- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03333122
Valutazione della soddisfazione dei pazienti affetti da cancro al seno e della qualità della vita correlata alla salute
Valutazione prospettica degli esiti riferiti dai pazienti e della soddisfazione per l'educazione nei pazienti affetti da carcinoma mammario (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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Michigan
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Health System
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
|---|
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Compare health-related quality of life outcomes using condition specific surveys among women undergoing breast conserving therapy, mastectomy alone, or mastectomy with reconstruction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 5 Years
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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
Lasso di tempo: Up to 1 Year
|
PS-CaTE survey is administered to assess patient satisfaction with breast cancer education. |
Up to 1 Year
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jenna Luker, MD, Henry Ford Health System
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 11056
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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