Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers: Impact on measures of decision making and satisfaction.

Abstract

Objective Genetic testing is increasingly part of routine clinical care for women with a family history of breast cancer. Given their substantially elevated risk for breast cancer, BRCA1/BRCA2 mutation carriers must make the difficult decision whether or not to opt for risk reducing mastectomy. To help BRCA1/2 carriers make this decision, we developed a computer-based interactive decision aid which we tested against usual care in a randomized controlled trial. Design Following the completion of genetic counseling, 214 female (aged 21–75) BRCA1/BRCA2 mutation carriers were randomized to Usual Care (UC; N=114) or Usual Care plus Decision Aid (DA; N=100) arms. UC participants received no additional intervention. DA participants were sent the CD-ROM decision aid to view at home. Main Outcome Measures We measured final management decision, decisional conflict, decisional satisfaction and receipt of risk reducing mastectomy at 1-, 6-, and 12-months post-randomization. Results Longitudinal analyses revealed that the DA was effective among carriers who were initially undecided about how to manage their breast cancer risk. Within this group, the DA led to an increased likelihood of reaching a management decision (OR=3.09, 95% CI=1.62, 5.90; p<.001), decreased decisional conflict (B=−.46, z=−3.1, p<.002), and increased satisfaction (B=.27, z=3.1, p=0.002) compared to UC. Among carriers who had already made a management decision by the time of randomization, the DA had no benefit relative to UC. Conclusion These results demonstrate that BRCA1/BRCA2 mutation carriers who are having difficulty making a breast cancer risk management decision can benefit from adjunct decision support.

Sharing vs. caring—The relative impact of sharing decisions versus managing emotions on patient outcomes

“…Previous studies have found that interventions designed to facilitate SDM (such as decision aids) reduce decisional conflict [e.g. 29], although a recent review concluded that evidence of effectiveness is mixed [30]. In contrast, blocking behaviour, such as interrupting and monopolising, was associated with increased 16 decisional conflict.…”

Decision Aids for Patients Facing a Surgical Treatment Decision

“…In 6 studies, decision aids were sent to patients by mail. 20,23,26,[28][29][30] Patients in the control groups had received either care as usual or general patient education materials.…”

BRCA carriers' thoughts on risk management in relation to preimplantation genetic diagnosis and childbearing: when too many choices are just as difficult as none

“…Although focus group participants did not indicate specific types of information they were interested in receiving about fertility, they believed it should be given by health care providers using a systematic approach. To our knowledge there are several websites and decision aids about genetic testing (8,9), assisted reproductive technology (10), and cancer risk for survivors (11,12), but none are designed specifically for preimplantation genetic diagnosis and fertility preservation for patients at risk for development of cancer (13).…”