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Colleen M. McBride, PhD, Lori A. Bastian, MD, Susan Halabi, PhD, Laura Fish, MPH, Isaac M. Lipkus, PhD, Hayden B. Bosworth, PhD, Barbara K. Rimer, DrPH and Ilene C. Siegler, PhD, MPH

Colleen M. McBride, Susan Halabi, Laura Fish, Isaac M. Lipkus, Barbara K. Rimer, and Ilene C. Siegler are with The Comprehensive Cancer Center, Durham, NC. Colleen M. McBride, Lori A. Bastian, Susan Halabi, Isaac M. Lipkus, Hayden B. Bosworth, Barbara K. Rimer, and Ilene C. Siegler are with Duke University Medical Center, Durham, NC. Lori A. Bastian and Hayden B. Bosworth are also with Durham Veteran's Administration Medical Center, Durham, NC. Barbara K. Rimer is also with the National Cancer Institute, Division of Cancer Control and Population Sciences, Bethesda, Md.

Correspondence: Colleen M. McBride, PhD, Duke Cancer Prevention, Detection, and Control Research, DUMC Box 2949, Durham, NC 27710-2949 (e-mail: mcbri002{at}mc.duke.edu).

	INTRODUCTION

TOP INTRODUCTION METHODS RESULTS DISCUSSION References

 
Decision aids related to hormone replacement therapy (HRT), whether delivered in written form,^1,2 along with audiotapes,³ or as part of discussion groups,⁴ have outperformed generic brochures in increasing knowledge and accuracy of risk assessments. However, these decision aids have provided women with population-based estimates of average risk, not individual risk levels that may have bearing on their decisions about HRT. Decision aids individually customized or "tailored" to include only the most relevant information could make it easier for women to consider HRT's risks and benefits.^5,6 Tailored interventions have yet to be evaluated for HRT decisions. We describe the effect of a tailored decision aid on women's accuracy of perceived risk for breast cancer, confidence to decide about HRT, and satisfaction with the decision.

	METHODS

TOP INTRODUCTION METHODS RESULTS DISCUSSION References

 
Study Design
Between October 1998 and February 1999, interviewers called households from a purchased list to identify women aged 45 to 54 years who were willing to receive written materials about HRT and who did not have a history of breast cancer. Eligible women stratified by baseline HRT use were randomized to either a delayed or an active intervention arm. Women in the active arm received materials 2 weeks after the baseline survey; those in the delayed arm received materials after completing the study. Telephone surveys were conducted at 1 and 9 months. Study protocols were approved by the institutional review board.

Intervention
The trifold decision aid⁷ included (1) "Step 1 The Facts" (19 pages), which was tailored to baseline perceived menopausal status, hysterectomy status (no or yes), prior HRT use, and accuracy of perceived risk for breast cancer⁸; (2) "Step 2 What's Important to You," a worksheet to record preferences; "Step 3 Next Steps" (13 pages), which included vignettes of women at decision points similar to those of women receiving the intervention and a checklist of questions for the health care providers of women receiving the intervention.

Outcome Measures
Accuracy was the agreement between women's perceived and objective 10-year risk for breast cancer as measured by the Gail score.⁸ Perceived risk was assessed on a 0 (certain not to happen) to 100 (certain to happen) scale. Breast cancer risk factors were used to calculate a Gail score.⁸ Accuracy was computed as the difference between the woman's perceived and objective risk score. The woman's perception was accurate unless the absolute value of the difference score exceeded 10%.⁹

Level of confidence in ability to understand the risks and benefits of HRT, make a decision about HRT, and discuss HRT with a health care provider was rated (0 = low to 10 = high; Cronbach = .78). Items were summed to yield an average level of confidence.

Women's satisfaction was assessed by agreement (1 = strongly disagree to 5 = strongly agree) with 6 statements related to being informed about HRT, whether the decision (for those who made a decision) was consistent with their personal values, and overall satisfaction with the decision among those who had made a decision (Cronbach = .78).¹⁰

Statistical Analysis
Logistic regression models were tested to predict dichotomized confidence (based on the median baseline value), accuracy of perceived breast cancer risk, and satisfaction outcomes at each follow-up. Covariates were intervention arm, baseline value, race/ethnicity, education, marital status, working for pay, perceived menopausal status, ever use of HRT, hysterectomy status, decision status, and numeracy (for the accuracy outcome).

	RESULTS

TOP INTRODUCTION METHODS RESULTS DISCUSSION References

 
Recruitment and Follow-Up
Of the 2388 telephone numbers called, 158 (7%) numbers were not working, 844 (35%) people were ineligible, 444 (19%) calls were never answered, and 361 (15%) people refused to participate. Of the 581 women who were randomized, 557 (96%) and 541 (93%) completed the 1- and 9-month surveys, respectively. Complete data are available for 520 (90%) of the women.

Study Outcomes
Women in the active intervention arm were significantly less likely than those in the delayed arm to be working for pay (P = .01) and to have had a hysterectomy (P = .02) (Table 1).

Accuracy of perceived risk for breast cancer. At both follow-ups, women in the active arm were more likely to accurately perceive their level of risk for breast cancer than were those in the delayed arm (1 month: OR = 1.9; 95% CI = 1.3, 2.9; 9 months: OR = 1.9; 95% CI = 1.2, 2.8, respectively). Among those with accurate risk perceptions at 1 month, women in the active arm were more likely than those in the delayed arm to retain those perceptions at 9 months (OR = 2.2; 95% CI = 1.3, 3.7).

Satisfaction with decision. At 1 month only, women in the active arm were more likely than those in the delayed arm to report that they were very satisfied with their HRT decision (OR = 2.5; 95% CI = 1.5, 4.3). However, among those who reported being satisfied at 1 month, women in the active arm were more likely than women in the delayed arm to remain satisfied with their decision at 9 months (OR = 2.8; 95% CI = 1.5, 5.3).

	DISCUSSION

TOP INTRODUCTION METHODS RESULTS DISCUSSION References

 
The decision aid improved the accuracy of women's perceptions of breast cancer risk, confidence to make decisions about HRT, and satisfaction with decisions. These intervention effects were sustained between 1- and 9-month follow-ups. HRT decisions might benefit by additional customization or brief telephone counseling calls, which have been effective for other health-related outcomes.¹¹

More than 40% of the undecided women in the active arm made a decision by the 9-month follow-up; in addition, among those decided at baseline and 1 month, women in the active arm reported greater satisfaction at 9-month follow-up than did those in the delayed arm. Providing such decision aids to women before clinic appointments could enable them to make better use of limited visit time.

Although most of the participants were more educated and health oriented than the general population, our use of purchased lists resulted in recruitment of a broader crosssection of women than have been included in prior research on this topic; 24% of our participants (vs 10% of those in previous studies^2,3) were African Americans. Involving community groups should be considered as a means of further expanding intervention reach.

As ever-increasing numbers of women enter menopause, rapidly changing knowledge about HRT requires innovative and flexible communication strategies to meet their information needs.

	Acknowledgments

The authors would like to acknowledge Dr Celette Sugg Skinner for helpful comments on earlier drafts. The authors also thank Maragatha Kuchibhatla and Pauline Lyna, who assisted in data analyses, and Pamela Harris for her assistance in preparing the manuscript.

	Footnotes

 
All authors contributed to the conception, analysis, interpretation, and writing of the brief. C. M. McBride, L. A. Bastian, L. Fish, I. M. Lipkus, H. B. Bosworth, B. K. Rimer, and I. C. Siegler were key to the development, implementation, and evaluation of the intervention. C. M. McBride, L. A. Bastian, S. Halabi, and I. C. Siegler oversaw data collection, analysis, and interpretation.

Peer Reviewed

Accepted for publication May 23, 2001.

	References

TOP INTRODUCTION METHODS RESULTS DISCUSSION References

 
1. O'Connor AM, Fiset V, DeGrasse C, et al. Decision aids for patients considering options affecting cancer outcomes: evidence of efficacy and policy implications. J Natl Cancer Inst Monogr.1999;25:67–80.

2. Rothert ML, Holmes-Rovner M, Rovner D, et al. An educational intervention as decision support for menopausal women. Res Nurs Health.1997;20:377–387.[Medline]

3. O'Connor AM, Tugwell P, Wells GA, et al. Randomized trial of a portable, self-administered decision aid for postmenopausal women considering long-term preventive hormone therapy. Med Decis Making.1998;18:295–303.[Abstract/Free Full Text]

4. Hampson SE, Hibbard JH. Cross-talk about the menopause: enhancing provider-patient interactions about the menopause and hormone therapy. Patient Educ Couns.1996;27:177–184.[Medline]

5. Rimer BK, Conaway M, Lyna P, et al. The impact of tailored interventions on a community health center population. Patient Educ Counseling.1999;37:125–140.[Medline]

6. Kreuter MW. Dealing with competing and conflicting risks in cancer communication. J Natl Cancer Inst.1999;25:27–35.

7. Bastian LA, McBride CM, Fish L, Lipkus IM, Rimer BK, Siegler I. Evaluating participants' use of an HRT decision-making intervention. Patient Educ Couns. In press.

8. Gail MH, Brinton LA, Byar DP, et al. Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst.1989;81:1879–1886.[Abstract/Free Full Text]

9. Lerman C, Lustbader E, Rimer B, et al. Effect of individualized breast cancer risk counseling: a randomized trial. J Natl Cancer Inst.1995;87:286–292.[Abstract/Free Full Text]

10. Holmes-Rovner M, Kroll J, Rovner DR, et al. Patient decision support intervention: increased consistency with decision analytic models. Med Care.1999;37:270–284.[Medline]

11. McBride CM, Rimer BK. Using the telephone to improve health behavior and health service delivery. Patient Educ Couns.1999;37:3–18.[Medline]

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