Purpose. To carry out a randomized controlled trial of a decision aid for women at increased risk of developing ovarian cancer to facilitate decision making regarding risk management options. Methods. This randomized trial, conducted through 6 familial cancer centers, compared the efficacy of tailored decision aid to that of a general educational pamphlet in preparing women for decision making. Participants. 131 women with a family history of breast and/or ovarian cancer or of hereditary nonpolyposis colorectal cancer. Outcome measures. Decisional conflict, knowledge about ovarian cancer risk management options, and psychological adjustment were reassessed at 3 time points. Results. Compared to those who received the pamphlet (control), women who received the decision aid (intervention) were significantly more likely to report a high degree of acceptability of the educational material at both follow-up assessment time points. Findings indicate neither group experienced significant increases in psychological distress at either follow-up assessment time points relative to baseline. Two weeks postintervention, the intervention group demonstrated a significant decrease in decisional conflict compared to the control group (t = 2.4, P < 0.025) and a trend for a greater increase in knowledge about risk management options (t = 2.1, P = 0.037). No significant differences were found 6 months postintervention. Conclusion. This form of educational material is successful in increasing knowledge about risk management options and in reducing decisional conflict in the shorter term. The decision aid is an effective and acceptable strategy for patient education to facilitate an inclusive and informed decision-making process about managing ovarian cancer risk.
Schildkraut JM, Thompson WD. Familial ovarian cancer: a population-based case-control study. Am J Epidemiol. 1988;128: 456–466.
2.
Fishman D, Cohen L. Is transvaginal ultrasound effective for screening asymptomatic women for the detection of early-stage epithelial ovarian cancer?Gynecol Oncol. 2000;77:347–349.
3.
Burke W, Daly M, Garber J, et al. Recommendations for follow-up care of individuals with an inherited predisposition to cancer. II. BRCA1 and BRCA2. JAMA. 1997;277(12):997–1003.
4.
National Health and Medical Research Council of Australia. Familial Aspects of Cancer: A Guide to Clinical Practice. Clinical Practice Guidelines. Canberra: Australian Cancer Network; 1999.
5.
Kauff N, Satagopan J, Robson M, et al. Risk-reducing salpingooophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med. 2002;346(21):1609–1615.
6.
Rebbeck T, Lynch H, Neuhausen S, et al. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med. 2002;346(21):1616–1622.
7.
Vasen HF. Current policies for surveillance and management in women at risk of breast and ovarian cancer: a survey among 16 European family cancer clinics. Eur J Cancer. 1998;34(12):1922–1926.
8.
Anthill Y, Phillips KA. Screening for ovarian cancer high risk. In: Gershenson D, McGuire WP, Gore M, Quinn MA, Thomas G, eds. Gynecologic Cancer: Controversies in Management. Philadelphia: Elsevier; 2004. pp. 341-354.
9.
Edwards A, Elwyn G. The potential benefits of decision aids in clinical medicine. JAMA. 1999;282(8):779–780.
10.
Frosch D, Kaplan R. Shared decision making in clinical medicine: past research and future directions. Am J Prev Med. 1999; 17(4):285–294.
11.
O'Connor A. Decision aids for patients considering options affecting cancer outcomes: evidence of efficacy and policy implications. J Natl Cancer Inst. 1999;25:67–80.
12.
Ubel P. Is information always a good thing? Helping patients make ‘good’ decisions. Med Care. 2002;40(9 Suppl):V39–V44.
13.
O'Connor A, Rostom A, Fiset V, et al. Decision aids for patients facing health treatment or screening decisions: systematic review. BMJ. 1999:731–734.
14.
O'Connor A, Rostom A, Fiset V, et al. Decision aids for people facing health treatment or screening decisions (Cochrane review). Cochrane Database of Systematic Reviews. (3):CD001431-CD0014312001(3).
15.
Tiller K, Meiser B, Reeson E, et al. A decision aid for women at increased risk for ovarian cancer. Int J Gynecol Cancer. 2003;13:1–8.
16.
National Health and Medical Research Council. How to Present Evidence for Consumers: Preparation of Consumer Publications. Canberra, Australia: National Health and Medical Research Council; 1999.
17.
O'Connor A. Evaluation standards for patient decision supports. Med Decis Making. 1995;15(1):2–3.
18.
O'Connor AM, Tugwell P, Wells GA, et al. A decision aid for women considering hormone therapy after menopause: decision support framework and evaluation. Pat Educ Counsel. 1998;33:267–279.
19.
O'Connor A, Tugwell P, Welles GA, et al. Randomized trial of a portable, self-administered decision aid for postmenopausal women considering long-term preventative hormone replacement therapy. Med Decis Making. 1998;18:295–303.
20.
O'Connor A, Pennie RA, Dales RE. Framing effects on expectations, decisions and side-effects experienced: the case of influenza immunization. J Clin Epidemiol. 1996;49(11):1271–1276.
21.
O'Connor A, Tugwell P, Welles GA, et al. Guiding the Development of Decision Aids for Patients and Practitioners Considering Health Care Interventions. Ottawa: Ottawa Health Research Institute; 2001. Available from: www.ohri.ca.
22.
Tiller K, Meiser B, Reeson L, et al. Knowledge of risk management strategies, and information and risk management preferences of women at increased risk for ovarian cancer. Psycho-Oncol. 2004;13:1–13.
23.
Meiser B, Tiller K, Gleeson M, Andrews L, Robertson G, Tucker K. Psychological impact of prophylactic oophorectomy in women at risk for hereditary ovarian cancer. Psycho-Oncol. 2000;9:496–503.
24.
Horowitz MJ, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979;41:209–218.
25.
Meiser B, Butow P, Barratt A, et al. Attitudes to prophylactic oophorectomy and screening utilization in women at increased risk of developing hereditary breast/ovarian cancer. Gynecol Oncol. 1999;75:122–129.
26.
Thewes B, Meiser B, Hickie I. Validation of the Impact of Events Scale in women at increased risk of developing hereditary breast cancer. Psycho-Oncol. 2001;10(6):459–468.
27.
Meiser B, Butow P, Barratt A, et al. Attitudes to prophylactic mastectomy in women at increased risk of developing hereditary breast cancer. J Clin Oncol. 2000;18(11):2250–2257.
28.
Lerman C, Schwartz MD, Lin TH, et al. The influence of psychological distress on use of genetic testing for cancer risk. J Consult Clin Psychol. 1997;65(3):414–420.
29.
Spielberger CD. Manual for the State-Trait Anxiety Inventory for Adults (Form Y). Palo Alto (CA): Mind Garden; 1983.
30.
Marteau TM, Bekker H. The development of a six-item shortform of the State scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992;31:301–306.
31.
Zigmond A, Snaith R. The hospital anxiety and depression scale. Psychiatr Scand. 1983;67:361-361.
32.
Hopwood P, Howell A, Maguire P. Screening for psychiatric disorder in patients with advanced breast cancer: validation of two self-report questionnaires. Br J Cancer. 1991;64:353–356.
33.
Bjelland I, Dahl A, Haug T, Neckelmann D. The validity of the Hospital and Anxiety Depression Scale. J Psychosom Res. 2002; 52(2):69–77.
34.
Ibbotson T, Maguire P, Selby P, Priestman T, Wallace L. Screening for anxiety and depression in cancer patients: the effects of disease and treatment. Eur J Cancer. 1994;30A(1):37–40.
35.
Barry M. Health decision aids to facilitate shared decision making in office practice. Ann Intern Med. 2002;136:127–135.
36.
O'Connor A. Validation of a decisional conflict scale. Med Decis Making. 1995;15:25–30.
37.
Bunn H, O'Connor A. Validation of client decision-making instruments in the context of psychiatry. Can J Nurs Res. 1996;28(3):13–27.
38.
Drake E, Engler-Todd L, O'Connor A, Surh L, Hunter A. Development and evaluation of a decision aid about prenatal testing for women of advanced maternal age. J Genet Counsel. 1999;8(4):217–233.
39.
Rothert M, Holmes-Rovner M, Rovner D, et al. An educational intervention as decision support for menopausal women. Res Nurs Health. 1997;377–387.
40.
Goldstein H. Multilevel Statistical Models. New York: Halstead; 1995.
41.
Mills M, Sullivan K. The importance of information giving for patients newly diagnosed with cancer: a review of the literature. J Clin Nurs. 1999;8:631–642.
42.
Jefford M, Tattersall M. Informing and involving cancer patients in their own care. Lancet Oncol. 2002;3:629–637.
43.
Molenaar S, Mirjam A, Sprangers G, et al. Feasibility and effects of decision aids. Med Decis Making. 2000(20):112–127.
44.
Whelan T, Gafni A, Charles C, Levine M. Lessons learned from the decision board: a unique and evolving decision aid. Health Expect. 2000;3(1):69–79.
45.
Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997;44(5):681–692.
46.
Fischhoff B. What do patients want? Help in making effective choices. Effect Clin Pract. 1999;2(4):198–200.
47.
Fisher R, Fisher E. What is a good decision?Effect Clin Pract. 1999;2(4):189–190.
48.
Pauker SG, Pauker SP. What is a good decision?Effect Clin Pract. 1999;2(4):194–196.
49.
Rimer B. What is a good decision?Effect Clin Pract. 1999; 2(4):193–194.
50.
Sox HC. What is a good decision?Effect Clin Pract. 1999;2(4): 196–197.
51.
Miller SM, Rodoletz M, Schroeder CM, Mangan CE, Sedlacek TV. Applications of the monitoring process model to coping with severe long-term medical threats. Health Psychol. 1996;15(3): 216–225.
52.
Miller SM, Fang CY, Manne SL, Engstrom PF, Daly MB. Decision making about prophylactic oophorectomy among at-risk women: Psychological influences and implications. Gynecol Oncol. 1999;75:406–412.
53.
Leydon G, Boulton M, Moynihan C, et al. Cancer patients' information needs and information seeking behaviour: in depth interview study. BMJ. 2000;320(7239):909–913.
54.
Fallowfield LJ, Baum M, Maguire GP. Effects of breast conservation on psychological morbidity associated with diagnosis and treatment of early breast cancer. BMJ. 1986;293:1331–1334.
55.
Fallowfield LJ, Hall A, Maguire GP, Baum M. Psychological outcomes of different treatment policies in women with early breast cancer outside a clinical trial. BMJ. 1990;301:575–580.
56.
Fallowfield L, Ford S, Lewis S. No news is not good news: Information preferences of patients with cancer. Psycho-Oncol. 1995;4:197–202.
57.
Lodder LN, Frets P, Trijsburg R, et al. Psychological impact of receiving a BRCA1/BRCA2 test result. Am J Med Genet. 2001;98:15–24.
58.
Watson M, Foster C, Evans G. Predictive genetic testing: psychosocial impact of the new genetic technology. Presented at the International Meeting on Psychosocial Aspects of Genetic Testing for Hereditary Breast and/or Ovarian Cancer (HBOC) and Hereditary Non-Polyposis Colorectal Cancer (HNPCC), 2001, Frankfurt.
59.
Meiser B, Butow P, Friedlander M, et al. Psychological impact of genetic testing for women for breast cancer susceptibility. Eur J Cancer. 2002;38(15):2025–2033.
60.
Davison B, Kirk P, Degner L, Hassard T. Information and patient participation in screening for prostate cancer. Pat Educ Counsel. 1999;37:255–263.
61.
Meiser B, Butow P, Barratt A, et al. Risk perceptions and knowledge of breast cancer genetics in women at increased risk of developing hereditary breast cancer. Psychol Health. 2001;5(4): 377–388.
62.
Cull A, Anderson EDC, Campbell S, Mackay J, Smyth E, Steel M. The impact of genetic counselling about breast cancer risk on women's risk perceptions and levels of distress. Br J Cancer. 1999;79(3/4):501–508.
