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Randomized Controlled Trial
. 2011 May-Jun;31(3):412-21.
doi: 10.1177/0272989X10381283. Epub 2010 Sep 27.

Longitudinal changes in patient distress following interactive decision aid use among BRCA1/2 carriers: a randomized trial

Gillian W Hooker  1 , Kara-Grace Leventhal  1 , Tiffani DeMarco  1 , Beth N Peshkin  1 , Clinton Finch  1 , Erica Wahl  2 , Jessica Rispoli Joines  3 , Karen Brown  4 , Heiddis Valdimarsdottir  5 , Marc D Schwartz  1
Affiliations
Randomized Controlled Trial

Longitudinal changes in patient distress following interactive decision aid use among BRCA1/2 carriers: a randomized trial

Gillian W Hooker et al. Med Decis Making. 2011 May-Jun.

Abstract

Background: Increasingly, women with a strong family history of breast cancer are seeking genetic testing as a starting point to making significant decisions regarding management of their cancer risks. Individuals who are found to be carriers of a BRCA1 or BRCA2 mutation have a substantially elevated risk for breast cancer and are frequently faced with the decision of whether to undergo risk-reducing mastectomy.

Objective: In order to provide BRCA1/2 carriers with ongoing decision support for breast cancer risk management, a computer-based interactive decision aid was developed and tested against usual care in a randomized controlled trial.

Design: . Following genetic counseling, 214 female (aged 21-75 years) BRCA1/2 mutation carriers were randomized to usual care (UC; n = 114) or usual care plus decision aid (DA; n = 100) arms. UC participants received no further intervention; DA participants were sent the CD-ROM-based decision aid to view at home.

Main outcome measures: The authors measured general distress, cancer-specific distress, and genetic testing-specific distress at 1-, 6-, and 12-month follow-up time points postrandomization.

Results: Longitudinal analyses revealed a significant longitudinal impact of the DA on cancer-specific distress (B = 5.67, z = 2.81, P = 0.005), which varied over time (DA group by time; B = -2.19, z = -2.47, P = 0.01), and on genetic testing-specific distress (B = 5.55, z = 2.46, P = 0.01), which also varied over time (DA group by time; B = -2.46, z = -2.51, P = 0.01). Individuals randomized to UC reported significantly decreased distress in the month following randomization, whereas individuals randomized to the DA maintained their postdisclosure distress over the short term. By 12 months, the overall decrease in distress between the 2 groups was similar.

Conclusion: This report provides new insight into the long-term longitudinal effects of DAs.

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Conflict of interest statement

The authors do not have any financial conflicts to disclose.

Figures

Figure 1
Figure 1. Study Flow Chart
Figure 2
Figure 2. Mean Distress Levels by Randomization Group
See this image and copyright information in PMC

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