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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-A 01606 - 49 | Registry Identifier | AFSSAPS (France) |
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Enrollment lasted longer than expected and expected number of patients could not be matched in time.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dietary and physical training | Experimental | 12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers |
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| control | No Intervention | dietary counseling by a dietetician in the anticancer hospital |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietaty education, physical training, physiotherapy and SPA cares | Behavioral | 12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | Puy de Dome | 63011 | France | ||
| Pole Santé-République |
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| Label | URL |
|---|---|
| URL to Centre Jean Perrin main page | View source |
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| 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 |
| Clermont-Ferrand |
| Puy de Dome |
| 63100 |
| France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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