- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03333122
Évaluation de la satisfaction des patientes atteintes d'un cancer du sein et des résultats de qualité de vie liés à la santé
Évaluation prospective des résultats signalés par les patients et de la satisfaction à l'égard de l'éducation chez les patientes atteintes d'un cancer du sein (PROS)
The purpose of the study is to learn more about the quality of life and satisfaction with breast cancer surgical treatment and education from patient reported outcome data. The data and information obtained from breast cancer patients can be invaluable in counselling patients with a new diagnosis of breast cancer on their expected outcomes and results. The hypothesis is that using prospectively obtained data to guide surgical decision-making and optimize access to surgical procedures would improve the treatment of patients and would most likely positively impact the health-related quality of life in patients.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This study will be a prospective observational study of women with newly diagnosed breast cancer. To date, there is little data in the literature assessing and comparing the outcomes associated with breast cancer surgical procedures. Information of satisfaction of patients with treatment, result, and breast cancer education they receive is particularly deficient. Therefore, breast cancer female patients will be recruited at Henry Ford Health System. Participants will voluntarily complete surveys electronically at specific points during their treatment and recovery process. Responses and satisfaction of quality of life will be collected and analyzed.
The BREAST-Q survey will be used to obtain patient reported outcomes.The surveys will be given preoperatively, at six months, one year, two years, and five years. Specific surveys will be given to the patients based on the treatment modality they receive.The groups are breast conserving therapy, mastectomy along, and mastectomy with reconstruction.The mastectomy with reconstruction group will be further subdivided based on implant or autologous tissue reconstruction. A survey adapted from the 'Patient Satisfaction with Cancer Treatment Education (PS-CaTE)' questionnaire will be administered at the preoperative and one year time point to evaluate satisfaction with their breast cancer education. PS-CaTE consists of two parts. Part one evaluates the patient's perception of the breast cancer education. Part two serves to elucidate the primary information sources the patients utilized by the patients. A demographic survey will also be given to patients preoperatively and postoperatively. Survey results will be analyzed to detect differences in health-related quality of life among the different treatments.
BREAST-Q surveys are health-related quality of life survey instruments developed to allow validated and reliable acquisition of patient reported outcomes.These surveys were meticulously crafted following internationally accepted guidelines as established by the Scientific Advisory Committee of the Medical Outcomes Trust and the U.S. Food and Drug Administration. The item list of this survey was developed from patient interviews, focus groups, expert panels, and literature review. Separate modules were developed for each treatment modality and include BREAST-Q Breast Conserving Therapy, BREAST-Q Mastectomy, BREAST-Q Reconstruction. These surveys have been used in major trials including the United Kingdom's National Health Service survey of 8,000 patients with mastectomy and mastectomy with reconstruction and FDA surveillance and longitudinal follow-up of patients with silicone breast implants.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Health System
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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
The population consists of adult female patients who are diagnosed with breast cancer will be recruited from the Multidisciplinary Clinic at Henry Ford Health System.
La description
Inclusion Criteria:
- Patients having surgery for breast cancer
- Treatment must be performed within the Henry Ford Health System
- Patients must be at least 18 years of age
Exclusion Criteria:
- Male gender
- Patients with non-operative management of breast cancer
- Patients who are unable to complete the surveys, either by choice or because of limited English, Spanish, or Arabic proficiency
- Patients who are unable to complete a preoperative survey
- Patients with Stage IV or metastatic disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
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Breast Conserving Therapy
Patient who undergo breast conserving therapy or breast conserving therapy with oncoplastic therapies will complete the BREAST-Q Lumpectomy survey module. |
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Mastectomy
Patients who undergo mastectomy will complete the BREAST-Q Mastectomy survey module. |
|
Mastectomy with Reconstruction
Patient who undergo breast reconstruction will complete the BREAST-Q Reconstruction survey module. This group will be further subdivided based on implant or autologous tissue reconstruction. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Compare health-related quality of life outcomes using condition specific surveys among women undergoing breast conserving therapy, mastectomy alone, or mastectomy with reconstruction
Délai: Up to 5 Years
|
The BREAST-Q survey is used to determine differences in health-related of life between treatment groups. |
Up to 5 Years
|
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Compare patient satisfaction with their treatment and result among women undergoing breast conserving therapy, mastectomy alone, or mastectomy with reconstruction
Délai: Up to 5 Years
|
The BREAST-Q survey is used to detect differences in patient satisfaction among the groups. |
Up to 5 Years
|
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Determine the effect of time on patient reported outcomes
Délai: Up to 5 Years
|
Survey responses will be compared across time. |
Up to 5 Years
|
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Patient satisfaction with breast cancer education and compare with source of information and socioeconomic status
Délai: Up to 1 Year
|
PS-CaTE survey is administered to assess patient satisfaction with breast cancer education. |
Up to 1 Year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jenna Luker, MD, Henry Ford Health System
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Autres numéros d'identification d'étude
- 11056
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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