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.

Completed

• Conditions: Cancer, Treatment-Related
• Interventions: Device: Podometer

• Registration Number: NCT03961451
• Lead Sponsor: Institut Paoli-Calmettes

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.

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2018-04-19
• Status Verified: 2019-05
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients being treated, Medical Day Hospital / HAD

Exclusion Criteria

• Inability to walk declared by an site medical doctor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group (GC)	Podometer	No recommendation given
Group With Recommendations (GAR)	Podometer	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.

Primary Outcome Measures

Name	Time	Method
Life satisfaction	2 months	Satisfaction With Life Scale (Blais et al, 1989, french-canadian validation, Revue Canadienne des Sciences du Comportement, 21(2), 210-223.)
Positive and negative affects measurement	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)
Fatigue	2 months	Multidimensional Inventory Fatigue : Gentile et al, 2003, Validation of the French multidimensional fatigue inventory (MFI 20), Eur J Cancer Care)
Quality of Life	2 months	European Organisation for Research and Treatment of Cancer Questionnaire Quality of Life version 30

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhone, France