Abstract
BackgroundBRCA mutation carriers have a 40-80% life-time risk of developing breast cancer. They may opt for yearly breast cancer surveillance or for prophylactic mastectomy. Both options show increased survival rates. It is a complex choice to be made between these two options. As a result most women experience high levels of distress and high needs for information. To fulfill the needs for psychosocial support and information we have introduced group medical consultations (GMCs). A GMC provides individual medical visits conducted within a group. This 90 minute group-visit with 8-12 patients gives patients the opportunity to spend more time with their clinician and a behavioral health professional and learn from other patients experiencing similar topics. However, it should be noted that group sessions may increase fear in some patients or influence their decision making.Methods/designIn 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.DiscussionThe 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.Trial registrationThe study is registered at ClinicalTrials.gov (NCT01329068)
Highlights
BRCA mutation carriers have a 40-80% life-time risk of developing breast cancer
This study will assess the effectiveness of group medical consultations (GMCs) for BRCA mutation carriers to improve empowerment and decrease distress compared to individual visits
To fulfill the needs just mentioned concerning psychosocial support and information we have introduced group medical consultations (GMCs) for the surveillance of BRCA mutation carriers
Summary
BRCA mutation carriers have a 40-80% life-time risk of developing breast cancer. They may opt for yearly breast cancer surveillance or for prophylactic mastectomy. BRCA mutation carriers have a high life-time risk of developing breast cancer and of ovarian cancer. Most studies among BRCA mutation carriers who had breast cancer have shown a reduction in the risk of contralateral breast cancer, while results on survival rates were diverse [10,13,14,15]. The knowledge of BRCA carriership and the increased risk of developing breast (and ovarian) cancer may have a large psychosocial impact on mutation carriers. Several studies in the Netherlands showed that genetic testing, regardless of the test results may already increase levels of distress [19,20]
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