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
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2018
CompletedFirst Submitted
Initial submission to the registry
May 21, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedMay 23, 2019
May 1, 2019
1 year
May 21, 2019
May 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Life satisfaction
Satisfaction With Life Scale (Blais et al, 1989, french-canadian validation, Revue Canadienne des Sciences du Comportement, 21(2), 210-223.)
2 months
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)
2 months
Fatigue
Multidimensional Inventory Fatigue : Gentile et al, 2003, Validation of the French multidimensional fatigue inventory (MFI 20), Eur J Cancer Care)
2 months
Quality of Life
European Organisation for Research and Treatment of Cancer Questionnaire Quality of Life version 30
2 months
Study Arms (2)
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.
Control Group (GC)
No recommendation given
Interventions
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.
Eligibility Criteria
All cancer pathologies, all treatments. Provided that the patient is fit for walking.
You may qualify if:
- Patients being treated, Medical Day Hospital / HAD
You may not qualify if:
- Inability to walk declared by an site medical doctor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, 13009, France
Related Publications (1)
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.
PMID: 29675546RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Cappiello, MD
Institut Paoli-Calmettes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2019
First Posted
May 23, 2019
Study Start
January 1, 2016
Primary Completion
December 31, 2016
Study Completion
April 19, 2018
Last Updated
May 23, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share