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.

Cancer, Treatment-Related Clinical Trial

— PODOMETRE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961451
• Other study ID #: PODOMETRE-IPC 2015-028
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: April 19, 2018

Study information

• Verified date: May 2019
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 19, 2018
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients being treated, Medical Day Hospital / HAD

Exclusion Criteria:

• Inability to walk declared by an site medical doctor

Related Conditions & MeSH terms

• Cancer, Treatment-Related
• Fatigue
• Neoplasms, Second Primary

Intervention

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.

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & 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/s00520-018-4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Fatigue	Multidimensional Inventory Fatigue : Gentile et al, 2003, Validation of the French multidimensional fatigue inventory (MFI 20), Eur J Cancer Care)	2 months
Primary	Quality of Life	European Organisation for Research and Treatment of Cancer Questionnaire Quality of Life version 30	2 months