Non Metastatic Breast Cancer
Conditions
Keywords
breast cancer, chemotherapy, first line treatment, treatments include a chemotherapy, last treatment not performed more than 9 months earlier
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.
Interventions
BEHAVIORALdietaty education, physical training, physiotherapy and SPA cares
12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
Sponsors
Centre Jean Perrin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| economic figures | during 2 years after inclusion | health related costs, health insurance costs, social costs |
Countries
France
Outcome results
None listed