TY - JOUR
T1 - The FamilyTalk randomized controlled trial
T2 - patient-reported outcomes in clinical genetic sequencing for colorectal cancer
AU - Makhnoon, Sukh
AU - Bowen, Deborah J.
AU - Shirts, Brian H.
AU - Fullerton, Stephanie M.
AU - Larson, Eric B.
AU - Ralston, James D.
AU - Leppig, Kathleen A.
AU - Crosslin, David R.
AU - Veenstra, David
AU - Jarvik, Gail P.
N1 - Funding Information:
This work was supported in part by the National Human Genome Research Institute (3U01HG008657-02S1). SM was supported by a Cancer Prevention Fellowship funded by the Cancer Prevention and Research Institute of Texas (CPRIT) grant award, RP170259.
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature.
PY - 2021/5
Y1 - 2021/5
N2 - As genetics gains favor in clinical oncology, it is important to address patient concerns around confidentiality, privacy, and security of genetic information that might otherwise limit its utilization. We designed a randomized controlled trial to assess the social impact of an online educational tool (FamilyTalk) to increase family communication about colorectal cancer (CRC) risk and screening. Of 208 randomized participants, 149 (71.6%) returned six-month surveys. Overall, there was no difference in CRC screening between the study arms. Privacy and confidentiality concerns about medical and genetic information, reactions to genetic test results, and lifestyle changes did not differ between arms. Participants with pathogenic or likely pathogenic (P/LP) and variant of uncertain significance (VUS) results were more likely than those with negative results to report that the results accurately predicted their disease risks (OR 5.37, p = 0.02 and OR 3.13, p = 0.02, respectively). This trial demonstrated no evidence that FamilyTalk impacted patient-reported outcomes. Low power, due to the limited number of participants with P/LP results in the overall sample, as well as the short follow-up period, could have contributed to the null findings.
AB - As genetics gains favor in clinical oncology, it is important to address patient concerns around confidentiality, privacy, and security of genetic information that might otherwise limit its utilization. We designed a randomized controlled trial to assess the social impact of an online educational tool (FamilyTalk) to increase family communication about colorectal cancer (CRC) risk and screening. Of 208 randomized participants, 149 (71.6%) returned six-month surveys. Overall, there was no difference in CRC screening between the study arms. Privacy and confidentiality concerns about medical and genetic information, reactions to genetic test results, and lifestyle changes did not differ between arms. Participants with pathogenic or likely pathogenic (P/LP) and variant of uncertain significance (VUS) results were more likely than those with negative results to report that the results accurately predicted their disease risks (OR 5.37, p = 0.02 and OR 3.13, p = 0.02, respectively). This trial demonstrated no evidence that FamilyTalk impacted patient-reported outcomes. Low power, due to the limited number of participants with P/LP results in the overall sample, as well as the short follow-up period, could have contributed to the null findings.
KW - Colorectal cancer
KW - Confidentiality
KW - Electronic medical record
KW - Genetic testing
KW - Privacy
KW - Randomized controlled trial
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U2 - 10.1007/s10552-021-01398-1
DO - 10.1007/s10552-021-01398-1
M3 - Article
C2 - 33591484
AN - SCOPUS:85100940284
SN - 0957-5243
VL - 32
SP - 483
EP - 492
JO - Cancer Causes and Control
JF - Cancer Causes and Control
IS - 5
ER -