Streamlined genetic education is effective in preparing women newly diagnosed with breast cancer for decision making about treatment-focused genetic testing: A randomized controlled noninferiority trial

Veronica F. Quinn, Bettina Meiser, Judy Kirk, Kathy M. Tucker, Kaaren J. Watts, Belinda Rahman, Michelle Peate, Christobel Saunders, Elizabeth Geelhoed, Margaret Gleeson, Kristine Barlow-Stewart, Michael Field, Marion Harris, Yoland C. Antill, Linda Cicciarelli, Karen Crowe, Michael T. Bowen, Gillian Mitchell, P. Gregory, L. Lipton & 43 others L. McKay, J. Senior, L. Lobb, P. Crowe, A. Matthews, G. Neil, A. Parasyn, D. Thomson, J. Duffy, L. Andrews, J. Gale, J. Fox, S. Hart, C. Smythe, M. White, L. Creighton, J. D'arcy, S. Grieve, E. Secomb, M. Henderson, J. O'Brien, C. Poliness, A. Hattam, R. Susman, O. Ung, R. DIckson, K. Moore, P. Bastick, S. Inder, J. Lynch, P. Schwartz, R. Zia, C. Mak, K. Snook, A. Spillane, J. Hopper, M. Bowman, D. Cheung, S. Edirimanne, E. Edwards, E. Elder, J. French, D. Moon

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Purpose: Increasingly, women newly diagnosed with breast cancer are being offered treatment-focused genetic testing (TFGT). As the demand for TFGT increases, streamlined methods of genetic education are needed. Methods: In this noninferiority trial, women aged <50 years with either a strong family history (FH+) or other features suggestive of a germ-line mutation (FH-) were randomized before definitive breast cancer surgery to receive TFGT education either as brief written materials (intervention group (IG)) or during a genetic counseling session at a familial cancer clinic (usual-care group (UCG)). Women completed self-report questionnaires at four time points over 12 months. Results: A total of 135 women were included in the analysis, all of whom opted for TFGT. Decisional conflict about TFGT choice (primary outcome) was not inferior in the IG compared with the UCG (noninferiority margin of -10; mean difference = 2.45; 95% confidence interval -2.87-7.76; P = 0.36). Costs per woman counseled in the IG were significantly lower (AUD$89) compared with the UCG (AUD$173; t(115) = 6.02; P < 0.001). Conclusion: A streamlined model of educating women newly diagnosed with breast cancer about TFGT seems to be a cost-effective way of delivering education while ensuring that women feel informed and supported in their decision making, thus freeing resources for other women to access TFGT.

Original languageEnglish
Pages (from-to)448-456
Number of pages9
JournalGenetics in Medicine
Volume19
Issue number4
DOIs
Publication statusPublished - 1 Apr 2017

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Genetic Testing
Decision Making
Randomized Controlled Trials
Breast Neoplasms
Education
Therapeutics
Costs and Cost Analysis
Germ-Line Mutation
Genetic Counseling
Self Report
Confidence Intervals

Cite this

Quinn, Veronica F. ; Meiser, Bettina ; Kirk, Judy ; Tucker, Kathy M. ; Watts, Kaaren J. ; Rahman, Belinda ; Peate, Michelle ; Saunders, Christobel ; Geelhoed, Elizabeth ; Gleeson, Margaret ; Barlow-Stewart, Kristine ; Field, Michael ; Harris, Marion ; Antill, Yoland C. ; Cicciarelli, Linda ; Crowe, Karen ; Bowen, Michael T. ; Mitchell, Gillian ; Gregory, P. ; Lipton, L. ; McKay, L. ; Senior, J. ; Lobb, L. ; Crowe, P. ; Matthews, A. ; Neil, G. ; Parasyn, A. ; Thomson, D. ; Duffy, J. ; Andrews, L. ; Gale, J. ; Fox, J. ; Hart, S. ; Smythe, C. ; White, M. ; Creighton, L. ; D'arcy, J. ; Grieve, S. ; Secomb, E. ; Henderson, M. ; O'Brien, J. ; Poliness, C. ; Hattam, A. ; Susman, R. ; Ung, O. ; DIckson, R. ; Moore, K. ; Bastick, P. ; Inder, S. ; Lynch, J. ; Schwartz, P. ; Zia, R. ; Mak, C. ; Snook, K. ; Spillane, A. ; Hopper, J. ; Bowman, M. ; Cheung, D. ; Edirimanne, S. ; Edwards, E. ; Elder, E. ; French, J. ; Moon, D. / Streamlined genetic education is effective in preparing women newly diagnosed with breast cancer for decision making about treatment-focused genetic testing : A randomized controlled noninferiority trial. In: Genetics in Medicine. 2017 ; Vol. 19, No. 4. pp. 448-456.
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title = "Streamlined genetic education is effective in preparing women newly diagnosed with breast cancer for decision making about treatment-focused genetic testing: A randomized controlled noninferiority trial",
abstract = "Purpose: Increasingly, women newly diagnosed with breast cancer are being offered treatment-focused genetic testing (TFGT). As the demand for TFGT increases, streamlined methods of genetic education are needed. Methods: In this noninferiority trial, women aged <50 years with either a strong family history (FH+) or other features suggestive of a germ-line mutation (FH-) were randomized before definitive breast cancer surgery to receive TFGT education either as brief written materials (intervention group (IG)) or during a genetic counseling session at a familial cancer clinic (usual-care group (UCG)). Women completed self-report questionnaires at four time points over 12 months. Results: A total of 135 women were included in the analysis, all of whom opted for TFGT. Decisional conflict about TFGT choice (primary outcome) was not inferior in the IG compared with the UCG (noninferiority margin of -10; mean difference = 2.45; 95{\%} confidence interval -2.87-7.76; P = 0.36). Costs per woman counseled in the IG were significantly lower (AUD$89) compared with the UCG (AUD$173; t(115) = 6.02; P < 0.001). Conclusion: A streamlined model of educating women newly diagnosed with breast cancer about TFGT seems to be a cost-effective way of delivering education while ensuring that women feel informed and supported in their decision making, thus freeing resources for other women to access TFGT.",
keywords = "BRCA1, BRCA2, genetic counseling, psychological adjustment, rapid testing",
author = "Quinn, {Veronica F.} and Bettina Meiser and Judy Kirk and Tucker, {Kathy M.} and Watts, {Kaaren J.} and Belinda Rahman and Michelle Peate and Christobel Saunders and Elizabeth Geelhoed and Margaret Gleeson and Kristine Barlow-Stewart and Michael Field and Marion Harris and Antill, {Yoland C.} and Linda Cicciarelli and Karen Crowe and Bowen, {Michael T.} and Gillian Mitchell and P. Gregory and L. Lipton and L. McKay and J. Senior and L. Lobb and P. Crowe and A. Matthews and G. Neil and A. Parasyn and D. Thomson and J. Duffy and L. Andrews and J. Gale and J. Fox and S. Hart and C. Smythe and M. White and L. Creighton and J. D'arcy and S. Grieve and E. Secomb and M. Henderson and J. O'Brien and C. Poliness and A. Hattam and R. Susman and O. Ung and R. DIckson and K. Moore and P. Bastick and S. Inder and J. Lynch and P. Schwartz and R. Zia and C. Mak and K. Snook and A. Spillane and J. Hopper and M. Bowman and D. Cheung and S. Edirimanne and E. Edwards and E. Elder and J. French and D. Moon",
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Quinn, VF, Meiser, B, Kirk, J, Tucker, KM, Watts, KJ, Rahman, B, Peate, M, Saunders, C, Geelhoed, E, Gleeson, M, Barlow-Stewart, K, Field, M, Harris, M, Antill, YC, Cicciarelli, L, Crowe, K, Bowen, MT, Mitchell, G, Gregory, P, Lipton, L, McKay, L, Senior, J, Lobb, L, Crowe, P, Matthews, A, Neil, G, Parasyn, A, Thomson, D, Duffy, J, Andrews, L, Gale, J, Fox, J, Hart, S, Smythe, C, White, M, Creighton, L, D'arcy, J, Grieve, S, Secomb, E, Henderson, M, O'Brien, J, Poliness, C, Hattam, A, Susman, R, Ung, O, DIckson, R, Moore, K, Bastick, P, Inder, S, Lynch, J, Schwartz, P, Zia, R, Mak, C, Snook, K, Spillane, A, Hopper, J, Bowman, M, Cheung, D, Edirimanne, S, Edwards, E, Elder, E, French, J & Moon, D 2017, 'Streamlined genetic education is effective in preparing women newly diagnosed with breast cancer for decision making about treatment-focused genetic testing: A randomized controlled noninferiority trial' Genetics in Medicine, vol. 19, no. 4, pp. 448-456. https://doi.org/10.1038/gim.2016.130

Streamlined genetic education is effective in preparing women newly diagnosed with breast cancer for decision making about treatment-focused genetic testing : A randomized controlled noninferiority trial. / Quinn, Veronica F.; Meiser, Bettina; Kirk, Judy; Tucker, Kathy M.; Watts, Kaaren J.; Rahman, Belinda; Peate, Michelle; Saunders, Christobel; Geelhoed, Elizabeth; Gleeson, Margaret; Barlow-Stewart, Kristine; Field, Michael; Harris, Marion; Antill, Yoland C.; Cicciarelli, Linda; Crowe, Karen; Bowen, Michael T.; Mitchell, Gillian; Gregory, P.; Lipton, L.; McKay, L.; Senior, J.; Lobb, L.; Crowe, P.; Matthews, A.; Neil, G.; Parasyn, A.; Thomson, D.; Duffy, J.; Andrews, L.; Gale, J.; Fox, J.; Hart, S.; Smythe, C.; White, M.; Creighton, L.; D'arcy, J.; Grieve, S.; Secomb, E.; Henderson, M.; O'Brien, J.; Poliness, C.; Hattam, A.; Susman, R.; Ung, O.; DIckson, R.; Moore, K.; Bastick, P.; Inder, S.; Lynch, J.; Schwartz, P.; Zia, R.; Mak, C.; Snook, K.; Spillane, A.; Hopper, J.; Bowman, M.; Cheung, D.; Edirimanne, S.; Edwards, E.; Elder, E.; French, J.; Moon, D.

In: Genetics in Medicine, Vol. 19, No. 4, 01.04.2017, p. 448-456.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Streamlined genetic education is effective in preparing women newly diagnosed with breast cancer for decision making about treatment-focused genetic testing

T2 - A randomized controlled noninferiority trial

AU - Quinn, Veronica F.

AU - Meiser, Bettina

AU - Kirk, Judy

AU - Tucker, Kathy M.

AU - Watts, Kaaren J.

AU - Rahman, Belinda

AU - Peate, Michelle

AU - Saunders, Christobel

AU - Geelhoed, Elizabeth

AU - Gleeson, Margaret

AU - Barlow-Stewart, Kristine

AU - Field, Michael

AU - Harris, Marion

AU - Antill, Yoland C.

AU - Cicciarelli, Linda

AU - Crowe, Karen

AU - Bowen, Michael T.

AU - Mitchell, Gillian

AU - Gregory, P.

AU - Lipton, L.

AU - McKay, L.

AU - Senior, J.

AU - Lobb, L.

AU - Crowe, P.

AU - Matthews, A.

AU - Neil, G.

AU - Parasyn, A.

AU - Thomson, D.

AU - Duffy, J.

AU - Andrews, L.

AU - Gale, J.

AU - Fox, J.

AU - Hart, S.

AU - Smythe, C.

AU - White, M.

AU - Creighton, L.

AU - D'arcy, J.

AU - Grieve, S.

AU - Secomb, E.

AU - Henderson, M.

AU - O'Brien, J.

AU - Poliness, C.

AU - Hattam, A.

AU - Susman, R.

AU - Ung, O.

AU - DIckson, R.

AU - Moore, K.

AU - Bastick, P.

AU - Inder, S.

AU - Lynch, J.

AU - Schwartz, P.

AU - Zia, R.

AU - Mak, C.

AU - Snook, K.

AU - Spillane, A.

AU - Hopper, J.

AU - Bowman, M.

AU - Cheung, D.

AU - Edirimanne, S.

AU - Edwards, E.

AU - Elder, E.

AU - French, J.

AU - Moon, D.

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Purpose: Increasingly, women newly diagnosed with breast cancer are being offered treatment-focused genetic testing (TFGT). As the demand for TFGT increases, streamlined methods of genetic education are needed. Methods: In this noninferiority trial, women aged <50 years with either a strong family history (FH+) or other features suggestive of a germ-line mutation (FH-) were randomized before definitive breast cancer surgery to receive TFGT education either as brief written materials (intervention group (IG)) or during a genetic counseling session at a familial cancer clinic (usual-care group (UCG)). Women completed self-report questionnaires at four time points over 12 months. Results: A total of 135 women were included in the analysis, all of whom opted for TFGT. Decisional conflict about TFGT choice (primary outcome) was not inferior in the IG compared with the UCG (noninferiority margin of -10; mean difference = 2.45; 95% confidence interval -2.87-7.76; P = 0.36). Costs per woman counseled in the IG were significantly lower (AUD$89) compared with the UCG (AUD$173; t(115) = 6.02; P < 0.001). Conclusion: A streamlined model of educating women newly diagnosed with breast cancer about TFGT seems to be a cost-effective way of delivering education while ensuring that women feel informed and supported in their decision making, thus freeing resources for other women to access TFGT.

AB - Purpose: Increasingly, women newly diagnosed with breast cancer are being offered treatment-focused genetic testing (TFGT). As the demand for TFGT increases, streamlined methods of genetic education are needed. Methods: In this noninferiority trial, women aged <50 years with either a strong family history (FH+) or other features suggestive of a germ-line mutation (FH-) were randomized before definitive breast cancer surgery to receive TFGT education either as brief written materials (intervention group (IG)) or during a genetic counseling session at a familial cancer clinic (usual-care group (UCG)). Women completed self-report questionnaires at four time points over 12 months. Results: A total of 135 women were included in the analysis, all of whom opted for TFGT. Decisional conflict about TFGT choice (primary outcome) was not inferior in the IG compared with the UCG (noninferiority margin of -10; mean difference = 2.45; 95% confidence interval -2.87-7.76; P = 0.36). Costs per woman counseled in the IG were significantly lower (AUD$89) compared with the UCG (AUD$173; t(115) = 6.02; P < 0.001). Conclusion: A streamlined model of educating women newly diagnosed with breast cancer about TFGT seems to be a cost-effective way of delivering education while ensuring that women feel informed and supported in their decision making, thus freeing resources for other women to access TFGT.

KW - BRCA1

KW - BRCA2

KW - genetic counseling

KW - psychological adjustment

KW - rapid testing

UR - http://www.scopus.com/inward/record.url?scp=85017147488&partnerID=8YFLogxK

U2 - 10.1038/gim.2016.130

DO - 10.1038/gim.2016.130

M3 - Article

VL - 19

SP - 448

EP - 456

JO - Genetics in Medicine

JF - Genetics in Medicine

SN - 1098-3600

IS - 4

ER -