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Impact of Providing Audiotapes of Primary Adjuvant Treatment Consultations to Women With Breast Cancer: A Multisite, Randomized, Controlled Trial

Thomas F. Hack, Tom Pickles, Barry D. Bultz, J. Dean Ruether, Lorna M. Weir, Lesley F. Degner, John R. Mackey

From the Faculty of Nursing, University of Manitoba; CancerCare Manitoba, Winnipeg, Manitoba; British Columbia Cancer Agency, Vancouver, British Columbia; Tom Baker Cancer Centre, Calgary; and Cross Cancer Institute, Edmonton, Alberta, Canada.

Address reprint requests to Thomas Hack, PhD, St Boniface Hospital Research Centre, 351 Taché Avenue, Winnipeg, Manitoba R2H 2A6, Canada; e-mail: thack{at}sbrc.ca.

	ABSTRACT

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Purpose: Women with breast cancer were provided with an audiotape of their primary adjuvant treatment consultation, and the following patient outcomes were measured at 12 weeks postconsultation: perceived degree of information provision, audiotape satisfaction and use, communication satisfaction with oncologist, mood state, and cancer-specific quality of life.

Patients and Methods: Participants included 628 women newly diagnosed with breast cancer and 40 oncologists from six cancer centers in Canada. The patients were block randomized to one of four consultation groups: standard care control, not audiotaped; audiotaped, no audiotape given; audiotaped, patient given audiotape; and audiotaped, patient offered choice of receiving audiotape or not.

Results: Patients receiving the consultation audiotape had significantly better recall of having discussed side effects of treatment than patients who did not receive the audiotape. Audiotape benefit was not significantly related to patient satisfaction with communication, mood state, or quality of life at 12 weeks postconsultation, and was not significantly affected by choice of receiving the audiotape. Patients rated the audiotape intervention positively, with an average score of 83.9 of 100.

Conclusion: Audiotape provision benefits patients by facilitating their perception of being informed about treatment side effects, but does not significantly influence patient satisfaction with communication, mood state, or quality of life.

	INTRODUCTION

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EMPIRICAL INTEREST in patient-physician communication in the context of breast cancer is evidenced by the proliferation of aids designed to both facilitate a woman’s understanding of her illness and treatment, and assist her in participating more actively in the medical decision-making process. One of the most promising information and decision aids is the consultation audiotape. Consultation audiotapes offer patients a chance to have their memories refreshed, to hear information missed during the consultation, and to enhance their illness and treatment knowledge.^1–3 Consultation audiotapes also stimulate patients to request clarification of previously imparted information in subsequent consultations.⁴ Although some studies have found that consultation audiotapes produce greater information recall in comparison with nontape controls,^5–8 particularly for recall of diagnostic information by older patients,⁸ other studies have not demonstrated a differential benefit in recall when comparing the consultation audiotape with an individualized summary letter,⁹ or an added benefit when a consultation audiotape is a supplement to a consultation tailored to patients’ explicit information needs.¹⁰ Patients do, however, prefer consultation audiotapes to summary letters.⁹ Differences in these findings may be due, in part, to differences in recall assessment methods and the postconsultation time duration.

Although some studies demonstrate a positive impact of consultation audiotapes on psychological well-being,^2,11 others have shown no benefit.^6,12 Results of studies that address patient anxiety have been similarly mixed.^7,9 To date, only a nonsignificant relationship between audiotape provision and quality of life has been demonstrated.⁸

The primary purpose of this study was to examine systematically the impact of providing newly diagnosed breast cancer patients with an audiotape of their initial adjuvant treatment consultation. Outcomes of interest included perception of having been informed, satisfaction with communication with the oncologist, audiotape use and satisfaction, mood state, and quality of life. It was hypothesized that patients who received the audiotape would report being better informed, higher satisfaction, more positive mood, and better quality of life than would patients not furnished with the audiotape. The predictive value of patient involvement in treatment decision making was also examined to see if, as hypothesized, patients who listened to the audiotape and who preferred or assumed more involvement in treatment decision making would report being better informed, higher satisfaction, more positive mood, and better quality of life than patients who tended to defer to their oncologist about treatment-related decisions.

In the feasibility analysis for this study, providing consultation audiotapes significantly enhanced patients’ perceptions of being informed,¹³ yet inaccuracies of information recall were common. A previous study had found that despite some improvement in recall, consultation audiotapes resulted in recall of only 43.5% of the significant points covered by the oncologist.⁶ Although a certain degree of accurate recall may be necessary to enable patients to participate knowledgeably in making health care decisions, it is possible that the perception of having been provided with information may have a more significant impact on patient satisfaction and well-being than the accuracy of information recalled. In this study, the variable of interest was not the amount of information recalled, but rather the perception of having been informed.

This study addresses a gap in the audiotape research literature. Notably absent is an examination of the differential impact of giving patients the choice of receiving an audiotape or not. This omission stands out against two earlier studies in this area that found 20% to 25% of patients reported not feeling positive about having received an audiotape of their initial consultation.^2,3 We hypothesized that patients who choose the audiotape will listen to the audiotape more frequently, share it with more people, and report more positive outcome on the variables of interest than patients who receive the audiotape without choice. This hypothesis is supported by the findings of the pilot study for this larger effort,¹¹ and by studies that have demonstrated greater psychological well-being in women provided with choice of surgical treatment.^14–17

	PATIENTS AND METHODS

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Patient Sample
Eligible patients included those women with a confirmed diagnosis of breast cancer who presented to either a tertiary or community oncology clinic for their primary adjuvant treatment consultation. All patients were older than 18 years of age and were discerned to be free of any cognitive impairment that would disable them from providing informed consent. A total of 633 patients completed the protocol between November 1999 and March 2001. Patients were accrued from six cancer treatment facilities in four Canadian cities.

Forty medical and radiation oncologists (17 female; 23 male) agreed to have their patient consultations audiotaped. The majority of oncologists providing adjuvant therapy to patients with breast cancer in each of the participating cancer centers agreed to be involved in this study. Thirteen oncologists practiced in Vancouver, nine in Calgary, 11 in Edmonton, and seven in Winnipeg. The median number of patients accrued per oncologist was 12.5.

Study Design and Procedure
The study protocol was approved by the authoritative review committees for ethics in human subjects research at each of the participating institutions. All patients provided informed, written consent to participate in the study.

A double-blind research design was used in this randomized, controlled trial. Patients were block randomized (to ensure similar numbers of patients in each assigned group) to one of four consultation groups: standard care control, consultation not audiotaped (C); audiotaped, not given audiotape (T1); audiotaped, patient given audiotape (T2); and audiotaped, patient offered choice of receiving audiotape or not (T3).

Informed consent was obtained by the clinical research nurse before the consultations. Two consent forms were used to ensure that patients in the C group were not informed about the audiotape intervention. After having obtained consent, the patient demographic and illness form was completed, and the measure of patient preference for involvement in treatment decision making was administered.

Consultations were recorded simultaneously for all treatment (T) patients on two tape recorders placed at a location in the consultation room predetermined by the research nurse after discussion with the oncologist. The oncologist was responsible for pressing the record buttons on the recording equipment. To respect the privacy of each patient, the physical examination portion of the consultation was not recorded.

The clinical research nurse met with each patient immediately after the consultation to administer the postconsultation measures. Only after the postconsultation measures were completed did the research nurse reveal the patient’s treatment group assignment: T1, T2, or T3. In this manner, the research nurse was also blind to each treatment patient’s audiotape assignment until after the postconsultation measures were completed. The patients were then given the audiotape, not given the audiotape, or given a choice as to whether they wanted the audiotape or not, depending on their assigned treatment condition. Before each patient left the oncology clinic, the clinical research nurse gave each patient the follow-up questionnaires in a sealed envelope with the instruction not to open the envelope until contacted by the research nurse 12 weeks later. The research nurse contacted each patient by telephone 12 weeks postconsultation, and completed the questionnaires with the assistance of the patient.

Variables and Instruments
Immediately after the consultation, the clinical research nurse administered two measures. First, the Control Preferences Scale^18–20 was administered to assess the role that the patient actually played in decision making during the consultation. The scale is composed of five statements that correspond to active ("I prefer to make the decision about which treatment I will receive"; "I prefer to make the final decision about my treatment after seriously considering my doctor’s opinion"), collaborative ("I prefer that my doctor and I share responsibility for deciding which treatment is best for me"), and passive ("I prefer that my doctor makes the final decision about which treatment will be used, but seriously considers my opinion"; "I prefer to leave all decisions regarding treatment to my doctor") roles in decision making. Patients were asked to indicate the one statement that best represents them. The scale was modified slightly (ie, into past tense) for administration immediately after the consultation, and at the 12-week follow-up, to capture the patients’ assumed, rather than preferred, roles in decision making (eg, "I made. . . " replaced "I prefer to make. . . "; "My doctor and I shared. . . " replaced "I prefer that my doctor and I share. . . ").

The Patient Perception Scale, a nine-item measure of patient satisfaction with communication with the oncologist during the consultation,²¹ was administered next. This scale, reduced from the original 14-item version,²² includes items that assess the degree to which the patient feels the oncologist has adequately addressed the patient’s illness concerns, and the extent to which the oncologist has been patient-focused during the consultation. Each item is rated on a four-point scale, and the possible range of scores is 9 to 36, with 9 representing highest possible satisfaction.

At 12 weeks postconsultation, the following questionnaires were administered: Control Preferences Scale, actual role; Patient Perception Scale; Audiotape Use and Satisfaction Questionnaire; Informed Communication Scale; Profile of Mood States (POMS);²³ and Functional Assessment of Cancer Therapy (FACT-B).²⁴

The Audiotape Use and Satisfaction Questionnaire also was developed for use in this study, with modifications made to the instrument on the basis of pilot study findings. Questions assess the number of times the patient listened to a part (or all) of the consultation audiotape, the number of people who listened to the audiotape in addition to the patient, and the patient’s rating of the audiotape intervention: "On a scale of 0 to 100, where 0 = extreme dislike of the audiotape, 100 = extreme like of the audiotape, and 50 = neutral, do not dislike or like the audiotape, how do you rate the audiotape overall?"

The Informed Communication Scale was developed for this study, with modifications made after the pilot study. This scale is composed of five items that assess the degree to which patients recall having discussed the following categories of illness and treatment-related information with the oncologist during the consultation: treatment alternatives, side effects of treatment, likelihood of cure, extent of disease spread, and alternative forms of illness information. Each item is scored on a 5-point scale ranging from "1 = We definitely did not discuss" to "5 = We definitely did discuss," and the items can be summed to generate a total score. For this sample, Cronbach’s alpha at follow-up for the total score was 0.54.

Psychological adjustment was measured using the POMS,²³ a 65-item measure of general emotional disturbance. This measure is composed of seven subscales, including depression, anxiety, confusion, fatigue, anger, vigor, and friendliness. To more clearly differentiate between positive and negative affect, a POMS negative score was calculated by summing the five negative subscales.²⁵ Likewise, the two positive subscales were summed to yield a POMS positive score. For this sample, Cronbach’s alpha values at follow-up ranged from .31 (depression) to .77 (vigor) for the seven POMS subscales.

The FACT-B (version 4) is a 36-item self-report measure developed to assess the quality of life of women diagnosed with breast cancer.²⁴ The measure includes the 27-item FACT-G, which is composed of four primary subscales: physical well-being, social and family well-being, emotional well-being, and functional well-being, and nine additional items of concern specific to women with breast cancer. This measure has robust psychometric properties for both the total score and each of the subscale scores, and has been shown to be sensitive to meaningful clinical change.^26,27 In this study, Cronbach’s alpha for total score at follow-up was .82, whereas the subscale Cronbach’s alpha values ranged from .73 (functional well-being) to .84 (social and family well-being).

Data Analyses
Unix SAS (SAS/STAT User’s Guide, 1990, Version 6; SAS Institute, Cary, NC) V 8.2 software was used for all analyses. Descriptive statistics and correlation matrices were generated for all measures, and raw and standardized Cronbach’s alpha coefficients were generated for all psychological measures. Although the randomized controlled trial design should preclude differences of demography and treatment across the control and three treatment groups, these differences were assessed using analyses of variance tests as a precautionary check of the efficiency of the randomization procedure.

Linear contrast analyses were performed to assess the difference in means of scores on the dependent measures for the control and treatment groups for three preplanned comparisons: tape (assigned and chosen) versus no tape (assigned and standard care control); no tape (assigned) versus standard care control; and tape (assigned) versus tape (chosen). For all tests, P values less than .05 were considered statistically significant.

To examine the predictive relationship between patients’ preferred and assumed roles in treatment decision making and 12-week postconsultation outcome for those patients who listened to the consultation audiotape, a hierarchical regression analysis was performed. Demographic and treatment variables were forced into the model as the initial entry step. Six decisional role variables were created to allow for comparison of the active, collaborative, and passive roles at preconsultation (preferred), postconsultation (assumed), and 12 weeks postconsultation (assumed). Dummy variables were created with passive role as the reference category. A significance level of 0.05 was used for the final model.

	RESULTS

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Sample
Of the 785 eligible patients approached to participate in this study, 115 declined the offer, including five patients who planned to audiotape the consultation with their own recording equipment. Of the 670 remaining patients for whom the consent form was signed, 37 did not complete the study, and one person in the no tape (T1) group (who was mistakenly given a tape) was excluded, yielding a sample of 632 patients. Reasons for not completing the study included the following: patient wanted to withdraw after being assigned to the no audiotape (T1) group so that she could have an audiotape immediately (n = 3); patient either decided at follow-up that she did not want to continue in the study, or could not be contacted (n = 21); audiotaping equipment malfunctioned or was not set to record (n = 8); insufficient number of audiotape machines (n = 4); and patient changed her mind after having to wait too long to see her oncologist (n = 1).

The distribution of the sample across the treatment and control conditions of this study were as follows: C (n = 158); T1 (n = 147); T2 (n = 174); T3 (n = 153). Four of the T3 patients declined the audiotape. Because these patients were a small percentage of those patients offered a choice of receiving the audiotape (< 3%), they were removed from further analysis, yielding a final sample of 628 patients. The demographic and illness summary information for the sample is listed in Table 1. There were no statistically significant differences in the demographic or treatment variables across the C, T1, T2, and T3 groups, thereby confirming the random assignment of patients to groups.

Patients rated the audiotape intervention highly. Of the 196 patients who listened to the audiotape, 83 (42.4%) rated the intervention 100 out of a possible 100. There were 157 (80.1%) patients who rated the intervention 75 points or higher. This is in contrast to the one patient (0.5%) who rated the intervention lower than 25 points. Five (2.6%) patients rated the intervention 49 points or fewer. The mean audiotape favorableness rating was 83.9 of 100 (standard deviation [SD], 19.6), indicating highly positive regard for the intervention.

Effect of the Audiotape Intervention on 12-Week Postconsultation Outcome
Sample means and SDs for each outcome variable are listed in Table 2. A comparison of the two groups who received a copy of the audiotape (T2 and T3) with the two groups who did not receive the audiotape (T1 and C) revealed no significant differences in the following 12-week postconsultation outcomes: patient satisfaction with communication with the oncologist, mood state, or quality of life. An examination of the impact of the audiotaping process (C v T1) also produced no statistically significant differences on any of these outcomes. This latter test confirmed that benefits gained from the audiotape intervention are attributable to some process beyond having one’s consultation audiotaped. If this were not the case, a significant difference in outcome should have been found when comparing these two groups. The final comparison (ie, a test of the cognitive dissonance hypothesis) showed no significant difference in patient satisfaction, mood state, or quality of life between the two groups (T3 v T2) that received the audiotape.

Decisional Control
Patients’ preferred (preconsultation) and assumed (postconsultation and 12 weeks postconsultation) roles in treatment decision making are listed in Table 3. Slightly more than half of all patients (52.4%) preferred a collaborative role as they entered the consultation room. This percentage decreased to 40.6% after the consultation, when assumed roles were measured. The percentage of patients who endorsed an active role increased from preconsultation preferred role (23.6%) to postconsultation assumed role (34.8%). The pre- and postconsultation treatment role percentages were similar for patients who chose the passive role (24.0% v 24.6%).

	DISCUSSION

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The findings of this study suggest that consultation audiotapes are most useful to patients by fostering their perception of having been informed about treatment side effects. Because the side effects of treatments can be quite debilitating for patients, particularly for those undergoing chemotherapy (who often struggle with fatigue, nausea, and hair loss), consultation audiotapes may help patients prepare psychologically for the consequences of treatment in addition to helping them choose the most viable treatment option.

The benefits of consultation audiotapes may be most noticeable around the time of treatment planning as patients consider the various treatment alternatives available to them. In this study, the mean quality of life and mood state scores were consistent with published norms and previous studies.^26,28 Audiotape provision did not produce benefits to quality of life, mood state, or satisfaction with communication at 12 weeks postconsultation. A nonsignificant association between consultation audiotapes and quality of life has been reported previously.⁸ It is perhaps unreasonable to expect the provision of an audiotape to have a significant impact on psychological well-being, quality of life, or satisfaction a few months after the primary adjuvant treatment consultation. Outcome measurement in the pilot study for this effort was at 2, rather than 12 weeks postconsultation, and statistically significant associations between audiotape provision and perception of having been provided with information, and satisfaction with communication, were established. Future studies of the benefits of consultation audiotapes might best be served by assessing outcome more closely in time to when the most anticipated benefits are expected. For women with breast cancer, this may be during the 1- to 2-week postconsultation period when treatment decisions are most often finalized.

The current finding of no significant difference between the C and T1 groups demonstrates that the audiotaping process does not significantly affect outcome, thereby eliminating the need for future studies to include a group of patients who do not receive their consultation audiotapes. Statistical power may be enhanced in future studies by comparing a standard care control group to a group of patients who are given their consultation audiotapes (that is, eliminating the group of patients assigned to the no-tape condition [T1]). Eliminating this group of patients in future studies will also prevent having a subset of patients who feel frustrated because they did not receive a consultation audiotape despite having had their consultations recorded.

Despite support for the intervention by the majority of patients, just below 40% of patients did not listen to the audiotape. Several patients indicated during the follow-up interview that they had not yet listened to the audiotape because they did not feel emotionally prepared for the content. Other patients did not provide a reason for not listening to the tape, or simply stated that they felt no need to do so. Perhaps some of these patients had chosen their treatment during the consultation itself, or shortly thereafter, and did not want to create additional anxiety by listening to the audiotape and reconsidering their treatment choice.

These findings suggest that the degree to which a patient wants to be involved in treatment decision making is a significant indicator of outcome at follow-up. First, those patients who entered the consultation with a desire to share treatment decision making with their oncologists had better quality of life and mood state at 12 weeks postconsultation than did patients who preferred that their oncologists make all the treatment decisions on their behalf. Second, patients who indicated on exiting their consultation that they assumed an active role in treatment decision making during the consultation had similarly better outcome at follow-up. The findings suggest that, in addition to any benefits gained by listening to the consultation audiotape, psychological well-being is enhanced for those patients who enter the consultation with a desire for collaboration, and for those who exit the consultation with the belief they played an active role during the consultation. Previous studies of women with breast cancer support a significant inverse association between passive involvement in treatment decision making and psychologic adjustment.^29–31 Studies are needed to identify the ways that coping style or effort, including degree of preferred and actual involvement in decision making, is assisted or hindered by provision of consultation audiotapes. It may be that patients who use approach- rather than avoidance-based coping responses will benefit most from the intervention. Conversely, perhaps through education and support, patients who respond to their cancer diagnosis with avoidance-based coping have the most to gain from listening to their consultation audiotapes.

This study is the largest randomized, controlled trial to date that has examined the benefits of providing consultation audiotapes to cancer patients, and the findings highlight the support of the intervention by patients. The intervention is inexpensive, easy to implement, relatively unobtrusive to busy oncology clinics, and does not significantly alter the length of the consultations. Additional analysis of the intervention is necessary to more fully determine the range of benefits to be realized by patients, the type of patient that may benefit most, the most appropriate time to measure outcome, and the best way to incorporate consultation audiotaping into existing delivery modes of information provision and psychosocial care to women with breast cancer.

	AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

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The authors indicated no potential conflicts of interest.

	ACKNOWLEDGMENTS

 
We thank Ruth Bond for her statistical analysis of the data and valuable comments on the manuscript, and Betty-Lou Shoemaker, Sheryl Rosenhek, Linda Tkachuk, Kathy Cullihall, and Luella Sinha for gathering the data.

	NOTES

 
Supported by a research grant from the Canadian Breast Cancer Research Alliance. Thomas F. Hack is supported by a Dorothy J. Lamont Scientist Award from the National Cancer Institute of Canada (NCIC) and the Canadian Institutes of Health Research, and a Research Team Grant from the NCIC with funds from the Canadian Cancer Society (CCS) and the CCS/NCIC Sociobehavioral Cancer Research Network.

	REFERENCES

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Submitted December 26, 2002; accepted August 15, 2003.

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