A randomised-controlled trial comparing efficacy of educational materials for treatment-focused genetic testing on women newly diagnosed with breast cancer 

Barlow-Stewart K, Gleeson M, Kirk J, Meiser B (Principal Investigator), Mitchell G, Rahman B, Saunders C, Tucker K, Watts K

​In a previous qualitative pilot study  we explored the attitudes and information needs of women newly diagnosed with breast cancer regarding treatment-focused genetic testing (Zilliacus E et al. Accepted by Supportive Care in Cancer on 10/11/2011). Based upon the findings of the pilot study, we developed and evaluated educational materials (a pamphlet) entitled ‘Making a Decision about Treatment-Focused Genetic Testing’ which is being utilised in the randomised controlled trial (Meiser B et al. Accepted by Oncology Nursing Forum on 20/03/2011). 

This ongoing randomised controlled trial compares the efficacy of educational materials regarding TFGT to that of standard pre-test genetic counselling in preparing women for decision-making about TFGT.  Women are being randomised to receive either educational materials only (intervention group) or standard pre-test genetic counselling at a familial cancer centre (control group).  Eligible women will be aged between 18 and 50 years with early or locally advanced breast cancer and must exhibit at least one of the following risk features: (i) A strong family history of breast and/or ovarian cancer OR (ii) no relevant family history of breast and/or ovarian cancer and presence of: bilateral breast cancer; Ashkenazi Jewish background; and/or a triple negative breast cancer (ER, progesterone receptor and HER2 negative tumour). Eligible women will be invited to the study by their treating breast surgeon.

Secondary aims of the RCT are to: (i) assess the impact of TFGT on uptake of BM and risk-reducing salpingo-oophorectomy (RRSO); (ii) to develop and test in the clinical setting a screening tool to identify eligible patients for TFGT; (iii) to compare the cost effectiveness of two different methods of educating women about TFGT; and (iv) to undertake a process evaluation of TFGT amongst the health professionals involved in the delivery of TFGT.

This will be the first study internationally to compare the efficacy of different educational strategies in informing women newly diagnosed with breast cancer about TFGT.