Factors Correlated With Fatigue in Breast Cancer (FATSEIN)
5. februar 2010 opdateret af: Central Hospital, Nancy, France
Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy
The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored.
A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to meet the study aims.
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
557
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Dijon, Frankrig, 21 000
- Rekruttering
- Centre Georges Francois Leclerc
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Kontakt:
- Rotonda Christine, PhD student
- Telefonnummer: +33 3 83 59 85 74
- E-mail: christine.rotonda@hotmail.fr
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Ledende efterforsker:
- Bonnetain Franck
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Strasbourg, Frankrig, 67 000
- Rekruttering
- Centre Paul Strauss
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Kontakt:
- Rotonda Christine, PhD student
- Telefonnummer: +33 3 83 59 85 74
- E-mail: christine.rotonda@hotmail.fr
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Ledende efterforsker:
- Velten Michel
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Meurthe et Moselle
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Vandoeuvre-les-Nancy, Meurthe et Moselle, Frankrig, 54 511
- Rekruttering
- Centre Alexis Vautrin
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Kontakt:
- Rotonda Christine, PhD student
- Telefonnummer: +33 3 83 59 85 74
- E-mail: christine.rotonda@hotmail.fr
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Ledende efterforsker:
- Conroy Thierry, PU-PH
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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 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Recruitment began in September 2008 and is planned over a 24-month period.
Participants with breast cancer are recruited from three French cancer centers, the Alexis Vautrin anti-cancer center of Vandoeuvre-les-Nancy, the Georges-François Leclerc anti-cancer center of Dijon and the Paul Strauss anti-cancer center of Strasbourg, France.
Participation to study is proposed to all women with newly diagnosed breast cancer the day preceeding surgery.Included patients are asked to complete the questionnaires several times.
Beskrivelse
Inclusion Criteria:
- aged 18 years and older
- newly diagnosed with stage I-IIIA breast adenocarcinoma
- have undergone surgery
- WHO performance status score equal or lower than 2
- able to provide informed consent
- speak French and able to complete self-report questionnaires
Exclusion Criteria:
- pregnancy
- bilateral breast cancer
- metastatic breast cancer
- patients who received neoadjuvant chemotherapy
- known psychiatric disease or dementia
- no previous history of cancer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Chemotherapy group
Breast cancer patients treated by adjuvant chemotherapy after their surgery.
The time points of data collection are before the start of the first, second, fourth and sixth cycle of chemotherapy.
If patients are treated by radiotherapy after the chemotherapy, there are 2 measurements points pre- and post radiotherapy.The others measurement points are at 12,18 and 24 months after surgery.
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No chemotherapy group
Breast cancer patients no treated by adjuvant chemotherapy after their surgery.
For patients treated by radiotherapy after surgery, there are 2 measurement points pre- and post radiotherapy.
The others measurement points are at 4,6,7,8,12,18 and 24 months after surgery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue.
Tidsramme: Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment
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Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Questionnaires regarding personality traits (LOT "Life Orientation Test" and the trait-version of the STAI "State Trait Anxiety instrument"), Quality of life questionnaire(EORTC QLQ-C30), and the state-version of the STAI will be also completed.
Tidsramme: For the LOT and the trait-version of the STAI: only before the surgery, for the QLQ-C30: before surgery and several times during adjuvant treatment and for the state-version of the STAI: several times during adjuvant treatment
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For the LOT and the trait-version of the STAI: only before the surgery, for the QLQ-C30: before surgery and several times during adjuvant treatment and for the state-version of the STAI: several times during adjuvant treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Guillemin Francis, PU-PH, Inserm, CIC-EC CIE6, Nancy; CHU Nancy
- Ledende efterforsker: Conroy Thierry, PU-PH, Centre Alexis Vautrin, Department of Medical Oncology, Vandoeuvre-les-Nancy, France
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. juli 2008
Primær færdiggørelse (Forventet)
1. september 2012
Studieafslutning (Forventet)
1. september 2012
Datoer for studieregistrering
Først indsendt
5. februar 2010
Først indsendt, der opfyldte QC-kriterier
5. februar 2010
Først opslået (Skøn)
8. februar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. februar 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. februar 2010
Sidst verificeret
1. februar 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 08-FATQV
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 .