Breast Cancer Research and Treatment

, Volume 107, Issue 2, pp 289–301 | Cite as

A randomized controlled trial of a decision aid for women considering genetic testing for breast and ovarian cancer risk

  • Claire E. Wakefield
  • Bettina Meiser
  • Judi Homewood
  • Michelle Peate
  • Alan Taylor
  • Elizabeth Lobb
  • Judy Kirk
  • Mary-Anne Young
  • Rachel Williams
  • Tracy Dudding
  • Kathy Tucker
  • the AGenDA Collaborative Group
Preclinical Study/Clinical Trial/Epidemiology/Invited Commentary



To measure the effectiveness of a tailored decision aid (DA) designed to help women make informed decisions about genetic testing for breast/ovarian cancer risk.


A total of 145 women were randomized to receive the DA or a control pamphlet at the end of their first genetic counseling consultation. Of these, 120 (82.8%) completed two questionnaires, 1 week and 6 months post-consultation.


While the DA had no effect on informed choice, post-decisional regret or actual genetic testing decision, the trial showed that women who received the DA had higher knowledge levels and felt more informed about genetic testing than women who received the control pamphlet (χ2(2) = 6.82; P = 0.033; χ2(1) = 4.86; P = 0.028 respectively). The DA also helped women who did not have blood drawn at their first consultation to clarify their values with regards to genetic testing (χ2(1) = 5.27; P = 0.022). Women who received the DA were less likely to share the information with other family members than women in the control condition (χ2(1) = 8.78; P = 0.003).


Decision aids are an effective decision-support strategy for women considering genetic testing for breast/ovarian cancer risk, and are most effective before the patient has made a decision, which is generally at the point of having blood drawn.


Decision aid Patient education Genetic testing Hereditary breast cancer Hereditary ovarian cancer 


  1. 1.
    International Breast Cancer Intervention Study Investigators (2002) First results from the International Breast Cancer Intervention Study (IBIS-I): a randomised prevention trial. Lancet 360:817–824Google Scholar
  2. 2.
    Hartmann LC, Schaid DJ, Woods JE et al (1999) Efficacy of bilateral prophylactic mastectomy in women with a family history of breast cancer. N Engl J Med 340:77–84PubMedCrossRefGoogle Scholar
  3. 3.
    Scheuer L, Kauff N, Robson M et al (2002) Outcome and preventive surgery and screening for breast and ovarian cancer in BRCA mutation carriers. J Clin Oncol 20:1260–1268PubMedCrossRefGoogle Scholar
  4. 4.
    Meijers-Heijboer H, Van Geel B, Van Putten W et al (2001) Breast cancer after prophylactic mastectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med 345:159–164PubMedCrossRefGoogle Scholar
  5. 5.
    Levy-Lahad E, Friedman E (2007) Cancer risks among BRCA1 and BRCA2 mutation carriers. BJC 96:11–15PubMedGoogle Scholar
  6. 6.
    Lodder LN, Frets PG, Trijsburg RW et al (2002) One year follow-up of women opting for presymptomatic testing for BRCA1 and BRCA2: emotional impact of the test outcome and decisions on risk management (surveillance or prophylactic surgery). Breast Cancer Res Treat 73:97–112PubMedCrossRefGoogle Scholar
  7. 7.
    Ford D, Easton DF, Stratton M et al (1998) Genetic heterogeneity and penetrance analysis of the BRCA1 and BRCA2 genes in breast cancer families. Am J Hum Genet 62:676–689PubMedCrossRefGoogle Scholar
  8. 8.
    National Health and Medical Research Council (1999) Familial aspects of cancer: A guide to clinical practice. National Health and Medical Research Council, Canberra, November 1999Google Scholar
  9. 9.
    Meiser B (2005) Psychological impact of genetic testing for cancer susceptibility: an update of the literature. Psychooncology 14:1060–1074PubMedCrossRefGoogle Scholar
  10. 10.
    van Dijk S, Otten W, Timmermans DR et al (2005) What’s the message? Interpretation of an uninformative BRCA1/2 test result for women at risk of familial breast cancer. Genet Med 7:239–245PubMedCrossRefGoogle Scholar
  11. 11.
    van Dijk S, Timmermans DRM, Meijers-Heijboer H et al (2006) Clinical characteristics affect the impact of an uninformative DNA test result: the course of worry and distress experienced by women who apply for genetic testing for breast cancer. J Clin Oncol 24:3672–3677PubMedCrossRefGoogle Scholar
  12. 12.
    Ropka M, Wenzel J, Phillips E et al (2006) Uptake rates for breast cancer genetic testing: a systematic review. Cancer Epidemiol Biomarkers Prev 15:840–855PubMedCrossRefGoogle Scholar
  13. 13.
    O’Connor AM, Mulley AG Jr, Wennberg JE (2003) Standard consultations are not enough to ensure decision quality regarding preference-sensitive options. J Natl Cancer Inst 95:570–571PubMedCrossRefGoogle Scholar
  14. 14.
    O’Connor AM, Rostom A, Fiset V et al (1999) Decision aids for patients facing health treatment or screening decisions: systematic review. BMJ 319:731–734PubMedGoogle Scholar
  15. 15.
    O’Connor A, Tugwell P, Welles GA et al (1998) Randomized trial of a portable, self-administered decision aid for postmenopausal women considering long-term preventative hormone replacement therapy. Med Decis Making 18:295–303PubMedCrossRefGoogle Scholar
  16. 16.
    O’Connor AM (1999) Decision aids for patients considering options affecting cancer outcomes: evidence of efficacy and policy implications. J Natl Cancer Inst 25:67–80Google Scholar
  17. 17.
    Elwyn G, O’Connor A, Stacey D et al (2006) Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ 333:417PubMedCrossRefGoogle Scholar
  18. 18.
    Wakefield CE, Meiser B, Homewood J et al (in press) Development and pilot testing of two decision aids for individuals considering genetic testing for cancer risk. J Genet CounsGoogle Scholar
  19. 19.
    Australian Cancer Network (1999) Guidelines on familial aspects of cancer. Australian Cancer Network, Sydney, November 1999Google Scholar
  20. 20.
    National Breast Cancer Centre (2000) Current best advice about familial aspects of breast/ovarian cancer. NHMRC National Breast Cancer Centre, Sydney, 2000Google Scholar
  21. 21.
    Centre for Genetics Education (2007) Centre for Genetics Education. Cited 19 Jan 2007Google Scholar
  22. 22.
    O’Connor AM, Stacey D, Entwistle V et al (2006) Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 1:1Google Scholar
  23. 23.
    Rimer BK, Glassman B (1999) Is there a use for tailored print communications in cancer risk communication? J Natl Cancer Inst 25:140–148Google Scholar
  24. 24.
    Bastani R, Maxwell A, Bradford C et al (1999) Tailored risk notification for women with a family history of breast cancer. Prev Med 29:355–364PubMedCrossRefGoogle Scholar
  25. 25.
    O’Connor AM (1995) Validation of a decisional conflict scale. Med Decis Making 15:25–30PubMedCrossRefGoogle Scholar
  26. 26.
    Michie S, Dormandy E, Marteau TM (2002) The multi-dimensional measure of informed choice: a validation study. Patient Educ Couns 48:87–91PubMedCrossRefGoogle Scholar
  27. 27.
    Horowitz MJ, Wilner N, Alvarez W (1979) Impact of event scale: a measure of subjective stress. Psychosom Med 41:209–218PubMedGoogle Scholar
  28. 28.
    Thewes B, Meiser B, Hickie IB et al (2001) Psychometric properties of the impact of event scale amongst women at increased risk for hereditary breast cancer. Psychooncology 10:459–468PubMedCrossRefGoogle Scholar
  29. 29.
    Zigmond A, Snaith R (1983) The hospital anxiety and depression scale. Psychiatr Scand 67:361CrossRefGoogle Scholar
  30. 30.
    Hall A, A’Hern R, Fallowfield L (1999) Are we using appropriate self-report questionnaires for detecting anxiety and depression in women with early breast cancer? Eur J Cancer 35:79–85PubMedCrossRefGoogle Scholar
  31. 31.
    Johnston M, Pollard B, Hennessey P (2000) Construct validation of the hospital anxiety and depression scale with clinical populations. J Psychosom Res 48:579–584PubMedCrossRefGoogle Scholar
  32. 32.
    Ibbotson T, Maguire P, Selby P et al (1994) Screening for anxiety and depression in cancer patients: the effects of disease and treatment. Eur J Cancer 30A:37–40PubMedCrossRefGoogle Scholar
  33. 33.
    Brehaut JC, O’Connor AM, Wood TJ et al (2003) Validation of a decision regret scale. Med Decis Making 23:281–292PubMedCrossRefGoogle Scholar
  34. 34.
    SPSS Inc. (2005) Statistical Program for the Social Sciences: Release 14.0. SPSS Inc., Chicago, ILGoogle Scholar
  35. 35.
    StataCorp (2005) Stata Statistical software: Release 9.0. StataCorp, College Station, TXGoogle Scholar
  36. 36.
    Williams RL (2000) A note on robust variance estimation for cluster-correlated data. Biometrics 56:645–646PubMedCrossRefGoogle Scholar
  37. 37.
    Bekker HL, Legare F, Stacey D et al (2003) Is anxiety a suitable measure of decision aid effectiveness: a systematic review? Patient Educ Couns 50:255–262PubMedCrossRefGoogle Scholar
  38. 38.
    Botkin JR, Smith KR, Croyle RT et al (2003) Genetic testing for a BRCA1 mutation: prophylactic surgery and screening behavior in women 2 years post testing. Am J Med Genet A 118:201–209PubMedCrossRefGoogle Scholar
  39. 39.
    Cull A, Anderson EDC, Campbell S et al (1999) The impact of genetic counselling about breast cancer risk on women’s risk perceptions and levels of distress. BJC 79:501–508PubMedGoogle Scholar
  40. 40.
    Lerman C, Narod S, Schulman K et al (1996) BRCA1 testing in families with hereditary breast-ovarian cancer. JAMA 275:1885–1892PubMedCrossRefGoogle Scholar
  41. 41.
    Meijers-Heijboer EJ, Verhoog LC, Brekelmans CT et al (2000) Presymptomatic DNA testing and prophylactic surgery in families with a BRCA1 or BRCA2 mutation. Lancet 335:2015–2020CrossRefGoogle Scholar
  42. 42.
    O’Neill SM, Peters JA, Vogel VG et al (2006) Referral to cancer genetic counseling: are there stages of readiness? Am J Med Genet C 142:221–231Google Scholar
  43. 43.
    Mancini J, Nogues C, Adenis C et al (2006) Impact of an information booklet on satisfaction and decision-making about BRCA genetic testing. Eur J Cancer 42:871–881PubMedCrossRefGoogle Scholar
  44. 44.
    Mireskandari S, Meiser B, Sherman K et al (2006) Evaluation of the needs and concerns of partners of women at high risk of developing breast/ovarian cancer. Psychooncology 15:96–108PubMedCrossRefGoogle Scholar
  45. 45.
    Manne S, Audrain J, Schwartz M et al (2004) Associations between relationship support and psychological reactions of participants and partners to BRCA1 and BRCA2 testing in a clinic-based sample. Ann Behav Med 28:211–225PubMedCrossRefGoogle Scholar
  46. 46.
    Schwartz MD, Lerman C, Brogan B et al (2005) Utilization of BRCA1/BRCA2 mutation testing in newly diagnosed breast cancer patients. Cancer Epidemiol Biomarkers Prev 14:1003–1007PubMedCrossRefGoogle Scholar
  47. 47.
    Australian Bureau of Statistics (2006) Australian social trends 2006. Australian Bureau of Statistics, CanberraGoogle Scholar
  48. 48.
    Meiser B, Butow P, Friedlander M et al (2002) Psychological impact of genetic testing for women for breast cancer susceptibility. Eur J Cancer 38:2025–2033PubMedGoogle Scholar
  49. 49.
    Tiller K, Meiser B, Gaff C et al (2006) A randomized controlled trial of a decision aid for women at increased risk of ovarian cancer. Med Decis Making 26:360–372PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Claire E. Wakefield
    • 1
    • 2
    • 3
  • Bettina Meiser
    • 2
    • 3
  • Judi Homewood
    • 1
  • Michelle Peate
    • 2
  • Alan Taylor
    • 1
  • Elizabeth Lobb
    • 4
    • 5
  • Judy Kirk
    • 6
  • Mary-Anne Young
    • 7
  • Rachel Williams
    • 8
  • Tracy Dudding
    • 9
  • Kathy Tucker
    • 2
    • 10
  • the AGenDA Collaborative Group
  1. 1.Department of PsychologyMacquarie UniversitySydneyAustralia
  2. 2.Psychosocial Research Group (PRG), Department of Medical OncologyPrince of Wales HospitalRandwick, SydneyAustralia
  3. 3.School of PsychiatryUniversity of New South WalesRandwick, SydneyAustralia
  4. 4.WA Centre for Cancer & Palliative Care, School of Nursing, Midwifery and Postgraduate MedicineEdith Cowan UniversityPerthAustralia
  5. 5.Medical Psychology Research UnitThe University of SydneyCamperdownAustralia
  6. 6.Familial Cancer ServiceWestmead HospitalWestmeadAustralia
  7. 7.Familial Cancer CentrePeter MacCallum Cancer CentreMelbourneAustralia
  8. 8.Family Cancer ClinicSt Vincent’s HospitalDarlinghurst, SydneyAustralia
  9. 9.Hunter Family Cancer ServiceHunter New England HealthNewcastleAustralia
  10. 10.Prince of Wales Clinical SchoolUniversity of NSWRandwick, SydneyAustralia

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