Development and piloting of a decision aid for women considering participation in the Sentinel Node Biopsy versus Axillary Clearance 2 breast cancer trial.
Clin Trials
; 12(4): 409-17, 2015 Aug.
Article
em En
| MEDLINE
| ID: mdl-26033878
ABSTRACT
BACKGROUND/AIMS:
This study aimed to (1) develop a decision aid for women considering participation in the Sentinel Node Biopsy versus Axillary Clearance 2 (SNAC-2) breast cancer surgical trial and (2) obtain evidence on its acceptability, feasibility, and potential efficacy in routine trial clinical practice via a two-stage pilot.METHODS:
The decision aid was developed according to International Patient Decision Aid Standards. Study 1 an initial pilot involved 25 members of the consumer advocacy group, Breast Cancer Network Australia. Study 2 the main pilot involved 20 women eligible to participate in the SNAC-2 trial in New Zealand. In both pilots, a questionnaire assessed information and involvement preferences, decisional conflict, SNAC-2 trial-related understanding and attitudes, psychological distress, and general decision aid feedback. A follow-up telephone interview elicited more detailed feedback on the decision aid design and content.RESULTS:
In both pilots, participants indicated good subjective and objective understanding of SNAC-2 trial and reported low decisional conflict and anxiety. The decision aid was found helpful when deciding about trial participation and provided additional, useful information to the standard trial information sheet.CONCLUSION:
The development and two-stage piloting process for this decision aid resulted in a resource that women found very acceptable and helpful in assisting decision-making about SNAC-2 trial participation. The process and findings provide a guide for developing other trial decision aids.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Participação do Paciente
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Neoplasias da Mama
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Ensaios Clínicos como Assunto
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Técnicas de Apoio para a Decisão
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Biópsia de Linfonodo Sentinela
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article