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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Puy de Dome
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Clermont-Ferrand, Puy de Dome, Frankrijk, 63011
- Centre Jean Perrin
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Clermont-Ferrand, Puy de Dome, Frankrijk, 63100
- Pole Santé-République
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
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12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
|
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Geen tussenkomst: control
dietary counseling by a dietetician in the anticancer hospital
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quality of life (SF36)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Anxiety/depression scores (HAD)
Tijdsspanne: inclusion, 6, 12, 18, 24, 36 months
|
HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.
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inclusion, 6, 12, 18, 24, 36 months
|
|
Weight and morphometric measures
Tijdsspanne: inclusion, 6, 12, 18, 24, 36 months
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Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups
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inclusion, 6, 12, 18, 24, 36 months
|
|
Sleep quality
Tijdsspanne: inclusion, 6, 12, 18, 24, 36 months
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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.
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inclusion, 6, 12, 18, 24, 36 months
|
|
economic figures
Tijdsspanne: during 2 years after inclusion
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health related costs, health insurance costs, social costs
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during 2 years after inclusion
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PACThe
- 2008-A 01606 - 49 (Register-ID: AFSSAPS (France))
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