1362P - Using an informed consent in mammography screening: Final result of a randomized trial

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cancer Aetiology, Epidemiology, Prevention
Imaging, Diagnosis and Staging
Presenter Petra Rosado Varela
Citation Annals of Oncology (2014) 25 (suppl_4): iv478-iv480. 10.1093/annonc/mdu351
Authors P. Rosado Varela1, J.M. Baena Cañada1, P. Ramirez Daffós1, I. Expósito Álvarez1, M. González Guerrero1, E. Benítez Rodriguez1, E. Arriola Arellano2, M.J. Gómez Reina1, C. Cortés Carmona1, S. Estalella Mendoza1, J.A. Contreras Ibáñez1, A. Rueda Ramos1
  • 1Oncología Médica, Hospital universitario Puerta del Mar, 11009 - Cadiz/ES
  • 2Medical Oncology, Hospital Universitario Puerta del Mar, 11009 - Cádiz/ES

Abstract

Aim

In Spain women do not make an informed choice on participation in breast cancer screening. The aim of the study was to evaluate the influence of receiving adequate information on the real benefits and risks of mammography on the level of knowledge of participants in the screening program, and how such information might influence the participants' attitude, decision to participate, anxiety/depression, and worries about cancer.

Methods

A randomized, controlled clinical trial was conducted in a Mammography Screening Program Centre in one local Health District in Spain. 434 women aged between 45 and 69 years called for mammography screening were randomly assigned, 216 to the intervention group (IG), 218 to the control group (CG). Of these 355 were analysed, 177 in the IG and 178 in the CG. At the first interview they received either the information contained in the document created by the Nordic Cochrane Centre on breast cancer screening or the standard information of the program. Specific questionnaires were administered in the second interview within a month. The principal objective was to evaluate participants' level of knowledge on benefits and risks of mammography screening. Secondary objectives were to assess their attitude, decision, anxiety and depression, and worry about cancer (this last item was analysed only in 62 and 59 women respectively due to being included later in the study).

Results

Good knowledge was acquired by 32 of 177 women (18.10%) in the IG, and by 15 of 178 (8.40%) in the CG (p = 0.008). Women of the IG have a relative risk of acquiring good knowledge 2.39 times greater than those of the CG (95% confidence interval 1.24–4.60). No differences were found in any of the secondary objectives.

Basic characteristics of the participants in the control and intervention groups
Characteristics Standard information group N(%) Experimental information group N (%) p value
Score on the knowledge questionnaire. Mean (SD) 2.97 (1.08) 2.96 (1.23) 0.930
Score on the attitude questionnaire. Mean (SD) 3.17 (2.69) 3.26 (2.62) 0.720
Score on the Hospital Anxiety and Depression Scale. Mean (SD) Anxiety Depression 1.94 (3.52) 1.78 (3.00) 0.620
0.76 (2.15) 0.69 (1.84) 0.710
Score on the Cancer Worry Scale. Mean (SD) 9.92 (3.28) 8.87 (2.69) 0.056
Decision Decided 218 (100) 216 (100) 1.000

Conclusions

Women receiving information based on the Nordic Cochrane Centre document were better informed. This means of providing information on mammography screening is not very efficacious for helping women to decide, nor does it modify attitude, decision, feelings or worries about cancer.

Disclosure

All authors have declared no conflicts of interest.