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

23. december 2015 opdateret af: Philippe Chollet, Centre Jean Perrin

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

251

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Puy de Dome
      • Clermont-Ferrand, Puy de Dome, Frankrig, 63011
        • Centre Jean Perrin
      • Clermont-Ferrand, Puy de Dome, Frankrig, 63100
        • Pole Santé-République

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Ingen indgriben: control
dietary counseling by a dietetician in the anticancer hospital

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of life (SF36)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anxiety/depression scores (HAD)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: during 2 years after inclusion
health related costs, health insurance costs, social costs
during 2 years after inclusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2008

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

22. februar 2012

Først indsendt, der opfyldte QC-kriterier

23. marts 2012

Først opslået (Skøn)

27. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PACThe
  • 2008-A 01606 - 49 (Registry Identifier: AFSSAPS (France))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ikke-metastaserende brystkræft

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