- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00665782
Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
Stress Measures in Women With Newly Diagnosed Breast Cancer
RATIONALE: Gathering information about how patients respond to stress and measuring stress levels in women with newly diagnosed breast cancer may help doctors provide better methods of treatment and on-going care.
PURPOSE: This research study is measuring stress in women with newly diagnosed stage I, stage II, or stage III breast cancer or ductal carcinoma in situ of the breast.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Autre: laboratoire d'analyse de biomarqueurs
- Procédure: chirurgie conventionnelle thérapeutique
- Autre: gestion des questionnaires
- Procédure: évaluation et prise en charge psychosociale
- Autre: étude des variables socio-économiques et démographiques
- Procédure: évaluation des complications thérapeutiques
Description détaillée
OBJECTIVES:
Primary
- Describe the distributions of physiologic, psychosocial, and behavioral response to stress in women with newly diagnosed breast cancer.
- Describe the patterns of diurnal cortisol rhythms in women newly diagnosed with breast cancer.
Secondary
- Determine if diurnal salivary cortisol (mean or pattern) is consistent over two days within two weeks of study entry.
- Assess the changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion change after an intervening stress event (pre- to post-surgery).
- Determine if the diurnal cortisol rhythm and the night-time urinary excretion correlate with a variety of self-reported psychosocial factors: optimism (LOT-R), state and trait anxiety (STAI form Y-2), positive and negative affect (PANAS), depressive symptoms (CES-D), coping (Brief COPE), and perceived stress (PSS-10).
- Determine if the diurnal cortisol rhythm and the night-time urinary epinephrine excretion correlate with socioeconomic stress and discrimination (functional social support and discrimination [EOD]).
- Determine if the diurnal cortisol rhythm and the night-time urinary epinephrine excretion correlate with one lifestyle behavior and dietary fat consumption (Block food screener).
OUTLINE: Patients are stratified according to race (Caucasian vs African American).
Patients are instructed to collect saliva and urine samples on 2 separate days, within 2 weeks of study enrollment. Saliva samples are collected 6 times a day at baseline, before breast cancer surgery, and 7-10 days after surgery. Urine samples are collected after midnight until and including the first morning sample on the saliva-collection days.
Patients also complete questionnaires (either by telephone interview or in person) within 2 weeks of study enrollment and 7-10 days after breast surgery. Stress measures examined include optimism (LOT-R), trait-anxiety scale (STAI form Y-2), functional social support, affect and depression (PANAS and CES-D), perceived stress (PSS-10), economic hardship scales, discrimination (EOD), coping mechanisms (Brief COPE), and dietary fat consumption (Block Sugar/Fat/Fruit/Vegetable screener).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks
- Surgery for breast cancer planned
- Hormone receptor status not specified
- Female
- Menopausal status not specified
Able to refrain from:
- Smoking cigarettes for the 24-hour period of saliva-sample collection
- Brushing teeth or eating for up to one hour prior to saliva collection
- More than 1 year since prior therapy for another malignancy
- At least 1 month since prior withdrawal from hormone-replacement product
- Able to refrain from steroid inhalers for greater than 24 hours
- No chronic oral steroids
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Autre
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Diurnal cortisol rhythm
Délai: Up to 10 days
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Up to 10 days
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Consistency of diurnal salivary cortisol levels over two days
Délai: Up to 10 days
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Up to 10 days
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Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery
Délai: Up to 10 days
|
Up to 10 days
|
Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses
Délai: Up to 10 days
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Up to 10 days
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Julia A. Lawrence, Wake Forest University Health Sciences
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 (Réel)
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
- IRB00004300
- P30CA012197 (Subvention/contrat des NIH des États-Unis)
- CCCWFU-97307
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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