Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial.
Br J Cancer
; 111(1): 1-7, 2014 Jul 08.
Article
en En
| MEDLINE
| ID: mdl-24892447
BACKGROUND: Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. METHODS: The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). RESULTS: Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. CONCLUSIONS: This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Participación del Paciente
/
Neoplasias de la Mama
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Ensayos Clínicos Controlados Aleatorios como Asunto
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Técnicas de Apoyo para la Decisión
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Toma de Decisiones
Tipo de estudio:
Clinical_trials
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Prognostic_studies
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Qualitative_research
Aspecto:
Patient_preference
Límite:
Female
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Humans
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Middle aged
Idioma:
En
Revista:
Br J Cancer
Año:
2014
Tipo del documento:
Article
País de afiliación:
Australia
Pais de publicación:
Reino Unido