendation given
 Device: Podometer
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.


Outcome Measures
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Primary Outcome Measures :
  1. Life satisfaction [ Time Frame: 2 months ]
    Satisfaction With Life Scale (Blais et al, 1989, french-canadian validation, Revue Canadienne des Sciences du Comportement, 21(2), 210-223.)

  2. Positive and negative affects measurement [ Time Frame: 2 months ]
    Positive and Negative Affect Schedule (PANAS scales) (Caci et Baylé, 2007 First traduction in French, Congrès de l'Encéphale, Paris, 25-27 january 2007)

  3. Fatigue [ Time Frame: 2 months ]
    Multidimensional Inventory Fatigue : Gentile et al, 2003, Validation of the French multidimensional fatigue inventory (MFI 20), Eur J Cancer Care)

  4. Quality of Life [ Time Frame: 2 months ]
    European Organisation for Research and Treatment of Cancer Questionnaire Quality of Life version 30


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  • Patients being treated, Medical Day Hospital / HAD

Exclusion Criteria:

  • Inability to walk declared by an site medical doctor
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961451


Locations
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France
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Maria Cappiello, MD Institut Paoli-Calmettes
More Information
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Publications of Results:

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03961451    
Other Study ID Numbers: PODOMETRE-IPC 2015-028
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Paoli-Calmettes:
pedometer
Additional relevant MeSH terms:
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Neoplasms, Second Primary
Neoplasms