Wevers, M.R., Ausems, M.G., Verhoef, S., Bleiker, E.M., Hahn, D.E., Brouwer, T., . . . Aaronson, N.K. (2015). Does rapid genetic counseling and testing in newly diagnosed breast cancer patients cause additional psychosocial distress? Results from a randomized clinical trial. Genetics in Medicine, 18, 137–144.

To assess the psychosocial impact of rapid genetic testing and counseling among women with newly diagnosed breast cancer

Patients were randomly assigned to rapid genetic counseling and testing (RGTC) or usual care control groups. Those in the RGTC group were offered an appointment with a clinical geneticist within five working days, and rapid DNA testing with results were provided within about four weeks. Participants complete study measures at baseline, and at 6- and 12-month follow-ups.

• N = 240  
• MEAN AGE: 44.85 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Most were in stage I or stage II breast cancer. About 10% had a prior history of breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: About 50% had at least come college education.

• SITE: Multi-site  
• SETTING TYPE: Not specified    
• LOCATION: Netherlands

PHASE OF CARE: Diagnostic

• Randomized, controlled trial

• Cancer-Worries Scale
• Decisional Conflict Scale (DCS)
• European Organization for Research and Treatment of Cancer Cancer Quality of Life Core 30 (EORTC QLQ-C30)
• EORTC QLQ-BR-2
• Hospital Anxiety and Depression Scale (HADS)
• Satisfaction with decision scale (SWD)

Ninety-six percent of those in the experimental group had genetic counseling consultation, and 33% had DNA testing prior to surgery. In the usual care group, 71% had genetic counseling and 62% had DNA testing, 10% prior to surgery. There were no differences between groups in worries, anxiety, depression, quality of life (QOL), decisional conflict, or satisfaction with decision-making. In both groups, worries and measures of psychosocial distress declined over time.

• Risk of bias (no blinding)
• Other interventions that might impact anxiety and distress were not identified.  
• Participants were highly educated and may not be reflective of the range of newly diagnosed patients .
• A high proportion of those in the control group had genetic counseling and DNA testing, so the control group was not that different in terms of care provided.

Findings did not show that offering rapid genetic counseling and testing had any effect on QOL, anxiety, or depression among individuals newly diagnosed with breast cancer.