Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy
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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Puy de Dome
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Clermont-Ferrand, Puy de Dome, France, 63011
- Centre Jean Perrin
-
Clermont-Ferrand, Puy de Dome, France, 63100
- Pole Santé-République
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: dietary and physical training
12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
|
12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
|
|
Aucune intervention: control
dietary counseling by a dietetician in the anticancer hospital
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of life (SF36)
Délai: 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.
|
one year after inclusion
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety/depression scores (HAD)
Délai: inclusion, 6, 12, 18, 24, 36 months
|
HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.
|
inclusion, 6, 12, 18, 24, 36 months
|
|
Weight and morphometric measures
Délai: inclusion, 6, 12, 18, 24, 36 months
|
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
Délai: 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.
|
inclusion, 6, 12, 18, 24, 36 months
|
|
economic figures
Délai: during 2 years after inclusion
|
health related costs, health insurance costs, social costs
|
during 2 years after inclusion
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PACThe
- 2008-A 01606 - 49 (Identificateur de registre: AFSSAPS (France))
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