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

Study Overview
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Brief Summary
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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.

Official Title
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Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care

Conditions
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Non Metastatic Breast Cancer

Intervention / Treatment
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* Behavioral: dietaty education, physical training, physiotherapy and SPA cares


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dietary and physical training<br>12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers | Behavioral: dietaty education, physical training, physiotherapy and SPA cares<br>* 12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers<br>|
| No Intervention: control<br>dietary counseling by a dietetician in the anticancer hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (SF36) | 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. | one year after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety/depression scores (HAD) | HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire. | inclusion, 6, 12, 18, 24, 36 months | 
| Weight and morphometric measures | Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups | inclusion, 6, 12, 18, 24, 36 months | 
| Sleep quality | 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. | inclusion, 6, 12, 18, 24, 36 months | 
| economic figures | health related costs, health insurance costs, social costs | during 2 years after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, chemotherapy, first line treatment, treatments include a chemotherapy, last treatment not performed more than 9 months earlier