REduction of Physical Inactivity Facing the CAncer

Breast Cancer Clinical Trial

— RESCA  

Official title:

Physical Activity in Patients With Cancer: Epidemiological Study of Patients' Beliefs and Promotional Messages Efficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867475
• Other study ID #: 2013/03 RESCA
• Status: Completed
• Phase: N/A
• First received: August 11, 2016
• Last updated: August 16, 2016
• Start date: October 2013
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Study 1:

The investigator hypothesizes that the level of knowledge about the benefits of physical activity, physical activity level and physical fatigue level observed in cancer patients, would influence their beliefs about physical activity and their intention to engage in AP.

Description:

Study 2:

Because of a recent research, it is shown that a narrative message from a peer generates an identification, a sense of self-efficacy and intention to practice in sedentary patients with breast cancer.

The investigator hypothesize that a promotional message about physical activity, issued by a self-determined peer (intrinsic motivation), compared to a non-self-determined peer (extrinsic motivation), generate higher scores of positive beliefs about physical activity and intention to engage in a physical activity program for sedentary patients.

These promotional messages will be delivered through two videos, one featuring the self-determined pair, the other featuring the non-self-determined pair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• PS 0-3

• Patients with breast cancer undergoing chemotherapy treatment

• neoadjuvant, adjuvant, metastatic, any histological type, any stage breast cancer

• Sedentary Patients (physical activity score of Dijon less than or equal to 20)

Exclusion Criteria:

• Patients with PS greater than 3

• Patients with cognitive disorders not allowing them to understand the questionnaires and study procedures

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Physical activity motivation
Physical activity motivation

Locations

Country	Name	City	State
France	Centre Antoine LACASSAGNE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CaBES	psychometric measures: Cancer Beliefs and Exercise Scale Questionnaire	1 day	No
Secondary	Multidimensional Fatigue Inventory	Fatigue level determination	1 day	No
Secondary	Dijon's Score	Physical activity level determination	1 day	No