PODOMETRE: 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.

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Completed

CT.gov ID

NCT03961451

Collaborator

(none)

Enrollment

Location

27.6

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Jan 1, 2016

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Apr 19, 2018

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients being treated, Medical Day Hospital / HAD

Exclusion Criteria:

Inability to walk declared by an site medical doctor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Paoli Calmettes	Marseille	Bouches Du Rhone	France	13009

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

Principal Investigator: Maria Cappiello, MD, Institut Paoli-Calmettes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Paoli-Calmettes

ClinicalTrials.gov Identifier:

NCT03961451

Other Study ID Numbers:

PODOMETRE-IPC 2015-028

First Posted:

May 23, 2019

Last Update Posted:

May 23, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut Paoli-Calmettes

pedometer

Additional relevant MeSH terms:

Neoplasms, Second Primary

Study Results

No Results Posted as of May 23, 2019