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)
May 22, 2019 updated by: Institut Paoli-Calmettes
study to correlate this level of objective physical activity with the levels of fatigue and quality of life in cancer patient being treated.
Study Overview
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 Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bouches Du Rhone
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Marseille, Bouches Du Rhone, France, 13009
- Institut Paoli Calmettes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All cancer pathologies, all treatments.
Provided that the patient is fit for walking.
Description
Inclusion Criteria:
- Patients being treated, Medical Day Hospital / HAD
Exclusion Criteria:
- Inability to walk declared by an site medical doctor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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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Control Group (GC)
No recommendation given
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life satisfaction
Time Frame: 2 months
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Satisfaction With Life Scale (Blais et al, 1989, french-canadian validation, Revue Canadienne des Sciences du Comportement, 21(2), 210-223.)
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2 months
|
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Positive and negative affects measurement
Time Frame: 2 months
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Positive and Negative Affect Schedule (PANAS scales) (Caci et Baylé, 2007 First traduction in French, Congrès de l'Encéphale, Paris, 25-27 january 2007)
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2 months
|
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Fatigue
Time Frame: 2 months
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Multidimensional Inventory Fatigue : Gentile et al, 2003, Validation of the French multidimensional fatigue inventory (MFI 20), Eur J Cancer Care)
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2 months
|
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Quality of Life
Time Frame: 2 months
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European Organisation for Research and Treatment of Cancer Questionnaire Quality of Life version 30
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2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria Cappiello, MD, Institut Paoli-Calmettes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
April 19, 2018
Study Registration Dates
First Submitted
May 21, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (Actual)
May 23, 2019
Study Record Updates
Last Update Posted (Actual)
May 23, 2019
Last Update Submitted That Met QC Criteria
May 22, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PODOMETRE-IPC 2015-028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.