Group medical visits in the follow-up of women with a BRCA mutation: design of a randomized controlled trial

In this randomized controlled trial, 160 BRCA mutation carriers diagnosed maximally 2 years ago are recruited from the Radboud University Nijmegen Medical Centre. Participants are randomized in a 1:1 ratio to either the GMC intervention group (onetime participation in a GMC instead of a standard individual visit) or to a usual care control group. Primary outcome measures are empowerment and psychological distress (SCL 90). Secondary outcome measures are fear of cancer, information needs before the consultation and the received information, self-examination of the breasts, patient satisfaction, quality of life and cost-effectiveness. Data are collected via self-reported questionnaires 1 week before the visit, and at 1 week and at 3 months follow-up. A pilot study was conducted to test all procedures and questionnaires.The possibility for interaction with other BRCA mutation carriers within a medical visit is unique. This study will assess the effectiveness of GMCs for BRCA mutation carriers to improve empowerment and decrease distress compared to individual visits. If GMCs prove to be effective and efficient, implementation of GMCs in regular care for BRCA mutation carriers will be recommended.The study is registered at ClinicalTrials.gov (NCT01329068)BRCA mutation carriers have a high life-time risk of developing breast cancer and also of ovarian cancer. In a large meta-analysis of ten studies the mean cumulative breast cancer risk at 70 years was 46-80% for BRCA1 mutation carriers and 40-80% for BRCA2 mutation carriers [1-3]. Because of this high risk of breast cancer, women with a mutation in either the BRCA1 or BRCA2 gene are offered breast cancer surveillance, which includes annual clinical breast examination, annual mammography and annual contrast enhanced magnetic resonance imaging (MRI) of the breast [4-6]. Alternatively, women may opt for prophylactic bilateral mastectomy with or without breast reconstruction [7-10]. Prophylactic bilateral mastectomy reduces