- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00012935
Treatment Decision Intervention for Veterans With Prostate Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background:
Newly diagnosed localized prostate cancer patients face difficult decisions about treatment and management; including radiation therapy, radical prostatectomy, brachytherapy, and observation. Previous studies have cited patient preference and physician recommendation for treatment as major roles in treatment decisions.
Objectives:
This grant will be used to develop and evaluate a decision analysis based intervention to improve decision-making among veterans with newly diagnosed localized prostate cancer. While the ultimate goal of this study is to improve decision-making among these patients, factors influencing physician recommendations for treatment will be sought. The former will be achieved by evaluating the efficacy of providing physicians with information incorporating patient preference for alternative health states with probabilities of treatment outcomes. Factors influencing physician recommendations for treatment will be determined through qualitative interviews with physicians.
Methods:
Patients were accrued at the VA Chicago Health Care System Lakeside Urology Clinic. Upon consent for participation in the study, comorbidities, histologic grade of the biopsy, and age were obtained for 13 patients with newly diagnosed localized prostate cancer. Using a standard gamble technique, interviewers obtained patient utilities for 5 distinct health states related to prostate cancer treatment. Clinical and pathologic characteristics were incorporated into the decision analytic model, and the derived quality-adjusted life expectancies (QALEs) were shared with the treating urologist before patient-physician discussion of treatment options. The feasibility of the decision analytic intervention and unbiased estimates of the impact of the intervention was evaluated. The long-range objective of this proposal is to design an intervention for veterans that increases physician understanding of patient treatment preferences and patient understanding of choices in prostate cancer treatment.
Status:
Completed
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
1) biopsy confirmed diagnosis of localized prostate cancer; 2) newly diagnosed-no prior treatment (including watchful waiting) or discussion with their prior physicians about treatment options; 3) no previous neoplasms in the last five years, with the exception of basal cell cancer of the skin; 4) speak english; 5) no major psychiatric disorder that would preclude their participation; 6) be between 50 and 80 years of age.
Exclusion Criteria:
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Bras 1
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Charles L. Bennett, MD PhD MPP, Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
- Chercheur principal: Sara J. Knight, PhD, Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PCI 99-159
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