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Decision Support for Patients With Early-Stage Breast Cancer: Effects of an Interactive Breast Cancer CDROM on Treatment Decision, Satisfaction, and Quality of Life

From the Academic Medical Center, University of Amsterdam; Departments of Medical Psychology, and Clinical Epidemiology & Biostatistics; Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam; St. Anna Hospital, Geldrop; and Medical Spectrum Twente, Enschede, the Netherlands.

Address reprint requests to Sjaak Molenaar, MA, Academic Medical Center/University of Amsterdam, Department of Medical Psychology (J4-401), P.O. BOX 22 660, 1100 DD Amsterdam, the Netherlands; email: J.Molenaar{at}AMC.UvA.NL

	ABSTRACT

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
PURPOSE: To investigate the effects of the Interactive Breast Cancer CDROM as a decision aid for breast cancer patients with a choice between breast conserving therapy (BCT) and mastectomy (MT).

PATIENTS AND METHODS: Consecutive patients with stage I and II breast cancer were enrolled. A quasi-experimental, longitudinal, and pretest/posttest design was used. Follow-up was scheduled 3 and 9 months after discharge from the hospital. Control patients (n = 88) received standard care (oral information and brochures). The CDROM was provided to patients in the experimental condition (n = 92) as a supplement to standard procedures. Outcome variables were treatment decision, satisfaction, and quality of life (QoL).

RESULTS: No effect on treatment decision was found. CDROM patients expressed more general satisfaction with information at 3 and 9 months (95% confidence interval for the difference (d) between the means (d: 4.1 to 12.5 and 5.7 to 14.2 respectively). CDROM patients were also more satisfied with their treatment decision at 3 and at 9 months (d: 0.1 to 0.4; 0.2 to 0.5). Moreover, at 9 months, CDROM patients were more satisfied with breast cancer–specific information (d: 0.9 to 16.5), the decision-making process (d: 0.1 to 0.4), and communication (d: 0.2 to 11.0). At 3 and 9 months, a positive effect was found on general health (d: 0.2 to 14.5 and 0.3 to 15.0). Moreover, at 9 months, CDROM patients reported better physical functioning (d: 5.1 to 19.8), less pain (d: -17.9 to -4.5), and fewer arm symptoms (d: -14.1 to -0.5).

CONCLUSION: The Interactive Breast Cancer CDROM improved decision making in patients with early-stage breast cancer with a choice between BCT and MT, as evaluated in terms of patients’ satisfaction and QoL.

	INTRODUCTION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
In contemporary health care, the importance of patient education and patient involvement in medical decision making is being increasingly advocated.^1-6 Beneficial effects of informing patients about treatment options and inviting them to participate in the choice of treatment have been suggested, for example, with regard to patient compliance,⁷ patient satisfaction,^8-11 clinical outcomes,^12-13 and quality of life (QoL).^14-17

In a model of shared decision making, the treatment decisions are made in close cooperation between the physician and patient.³ Much emphasis is given on the exchange of information. Physicians provide patients with evidence-based information on treatment options and outcomes. In return, patients express their personal values and preferences with regard to the available treatment alternatives. When clinical information and patients’ personal values are "on the table," the patient and the physician can discuss the alternatives and together decide on the course of action. However, shared decision making is not a common phenomenon yet.^18-21

Decision aids have been devised to facilitate shared decision making.²² Decision aids present the information believed to be necessary for patients to consider when more than one treatment alternative is available. The treatment alternatives and varying outcomes are outlined, and patients are encouraged to consider their values to achieve an informed decision, one that best addresses their personal needs. As it is believed that improved decision making will contribute to patients’ satisfaction and health outcomes, these interventions have been welcomed with enthusiasm. Still, questions about the feasibility and effectiveness of decision aids have also been raised.

First, critics question whether patients indeed want decision responsibility.^23,24 Decision aids may be confusing, may increase patients’ distress, and could induce avoidance reactions.²³ Moreover, patients choosing a treatment that subsequently proves unsuccessful might experience feelings of self-blame and regret.²³ Second, physicians’ attitudes toward providing decision aids are largely unknown.²⁵ Physicians may not be supportive, as the evidence about the efficacy of decision aids is scant. Furthermore, they may feel reluctant to give decision responsibility to patients, as this could lead to a loss of confidence in the physician and thus damage the doctor-patient relationship. Physicians could also conceive that involving patients more closely in treatment choices is unfeasible and time consuming,²⁶ thus resulting in less time for other tasks considered critical to patient care. Finally, critics fear that patients making decisions could lead to a greater demand for futile, expensive, or harmful interventions.²⁴ However, the pros and cons of decision aids are largely unknown, and studies evaluating their contribution to health care are therefore needed.

In stage I and II breast cancer, breast conserving therapy (BCT) and mastectomy (MT) are equally effective in terms of survival and QoL.^27-28 It is generally agreed that the choice between BCT and MT is a value-laden decision and belongs to the individual patient. Some may opt to undergo BCT to preserve their body image, while others may prefer MT for reasons including the unwillingness to undergo radiotherapy, the wish to minimize the chance of local recurrence, or both. Studies consistently show that the need for information among breast cancer patients is high and that most patients want to participate in the decision.²⁹

Several decision aids have been developed for the clinical scenario of breast cancer, including decision boards,^30,32 an audiotape-booklet combination,³³ interactive computer programs^34-35 and a counseling/video program.³⁶ These decision aids have been evaluated positively in terms of feasibility and acceptance to patients. For example, the decision board recently evaluated by Whelan et al³² was found easy to understand, helpful to patients, and easy to administer. Comparable studies have reported similar findings.^30-36 Moreover, studies indicate that a breast cancer decision aid can positively affect patients’ knowledge and level of decisional conflict.^33,36 Notwithstanding the meaningfulness of these studies, the primary aim in health care is to improve patients’ health status and QoL. A successful decision aid should, therefore, also lead to improvements in those outcomes.^37,38 However, the effect of decision aids on health and QoL in breast cancer patients has not been addressed and is poorly understood.^22,39

In an effort to facilitate shared decision making in stage I and II breast cancer patients with a choice between BCT and MT, the Interactive Breast Cancer CDROM was developed as a decision aid. The present study was designed to examine the extent to which the CDROM program affects the decision between BCT and MT, patients’ satisfaction, and QoL.

	PATIENTS AND METHODS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
Intervention
The Dutch breast cancer support group for patients, as well as representatives from the medical disciplines involved in breast cancer management, participated in the development of the CDROM. Both groups reviewed literature, discussed personal experiences with breast cancer, and formulated recommendations. A program prototype was then constructed based on treatment guidelines⁴⁰ and on the subjective experiences of patients. An interactive device was chosen to allow patients to select those topics in which they were interested. A multimedia computer with a 21-inch color monitor, a printer, and a trackball were used.

The CDROM presents combinations of still images, video, and text with underlying verbal explanations from physicians (a general practitioner, a surgeon, a radiologist, and an oncologist) and fellow patients. Written summaries of selected parts of the program can be printed, such as a summary on the potential pros, cons, and uncertainties of BCT and MT.

The prototype program was pretested in 1994 to 1995 in 25 breast cancer patients with a choice between BCT and MT.⁴¹ The pilot study revealed that (a) the program is feasible in daily clinical practice, (b) patients considered the interactive device an acceptable way to receive information, (c) patients found the information provided to be clear, and (d) patients believed the program helped them to think about both treatment options. The pilot results were used to refine the program’s informational content and to develop a final strategy for implementation and evaluation.

The resulting CDROM was evaluated in this study. Its informational content is arranged in a menu structure. A main menu ( Fig 1) serves as a table of contents that depicts eight underlying submenus (see the appendix for the informational content of each submenu). The picture in the center of the main menu is used to start an introduction of the program addressing its objectives and services.

View larger version (105K): [in this window] [in a new window]   Fig 1. A main menu serves as a table of contents that depicts eight underlying submenus.

Data on the characteristics of the CDROM viewing were saved into so-called logfiles. Preliminary analysis (based on the first 70 patients) of these logfiles reveal that the mean total viewing time was 70 minutes (range: 23 to 120 minutes). The submenu on BCT was most popular; it was visited by 68 patients (97%). Patients visiting the BCT submenu were especially interested in the sections devoted to the surgical procedure (n = 58 patients; 83%) and the advantages and disadvantages of BCT (n = 58; 83%). Forty-one patients (59%) printed a sheet with a description of the potential pros and cons of BCT.

Fifty-five patients (79%) visited the submenu devoted to MT. Patients most frequently visited the sections on the advantages and disadvantages of MT (n = 41; 59%) and viewed photos of its cosmetic result (n = 41; 59%). Thirty patients (43%) printed the sheet with potential pros and cons of MT.

Hospitals and Patients
The Interactive Breast Cancer CDROM was implemented in three Dutch hospitals. One was a cancer hospital with 180 beds (hospital A) and two were general hospitals (B, C) with 427 and 1,070 beds, respectively. Hospital A and C are accredited teaching hospitals and have a radiation department, whereas patients from hospital B receive radiation in a neighboring clinic (travel distance = 15 miles). Consecutive patients, newly diagnosed with stage I and II breast cancer were eligible for the study. They were invited to participate in the study by their treating surgeon after (s)he had decided that both BCT and MT were acceptable treatment options. Insufficient understanding of Dutch, as judged by the surgeon, was the only exclusion criterion. Patient accrual started in March 1996. Follow-up was completed in October 1998.

Study Design
A conventional randomization procedure was considered inappropriate. Randomizing individual patients or surgeons might lead to an underestimation of the effect of the CDROM program, as the experimental CDROM program would likely contaminate standard procedures.

Moreover, the pilot study revealed that patients perceived the CDROM as an attractive, favorable intervention. Patients would want to have access to the program once they learned about its availability in their hospital. We felt it would be unethical to deny some patients access to the CDROM program, even though its effects were still uncertain, when it would be available to other patients in the same hospital.

Faced with the limitations of a standard randomization design, a quasi-experimental, longitudinal, pretest/posttest design was chosen. Such a design enables treating all patients in a certain time period equally. However, in a pretest/posttest design, changes over time might confound pretest/posttest periods (so-called "history effects"). The CDROM program was therefore introduced with intervals ( Table 1). Three inclusion periods of 6 months were created. During the first period, the CDROM was only used in hospital B, and eligible patients from this clinic were included in the CDROM condition. Eligible patients in hospital A and C were included in the control condition. In the second period, the CDROM was withdrawn from hospital B and implemented in hospitals A and C. During that period, eligible patients from hospital B served as control group patients, whereas patients from hospitals A and C were included in the CDROM condition. In the third period, CDROM and control condition were reversed again. To prevent the possibility that CDROM effects would carry over to the standard care condition, no patients were entered into the study in the month following the completion of a CDROM period.

Patients in the standard care condition were offered oral information by their surgeons, and they made a preliminary choice of surgery in the consultation in which the diagnosis was revealed. They were offered brochures to promote information recall and further deliberation regarding the preliminary treatment choice. In general, a definite choice was made at the day of the patients’ admission to the hospital for surgery for both the standard care condition and the CDROM condition.

During an intervention period, a CDROM viewing was scheduled routinely within 1 week after diagnosis as an adjunct to the standard procedures in a control period. The CDROM viewing took place during a special appointment at the outpatient department. Patients used the CDROM while a breast cancer nurse specialist was present. The nurse specialist met the patient and started the CDROM program. The research protocol prescribed that the nurses would not provide information. However, they were allowed to provide emotional support and practical help to patients who experienced difficulties while using the computer equipment. At the end of the viewing, patients were offered a follow-up visit with their surgeon to discuss what they had learned. The CDROM viewing was scheduled within the customary waiting time for surgery and did not postpone patients’ admission to the hospital. The medical care patients received after they had their surgery and were discharged from the hospital was the same in both study conditions.

Patients in the CDROM condition returned their baseline questionnaire before the special CDROM appointment, whereas the standard care condition returned the questionnaire by mail before admission to the hospital. Follow-up questionnaires containing outcome measures were mailed at 3 and 9 months after discharge from the hospital after BCT or MT surgery.

Measures
Background Variables. To correct for possible confounders in this study, patients’ background variables were assessed on entry to the study, including sociodemographic and clinical background, treatment preference, decision style, decision uncertainty, and QoL. Patients’ treatment preferences were measured with a single question and a five-point answering scale, ranging from "certainly MT" to "certainly BCT."

To be able to control for differences in patients’ decision style, "avoidance," "deferring responsibility," "information seeking," and "deliberation" were assessed. We used the Michigan Assessment of Decision Style (MADS),⁴³ which was developed and validated specifically for decision making in early-stage breast cancer. The MADS was translated into Dutch by two bilingual individuals, using a forward-backward translation procedure.

To be able to control for differences in the patients’ level of uncertainty regarding the decision, two subscales of the Decisional Conflict Scale⁴⁴ (DCS) were translated into Dutch (according to the same procedures used with the MADS). The first subscale measures patients’ level of uncertainty about the decision they are confronted with. The second subscale measures the extent to which patients feel informed, have clear values, and perceive social support. The DCS has proven to be valid and reliable in different health care decision-making contexts.⁴⁴

Baseline generic QoL was assessed with the Medical Outcomes Study 20 (MOS20),⁴⁵ which measures six generic aspects of QoL (general health, physical functioning, pain, role functioning, social functioning, and psychological functioning) and has an additional energy subscale. The MOS20 has adequate levels of reliability and validity⁴⁵ and was translated into Dutch according to standard forward-backward procedures.⁴⁶

Additionally, a breat-cancer specific QoL questionnaire developed by the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-BR23) was administered to assess baseline breast cancer–specific functioning and symptoms⁴⁷ (body image, sexual functioning, arm symptoms, breast symptoms, systemic therapy symptoms, and future perspective). The psychometric quality of this originally Dutch instrument has been well established.⁴⁷

Outcome Variables. The first outcome to be considered was the actual treatment that a patient had chosen. Data on the treatment decision made (BCT or MT) and on the need to undergo subsequent adjuvant therapies were collected at 3 months.

Satisfaction measures addressed satisfaction with (a) information, (b) the decision-making process, (c) the treatment decision, and (d) care. We developed two multi-item instruments to measure satisfaction with information. The first instrument contained six items with a five-point response scale and evaluated patients’ satisfaction with the amount, clarity, and usefulness of the information they had received (general satisfaction with information). The second scale contained five items with a four-point response scale and evaluated satisfaction with treatment-specific information. Patients were asked to evaluate the content of the information they had received about radiotherapy, local recurrence, and the cosmetic results of the two alternative treatments. Satisfaction with the decision-making process was elicited by a four-item scale, with a four-point response format, which was developed for the study. This scale was used to assess the degree to which patients perceived they were (a) offered sufficient time to arrive at a decision, (b) given opportunities to ask questions, and (c) provided with support from their physician to make a decision. Satisfaction with the decision made was measured with three out of four items of the "effective decision-making" subscale of the DCS.⁴⁴ The items used in this study were related to the extent to which patients believed their choice of surgery was well informed and consistent with personal values and the extent to which patients are satisfied with their choice. The fourth DCS-item "I expect to stick with my decision" was considered to be irrelevant for patients undergoing MT and therefore deleted. Satisfaction with care was measured with the Patient Satisfaction Questionnaire⁴⁸ encompassing general satisfaction and satisfaction with (a) the technical quality of care, (b) the interpersonal aspects of care, (c) the communication with physicians, and (d) the availability of the physician. The Patient Satisfaction Questionnaire was validated previously⁴⁸ and translated into Dutch according to standard procedures forward-backward procedures.⁴⁹

Generic QoL and breast cancer–specific functioning and symptoms were assessed at follow-up with the same QoL instruments (ie, the MOS20 and the EORTC QLQ-BR23) that were administered at baseline (see Background Variables).

Analyses
A priori estimation of sample size was based on an expected small to medium improvement (d = 0.4) in QoL in the CDROM condition. One hundred fifty-six patients are needed to achieve a statistical power of 80% in univariate analyses with significance levels set at 0.05.⁴²

All patients enrolled in the predetermined CDROM periods were classified as "CDROM cases." All patients included during the remaining periods were classified as "controls." Thus, data analysis was organized by the principle of "intention-to-treat."

For missing items, imputation of the mean of the remaining items was performed when at least 50% of the scale items were completed. Internal consistency was calculated (Cronbach’s coefficients) for all multi-item scales used in this study. Two MADS subscales ("deferring responsibility" and "avoidance" had modest reliability (0.62 to 0.64) as well as three EORTC QLQ-BR23 subscales (arm, breast, and systemic therapy symptoms) (range: 0.58 to 0.65). Reliability of all other scales used in this study was found to be satisfactory (range: 0.76 to 0.89).

Before assessing the effectiveness of the CDROM program on the outcome measures in this study, a search for the effects of "hospital" and "inclusion period" on background and outcome variables was performed, as these factors may be confounding variables in this study. Student’s t tests, ²-tests, or multivariate analyses of variance (MANOVAs)⁵⁰ were employed, depending on the type and distribution of the data. For the purpose of these analyses, a conservative significance level of P < .10 was used. If effects of "hospital," "hospital-by-condition," "period," or "period-by-condition" were found, these factors were entered as covariates in subsequent analyses in which we organized the data by "condition" (CDROM versus standard care) as the only between-group factor.

Moreover, analyses were performed to detect potential differences in background variables between patients in the CDROM and standard care condition. Again, Student’s t tests, ²-tests, or MANOVAs were employed and a conservative significance level of P < .10 was used. If patients in the CDROM and standard care condition were found to be incomparable with respect to certain background variables, these variables were entered as covariates in the analyses of the effectiveness of the CDROM program.

The effectiveness of the CDROM program was then analyzed. P values < 0.05 were considered to be significant. The effect of the intervention on the treatment decision (BCT or MT) was analyzed with the ² test. To test for the effectiveness of the intervention on satisfaction and QoL, MANOVAs for repeated measurements were used. "Time" (3 and 9 months follow-up) was used as the within-subjects factor. When a multivariate difference between patients in the CDROM and standard care conditions was observed, subsequent univariate tests were conducted to establish which variables contributed to the overall difference.

	RESULTS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
Included Patients
One-hundred eighty-nine patients were presented to the research coordinator. Nine patients decided not to participate, resulting in a sample of 180 eligible patients at baseline (95% acceptance rate). Informed consent was obtained from all participants.

At 3 months follow-up, eight subjects (4%) dropped out of the study (CDROM: n = 2; standard care: n = 6). These patients felt too ill (standard care: n = 3), were no longer motivated (CDROM: n = 1; standard care: n = 2), or had died (standard care: n = 1).

Five patients (3%) were lost to follow-up at 9 months (CDROM: n = 2; standard care: n = 3). One patient had died (standard care: n = 1), and four were no longer motivated (CDROM: n = 2; standard care: n = 2). Thus, the number of full cases was 180 - (8 + 5) = 167 subjects (CDROM n = 88 (97%); standard care n = 79 (90%); combined: 93%).

According to the intention-to-treat principle, three patients (3%) were included in the CDROM condition, although they declined the opportunity to use the program. These patients said they had already decided on their treatment and did not need additional information. No patients in the standard care condition used the CDROM.

Effects of "Hospital" and "Period"
No significant effects of "hospital" or "period" were found on patients’ background variables. The patients’ treatment decision was not related to "hospital" or "period" either. However, a significant effect of "hospital" was found on satisfaction (F(18;270) = 1.80; P = .03). Patients from hospital B reported more satisfaction compared with patients from hospital A and C. Satisfaction scores were lowest in hospital A (data not shown). Consequently, when the effectiveness of the CDROM program on satisfaction was tested, "hospital" was entered as a covariate. Moreover, a "period-by-condition" interaction effect was found on generic QoL (F(14;276) = 1.76; P = .05). CDROM patients in the third inclusion period reported better generic QoL than others. Consequently, when the effectiveness of the CDROM condition on generic QoL was assessed, "period" and "period-by-condition" were entered as covariates. Breast cancer–specific QoL was not related to "hospital" or "period."

Patients’ Background Variables by Condition
Background data, grouped by condition, are presented in Tables 2 and 3. No differences between the CDROM and standard care condition were found on sociodemographic background, treatment preference, and disease-related characteristics (ie, lymph node status, need for radiotherapy, or adjuvant chemotherapy or hormone therapy). Patients in the CDROM and standard care condition were also comparable for decision style and QoL but not for decisional conflict (F(2;175) = 8.33; P < .01; Table 3). Decisional conflict was therefore entered as covariate in the subsequent MANOVAs to establish the effectiveness of the CDROM program.

Effect of the CDROM Program on Satisfaction
An overall positive effect of the CDROM was found on satisfaction (F (9;138) = 2.99; P < .01; Table 4) indicating that patients in the CDROM condition were more satisfied than patients in the standard care condition. No effect of "time" was found (F (9;138) = 1.57; P = .13), indicating that patients reported comparable levels of satisfaction at 3 and 9 months. No time-by-condition interaction effect was found either (F(9,138) = 1.54; P = .14). Subsequent univariate analyses revealed that patients in the CDROM condition reported more overall satisfaction with information and satisfaction with their treatment decision at 3 months follow-up than patients in the standard care condition. At 9 months follow-up, the patients in the CDROM condition expressed more satisfaction with information received (general satisfaction as well as satisfaction with breast cancer–specific information), the decision-making process, the treatment decision, and communication with physicians than control patients.

	DISCUSSION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

An important question is whether the observed results have clinical relevance. First, unlike many other studies on decision aids in which hypothetical patients were used, the sample in this study encompassed real patients with breast cancer who were actually facing the decision between BCT and MT. This study is therefore more meaningful. Second, clinical relevance also depends on the magnitude of the differences found between study conditions. In this study, the effect-sizes for the different aspects of satisfaction were substantial. The largest difference between the study conditions was found for satisfaction with general information. The magnitude of the effect was nearly 0.8 of a SD, which is considered to be a large effect.⁴² In addition, the magnitude of the other significant differences in satisfaction can be classified as small to moderate. Moreover, the effects on satisfaction occurred with gains in QoL. The magnitude of the effects on QoL can be classified as small (for general health and arm symptoms; 0.3 of a SD) to moderate (for physical functioning and pain; 0.5 of a SD). In general, research has shown that large improvements on QoL are uncommon. Most patients with early-stage breast cancer tend to adjust well to their disease and additional gains in QoL are not easily achieved. The small to moderate improvements in QoL that were found in this study are therefore considered worthwhile. When considered in conjunction with the improvements that were found in satisfaction, we believe that this study is meaningful for clinical practice.

Some limitations of this study need to be discussed. To measure satisfaction with information and the decision-making process, instruments were developed specifically for this study. These instruments were evaluated by the members of the research team, including a patient representative, a surgeon, health educators, and researchers in the field of psychology. Face-validity of the instruments was judged to be satisfactory. Moreover, the instruments developed for this study were found to have satisfying levels of reliability (Cronbach’s > 0.76). Nevertheless, it should be recognized that formal validation of these measures was not established. Additionally, selective subscales of the MADS and the EORTC QLQ-BR23 had modest levels of reliability (Cronbach’s 0.58 to 0.65). However, the clinical validity of these instruments has been found to be excellent^43,46 as was the responsiveness to clinical chance (EORTC QLQ-BR23 only).⁴⁶

Another aspect to be considered is whether the potential danger of contamination, due to the quasi-experimental nature of the design, has been adequately accounted for. The study design prevented patients in the standard care condition from having access to the CDROM. Still, contamination bias might be possible when physicians, consciously or unconsciously, change their communication with patients in the standard care condition due to feedback from patients about the CDROM. If this occurred, the results of this study would portray an underestimation of the real effect of the intervention. However, subgroup analysis comparing the outcomes of patients from pre- and post-CDROM periods (Table 1) did not reveal differences, suggesting that contamination bias was negligible.

Because of the nonrandom allocation, patient selection was a priori identified as a potential source of bias. Patient selection was indeed suspected, as patient accrual was unbalanced with more patients being included during the four CDROM periods. However, baseline comparisons between both study conditions did not reveal significant differences, except for the level of decisional conflict. This factor was statistically controlled for in the analyses. Hence, confidence in the a priori equivalence of both study conditions is justified for the variables that were measured at baseline. However, we must consider that the nonrandom study design does not exclude the possibility that the study conditions could be different with regard to unknown factors not measured in this study.

The CDROM was used in the context of a study project. Patients in this study may have received more personal attention than patients commonly receive. In addition, physicians and nurses participating in the study were supported by the research coordinator, which also can affect the decision aid’s success. Also, the effects found in this study may be explained by the simple fact that a new and original means of patient education was tested, the so-called "bias-by-novelty" effect. Moreover, patients participating in the study may have been more motivated to engage in decision making after completing the baseline questionnaire. If these assumptions are true, the beneficial effects found in this study could be smaller in the realm of daily clinical practice.

A factor that complicates the interpretation of the study results is the lack of insight into the content and dynamics of the appointments between patients and their surgeons. We have not been able to systematically collect data about the way diagnosis and treatment options were actually presented and discussed. Previous studies have found that physicians influence the treatment decisions of patients.^51,52 If the surgeons in this study were an influential factor in decision making, this would explain the absence of a difference in the treatment choices between the conditions. We must also recognize that decision making is not restricted to the patient–health care professional dyad.³ For example, family members, friends, and reports in the media may all have influenced patients’ treatment choices. We should be aware that not only patients but also their friends and relatives should receive health care information that is of high quality.

In addition, no information is available on the dynamics of the interaction between patients and the nurse specialist during the appointment in which the CDROM was viewed. Previous studies have found a relationship between nursing interventions and improved patient satisfaction and outcomes.⁵³ In this study, the nurses were instructed not to provide health information and only to provide practical and emotional support if requested. In reality, the nurses were not able to fully comply with this instruction (personal communications). Consequently, the study findings need to be considered as the result of a joint CDROM plus nurse intervention: for example, the nurses might have raised patients’ awareness of potential arm problems, shoulder problems, or both following surgery. In reaction, patients may have become more sensitive to the information provided in the CDROM on preventive and self-care behaviors.

Despite the limitations of this study, the CDROM as such may have contributed directly to the results found. Patients in the CDROM condition may have been better informed as a result of the interactive device and the use of different formats of information than patients in the standard care condition. Remarkably, few patients used the opportunity to have an additional consultation with their surgeon after the CDROM viewing to discuss what they had learned (personal communications). Moreover, only one or two patients requested a second viewing of the CDROM. These experiences suggest that most patients’ informational needs were sufficiently fulfilled and that the CDROM experience did not provoke anxiety or confusion in patients.

To our knowledge, this is only the second controlled study that demonstrates improved outcomes for patients offered a decision aid. The current results are comparable with those of an earlier study evaluating a comparable, interactive program on benign prostate hyperplasia.¹⁷ This study also found improved satisfaction with the decision-making process and favorable general health and physical functioning for patients provided with interactive information. Remarkably, the study by Barry et al also found that the beneficial effects of the interventions were more evident at long-term follow-up. As an explanation for this finding in our study, we would like to point out that patients at 3 months follow-up had only recently finished their treatment. At this point, patients’ evaluations of care and QoL might primarily be associated with a general feeling of relief "that normal life can continue." If such positive feelings are generally paramount in patients shortly after treatment, large differences between the two study conditions cannot be expected at this time. Moreover, improved patient compliance toward exercises to prevent or reduce common side effects of treatment (eg, numbness and loss of strength in arm or shoulder, lymphedema) could provide an explanation for the long-term effects found in this study. Possibly, patients in the CDROM condition may have been more empowered to successfully integrate rehabilitation exercises in their normal routine, resulting in favorable QoL and satisfaction in the long run.

For many diseases, multiple effective treatments exist, often with varying and uncertain outcomes. Decision aids to facilitate shared decision making have been developed. Few have been systematically evaluated and when studied, the beneficial effects appear to be disappointing.^22,39 More controlled studies are needed, if possible using a randomized design. Ideally, these studies would monitor process variables, use standardized instruments, and have long-term follow-up. Moreover, researchers evaluating decision aids with multiple components could choose a study design that takes into account the relative contributions of separate program components.

In the same time, we conclude that the desired effects of decision aids are demonstrated in this study. The use of the Interactive Breast Cancer CDROM, as administered in this study, improved patients’ satisfaction and QoL. We are now facing the development of a structure for timely updating and distributing of the CDROM. Further development of comparable decision support programs and their evaluation should be encouraged to promote the well-being of cancer patients.

	APPENDIX

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 

	ACKNOWLEDGMENTS

This study was supported by the Dutch Cancer Society (grant number AMC95-891). We thank the two anonymous reviewers for their helpful and constructive comments. We thank F. J. Oort for his statistical advice during the preparation of this paper. We kindly thank L. Krol for his support of the CDROM’s development and evaluation. We thank M. Omtzigt, A. van der Ploeg, L. van Reeven-de Ruijter, G. Bokma, M. Kisters, and L. Geulen, who, as members of the Dutch breast cancer support group contributed to the development of the CDROM. We also thank A. Eijsten, E. Fokke, T. Chanowski, C. Koning, J. de Vries, G. Botke, P. van Velthoven, C. Veenhof, JB de Boer, P. Borst, F. Postma, G. Donner, and J. Haagens for their contribution in the CDROM’s developmental process. T. van der Sluis, G. van den Hurk, M. van Wijngaarden, and G. Grevink and the members of their teams are kindly acknowledged for their contribution to the implementation of the CDROM and their support of the study in their hospitals.

	REFERENCES

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
1. Emanuel EJ, Emanuel LL: Four models of the doctor-patient relationship. JAMA 267: 2221-2226, 1996

2. Laine C, Davidoff F: Patient centered medicine: A professional evolution. JAMA 275: 152-156, 1996[Abstract/Free Full Text]

3. Charles C, Gafni A, Whelan T: Decision-making in the physician-patient encounter: Revisiting the shared treatment decision-making model. Soc Sci Med 49: 651-661, 1999

4. Kasper JF, Mulley AG, Wennberg JE: Developing shared decision-making programs to improve the quality of health care. Qual Rev Bull 18: 183-190, 1992

5. Llewellyn-Thomas HA: Patients’ health-care decision making: A framework for descriptive and experimental investigations. Med Decis Making 15: 101-106, 1995[Free Full Text]

6. Borne, HW van den: The patient from receiver of information to informed decision-maker. Patient Educ Couns 34:89-102, 1998

7. Haynes RB, McKibbon KA, Kanani R: Systematic review of randomised trials of interventions to assist patients to follow prescriptions for medications. Lancet 348: 383-386, 1996[Medline]

8. Brody DS: The patient’s role in clinical decision-making. Ann Intern Med 93: 718-722, 1980

9. Weiss SM, Wengert PA, Martinez EM, Warren S, Kopp E: Patient satisfaction with decision-making for breast cancer therapy. Ann Surg Oncol 3: 285-289, 1996[Medline]

10. Kinmonth Al, Woodcock A, Griffin S, et al: Randomised controlled trial of patient centred care of diabetes in general practice: Impact on current wellbeing and future disease risk. BMJ 317: 1202-1208, 1998[Abstract/Free Full Text]

11. Moyer A, Salovey P: Patient participation in treatment decision making and the psychological consequences of breast cancer surgery. Womens Health 4: 103-116, 1998[Medline]

12. Greenfield S, Kaplan S, Ware JE: Expanding patient involvement in care: Effects on patient outcomes. Ann Intern Med 102: 520-528, 1985

13. Greenfield S, Kaplan S, Ware JE, et al: Patients’ participation in medical care: Effects on blood sugar control and quality of life in diabetes. J Gen Intern Med 3: 448-457, 1988[Medline]

14. Stewart MA: Effective physician-patient communication and health outcomes: A review. J Can Med Assoc 152: 1423-1433, 1995[Abstract]

15. Fallowfield L: Offering choice of surgical treatment to women with breast cancer. Patient Educ Couns 30: 209-214, 1997[Medline]

16. Street RL Jr, Voigt B: Patient participation in deciding breast cancer treatment and subsequent quality of life. Med Decis Making 17: 298-306, 1997[Abstract/Free Full Text]

17. Barry MJ, Cherkin DC, Chang Y, et al: A randomised trial of a multimedia shared decision-making program for men facing a treatment decision for benign prosthetic hyperplasia. Dis Manage Clin Outc 1: 5-14, 1997

18. Braddock CH 3rd, Fihn SD, Levinson W, et al: How doctors and patients discuss routine clinical decisions: Informed decision making in the outpatient setting. J Gen Intern Med 12: 339-345, 1997[Medline]

19. Elwyn G, Edwards A, Kinnersley P: Shared decision-making in primary care: The neglected second half of the consultation. Br J Gen Pract 49: 477-482, 1999[Medline]

20. Braddock CH 3rd, Edwards KA, Hasenberg NM, et al: Informed decision making in outpatient practice: Time to get back to basics. JAMA 282: 2313-2320,

21. Stevenson FA, Barry CA, Britten N, et al: Doctor-patient communication about drugs: The evidence for shared decision making. Soc Sci Med 50: 829-840,

22. O’Connor AM, Rostom AR, Tetroe J, et al: Decision aids for patients facing health treatment or screening decisions: Systematic review. BMJ 319: 731-734, 1999[Abstract/Free Full Text]

23. Richards MA, Ramirez AJ, Degner LF, et al: Offering choice of treatment to patients with cancers: A review on a symposium held at the 10th annual conference of the British psychosocial oncology group, December 1993. Eur J Cancer 31A: 112-116, 1995

24. Coulter A: Partnerships with patients: the pros and cons of shared clinical decision-making. J Health Serv Res Policy 2: 112-121, 1997[Medline]

25. O’Connor AM, Llewellyn-Thomas HA, Sawka C, et al: Physicians’ opinions about decision aids for patients considering adjuvant therapy for axillary-node negative breast cancer. Patient Educ Couns 30: 143-153, 1997[Medline]

26. Towle A, Godolphin W: Framework for teaching and learning informed shared decision making. BMJ 319: 766-771, 1999[Free Full Text]

27. Early Breast Cancer Trialists’ Collaborative Group: Effects of radiotherapy and surgery in early breast cancer: An overview of the randomized trials. N Engl J Med 333: 1444-1455, 1995[Abstract/Free Full Text]

28. Kiebert GM, Haes de JCJM, Velde van de CJH: The impact of breast-conserving treatment and mastectomy on the quality of life of early-stage breast cancer patients: a review. J Clin Oncol 9: 1059-1070, 1991[Abstract]

29. Degner lf, Kristjanson LJ, Bowman D, et al: The patient-physician relationship: Information needs and decisional preferences of in women with breast cancer. JAMA 277: 1485-1492, 1997[Abstract/Free Full Text]

30. Levine MN. Gafni A, Markham B, et al: A bedside decision instrument to elicit a patient’s preference concerning adjuvant chemotherapy for breast cancer. Ann Int Med 117: 53-58, 1992

31. Whelan TJ, Levine MN, Gafni A, et al: Breast irradiation postlumpectomy: Development and evaluation of a decision instrument. J Clin Oncol 13: 847-853, 1995[Abstract]

32. Whelan T, Levine M, Gafni A, et al: Mastectomy or Lumpectomy? Helping women make informed choices. J Clin Oncol 17: 1727-1735, 1999[Abstract/Free Full Text]

33. Sawka CA, Goel V, Mahut CA, et al: Development of patient decision aid for choice of surgical treatment for breast cancer. Health Expectations 1: 23-36, 1998[Medline]

34. Street RL, Voigt B, Geyer C, et al: Increasing patient involvement in choosing treatment for early breast cancer. Cancer 76: 2275-2285, 1995[Medline]

35. Gramlich EP, Waitzfelder BE: Interactive video assists in clinical decision making. Methods Inf Med 37: 201-205, 1998[Medline]

36. Stalmeier PMF, Unic IJ, Verhoef LCG, et al: Evaluation of a shared decision making program for women suspected to have a genetic predisposition to breast cancer. Med Decis Making 19: 1230-1241, 1999

37. Entwistle VA, Snowden AJ, Watt IS: Evaluating interventions to promote patient involvement in decision-making: By what criteria should effectiveness be judged? J Health Serv Res Policy 3: 100-107, 1998[Medline]

38. Frosch DL, Kaplan RM: Shared decision making in clinical medicine: Past research and future directions. Am J Prev Med 17: 285-294, 1999[Medline]

39. Molenaar S, Sprangers MAG, Postma-Schuit FCE, et al: Feasibility and effects of decision aids. Med Decis Making 20: 112-127, 2000[Abstract/Free Full Text]

40. IKA/IKST: Working Group on Mamma Carcinoma: IKA/IKST treatment guidelines Mamma Carcinoma. Amsterdam, the Netherlands, Comprehensive Cancer Center, 1995

41. Molenaar S, Sprangers MAG, De Haes JCJM: An interactive computer program on breast cancer: Reactions of patients and surgeons. Psychooncology 7: 175, 1998 (abstr)

42. Cohen J: Statistical power analysis for the behavioral sciences. Hillsdale, New Jersey, Lawrence Erlbaum Associates, 1988

43. Pierce P: Michigan Assessment of Decision Style (MADS). Ann Arbor, MI, University of Michigan, 1995

44. O’Connor AM: Validation of a decisional conflict scale. Med Decis Making 15: 25-30, 1995[Abstract/Free Full Text]

45. Stewart AL, Ware, JE. (eds): Measuring Functioning and Well-Being: The medical outcomes study approach. Durham, NC, Duke University Press, 1992

46. Sprangers MAG, Groenvold M, Arraras JI., et al: The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life Questionnaire Module: First results from a three-country field study. J Clin Oncol 14: 2756-2768, 1996[Abstract/Free Full Text]

47. Kempen GIJM: Het meten van de gezondheidstoestand van ouderen. Een toepassing van een Nederlandse versie van de MOS-schaal. (Assessment of health status among the elderly; an application of a Dutch version of the MOS-survey.) Tijdschr Gerontol Geriatr 23: 132-140, 1992[Medline]

48. Wilkin D, Hallam L, Doggett M: Measures of patient satisfaction, in Measures of Need and Outcome for Primary Health Care. Oxford, England, Oxford University Press, 1992, pp 230-260

49. Ong LML, Visser MRM, Lammes FB, van der Velden J, Kuenen BC en de Haes JCJM: The effect of providing cancer patients with the audiotaped initial consultation on satisfaction, recall and quality of life: A randomized, double-blind study. J Clin Oncol 18:3052-3060, 2000

50. Stevens J: Applied multivariate statistics for the social sciences. Mahwah, New Jersey, Lawrence Erlbaum Associates, 1996, pp 151-183

51. Siminoff LA, Fetting JH: Factors affecting treatment decisions for a life-threatening illness: The case of medical treatment of breast cancer. Soc Sci Med 32: 813-818, 1991

52. Stafford D, Szczys R, Becker R, et al: How breast cancer treatment decisions are made by women in North Dakota. Am J Surg 176: 515-519, 1998[Medline]

53. Neufeld KR, Degner LF, Dick JAM: A nursing intervention strategy to foster patient involvement in treatment decision. Oncol Nurs Forum 20: 631-635, 1993[Medline]

Submitted December 6, 1999; accepted December 14, 2000.

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