Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy

Not Applicable

Terminated

• Conditions: Non Metastatic Breast Cancer
• Interventions: Behavioral: dietaty education, physical training, physiotherapy and SPA cares

• Registration Number: NCT01563588
• Lead Sponsor: Centre Jean Perrin

Brief Summary

Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer.

The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2010-10
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Study Completion: 2013-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 251

Inclusion Criteria

• breast cancer
• treatment including a chemotherapy
• in complete remission
• last treatment in the last 9 months before inclusion
• signed consent

Exclusion Criteria

• metastatic disease
• relapse
• women enable to have physical activity
• heart disease or any pathology preventing physical activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dietary and physical training	dietaty education, physical training, physiotherapy and SPA cares	12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers

Primary Outcome Measures

Name	Time	Method
Quality of life (SF36)	one year after inclusion	Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months. The difference at one year was the main endpoint.

Secondary Outcome Measures

Name	Time	Method
economic figures	during 2 years after inclusion	health related costs, health insurance costs, social costs
Anxiety/depression scores (HAD)	inclusion, 6, 12, 18, 24, 36 months	HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.
Weight and morphometric measures	inclusion, 6, 12, 18, 24, 36 months	Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups
Sleep quality	inclusion, 6, 12, 18, 24, 36 months	6 questions are asked: it rates the delay before sleep onset, the lenght of sleep, the number of awakening, the lenght of wake periods during the night, the concentration/alertness after sleep, and the fatigue in the morning.

Trial Locations

Locations (2)

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, Puy de Dome, France

Pole Santé-République; 🇫🇷 Clermont-Ferrand, Puy de Dome, France