Introduction In clinical practice, effective and clear communication is essential to the physician patient. Original Article

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1 412 Journal of Pain and Symptom Management Vol. 25 No. 5 May 2003 Original Article Breast Cancer Patient Perception of the Helpfulness of a Prompt Sheet Versus a General Information Sheet During Outpatient Consultation: A Randomized, Controlled Trial Eduardo Bruera, MD, Catherine Sweeney, MB, Jie Willey, RN, MSN, J. Lynn Palmer, PhD, Susanne Tolley, RN, Marguerite Rosales, MD, and Carla Ripamonti, MD Departments of Symptom Control and Palliative Care (E.B., C.S., J.W., J.L.P., S.T.) and Breast Medical Oncology (M.R.), The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA; and Rehabilitation and Palliative Care Division (C.R.), National Cancer Institute, Milan, Italy Abstract The purpose of this study was to determine the helpfulness of a prompt sheet versus a general information sheet for patient communication with physicians. Sixty women with breast cancer attending their first outpatient consultation with a breast medical oncologist were randomized to receive either a prompt sheet (PS) or a general information (GI) sheet regarding breast cancer. Analysis of the results found that helpfulness of the written material was rated higher in the PS group (8.5 2) than the GI group ( ), P The mean score of helpfulness in communicating with physicians was and , respectively, P There were no significant differences between the groups in the average total number of questions asked by the patients or average physician or patient speaking time. We conclude that a disease-specific prompt sheet provided before medical encounters may assist in communication between patients and physicians. J Pain Symptom Manage 2003;25: U.S. Cancer Pain Relief Committee. Published by Elsevier. All rights reserved. Key Words Breast cancer, prompt sheet, communication Introduction In clinical practice, effective and clear communication is essential to the physician patient Address reprint requests to: Eduardo Bruera, MD, Department of Palliative Care and Rehabilitation Medicine, Box 8, U.T. M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, Texas 77030, USA. Accepted for publication: July 16, relationship. 1 Moreover, better communication can translate into improved patient satisfaction. 2 Given the increased incidence of breast cancer over the last few years and the estimated 192,200 new cases of breast cancer expected in the United States in 2001, 3 the type and quality of communication between breast cancer patients and their physicians will impact many people. Improved communication will not only affect the patients quality of care, mechanisms for coping, and compliance with treatments but 2003 U.S. Cancer Pain Relief Committee /03/$ see front matter Published by Elsevier. All rights reserved. doi: /s (02)

2 Vol. 25 No. 5 May 2003 Breast Cancer Prompt Sheet 413 will also likely affect the success of individual physicians and health care facilities. Several approaches have been proposed for improving communication between patients and physicians, including giving patients a letter summarizing the consultation 4 and giving patients a tape recording of the consultation. 5 8 In a recent randomized controlled trial, 8 we found that giving patients an audiocassette in addition to written communication significantly increased patient satisfaction with an oncology clinic and significantly improved recall of the information received during the consultation. Audiocassettes and written information are currently used regularly during patient visits in the Department of Palliative Care and Rehabilitation Medicine at our institution. However, one of the limitations of this approach is that although patients receive reinforcement of discussions that take place during the clinic visit, the approach does not ensure that patients ask those questions that are of greatest concern to them. Two preliminary studies by an Australian group suggest that giving patients prompt sheets with suggested questions might be helpful in enhancing communication during consultations. 9,10 Butow et al. randomized 142 cancer patients to receive a question prompt sheet (PS) or a general information sheet (GI). 9 They found that the prompt sheet did not influence the total number of questions asked and the duration of patient talk. Brown et al. randomized 60 cancer patients to receive either a PS or a standard consultation. 10 They observed an increased number of questions asked in the PS group. Both of these studies assessed only global satisfaction with the clinic instead of specifically assessing the prompt sheet. Their studies found extremely high level of global satisfaction in both intervention and control groups and there was no significant difference. 9,10 The authors of one of the of the studies concluded that the prompt sheet had limited value. 9 Despite the literature showing that global satisfaction is usually rated very highly, 9 11 there is evidence that communication between patients and doctors can directly affect patient satisfaction outcomes. Unfortunately, patient expectations are frequently not met and patients are often not satisfied with information received Communication may be better when patients are able to ask their most meaningful questions rather than just more questions. In the current study, we randomized patients with breast cancer to receive either a prompt sheet or a general information sheet regarding breast cancer before their consultation with breast medical oncologists. Our primary goal was to specifically determine how helpful patients found the prompt sheet as compared to the general information sheet. Methods Patient Selection The study was performed in the Breast Center at the University of Texas M.D. Anderson Cancer Center. To be included in the study, patients had to have pathologically confirmed breast cancer, be 18 years old, and be attending their first outpatient consultation with a breast medical oncologist. They also had to have a normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits, be able to communicate in English, and have signed a written informed consent form. When the research nurse identified a potentially eligible patient, the attending physician was informed and asked to give verbal consent for the patient s participation in the study. Patients then provided written consent to participate in the study and were randomly given an envelope by the research nurse while they waited for their visit. The envelope contained written information of either a PS or a GI regarding breast cancer. The research nurse was blinded as to the patient s randomization. Clinicians who saw the patients in their clinic were not instructed to respond to neither the PS nor the GI. To prevent patient bias, we did not disclose which of the 2 interventions we thought would be most likely to improve communication. Our consent form was written to reflect this need, which was disclosed to the patients. Design of Prompt Sheet The initial draft for the prompt sheet was based on previous studies 9,10,13 and other suggestions. 14 Modifications included the addition of extra questions, some minor changes based on the audiocassette study results 8 and the clinical experience of the faculty in the Department of Palliative Care and Rehabilitation Medicine and the Department of Breast Medi-

3 414 Bruera et al. Vol. 25 No. 5 May 2003 cal Oncology at the M. D. Anderson Cancer Center. The prompt sheet contained 22 breast cancer diagnosis, treatment, and prognosis-related questions. In addition, space for new questions was added. After discussions with the co-investigators and the faculty of the Department of Breast Medical Oncology, the content was once again modified, and a final prompt sheet was designed (Appendix 1). Design of General Information Sheet The information sheet is enclosed as Appendix 2. This sheet was created by the faculty and staff of the Breast Center, the University of Texas M. D. Anderson Cancer Center. The general information sheet was summarized so as to be able to be read comfortably during the period of time patients and families wait before being seen by one of the physicians and/or nurses. Based on the experience of the breast cancer oncologists and nurses we summarized the area that is usually considered of highest relevance for them from their booklet. 17,18 Procedures The consultation between the patient and the physician was recorded on an audiocassette. At the end of the visit, the research nurse (not present during the consultation and blinded to the type of written material given) gave the patient a questionnaire for completion that dealt with aspects of the consultation and information package (Appendix 3). A physician evaluation form was presented to the physician who was also blinded as to the type of written material given at the time. The physician evaluation form consisted of 2 statements: 1) Overall, I am satisfied with the way I was able to communicate with my patient (assessed by a numerical rating scale of 0 to 10); and 2) The duration of visit compared to my expectation (a multiple choice was given to determine whether the visit was much longer, a little longer, no longer or shorter, a little shorter, or much shorter than expected). The following information was collected from the audiocassette by the research nurse: 1) total duration of the visit in minutes; 2) amount of time during which the physician spoke; 3) amount of time during which the patient spoke; 4) total number of questions asked by the patient and relatives; and 5) the category of each question asked, namely, diagnosis, treatment, prognosis, or other. Finally, the research nurse reviewed the patient s chart and collected information regarding diagnosis, demographics, and other patient characteristics. Statistical Considerations The primary outcome measures included patient rating of helpfulness of the information package and satisfaction with communication during the clinic visit. Our hypothesis was that patients receiving the prompt sheet would show higher helpfulness and satisfaction ratings than patients who received the general information sheet. To test these hypotheses, analyses of variance models were tested using patient satisfaction scores as dependent variables and treatment group as a predictor. Differences between groups in demographic variables were tested to determine if the variables should be added as covariates in the models. Secondary outcomes, such as duration of the clinic visit and the number of questions asked were evaluated in a similar fashion. Results Of 132 patients screened for the study, 60 women with breast cancer were enrolled. Thirty women received the prompt sheet (PS) and 30 received the general information sheet (GI). Figure 1 summarizes the patient accrual process. Fig. 1. Patient Accrual. *Twenty-seven patients did not speak English, 7 had no pathologic confirmation of breast cancer, 1 had history of anxiety, 16 patients previously treated at M.D. Anderson Cancer Center, 9 patients were not consented due to time constraints.

4 Vol. 25 No. 5 May 2003 Breast Cancer Prompt Sheet 415 Characteristic Table 1 Demographic and Clinical Characteristics of Patients No. of Patients in GI Group (%) No. of Patients in PS Group (%) Total Patients (%) Overall 30 (50) 30 (50) 60 (100) Mean Age, years (range) 54 (37 80) 53.4 (26 80) (26 80) Race/Ethnicity Black 1 (3) 0 (0) 1 (2) White 26 (87) 28 (93) 54 (90) Asian 1 (3) 1 (3) 2 (3) Hispanic 2 (7) 1 (3) 3 (5) Educational Level Under 12th grade 1 (3) 1 (3) 2 (3) High school graduate 10 (33) 9 (30) 19 (32) College or higher 19 (64) 20 (67) 39 (65) Occupation Professional 10 (33) 8 (27) 18 (30) Business 6 (20) 4 (13) 10 (17) Clerk and secretary 6 (20) 8 (27) 14 (23) Labor 1 (3) 0 (0) 1 (2) Homemaker 7 (24) 10 (33) 17 (28) Martial Status Married 24 (80) 19 (63) 43 (72) Single 1 (3) 2 (7) 3 (5) Divorced/Separated 4 (14) 5 (17) 9 (15) Widowed 1 (3) 4 (13) 5 (8) House Income Less than $50, (37) 11 (37) 22 (37) $50, , (50) 12 (40) 27 (45) Above $100,000 1 (3) 1 (3) 2 (3) Declined to answer 3 (10) 6 (20) 9 (15) Current Stage Local/regional 20 (67) 17 (57) 37 (62) Metastatic 10 (33) 13 (43) 23 (38) Time Since Diagnosis 2 months 15 (50) 15 (50) 30 (50) 2 months 15 (50) 15 (50) 30 (50) Prior Treatment Surgery 15 (50) 9 (30) 24 (40) Systemic therapy 1 (3.3) 0 1 (1.6) None 3 (10) 12 (40) 15 (25) Surgery radiation 1 (3.3) 0 1 (1.6) Surgery systemic therapy 3 (10) 3 (10) 6 (10) Radiation systemic therapy 1 (3.3) 0 1 (1.6) Surgery radiation systemic therapy 6 (20) 6 (20) 12 (20) Table 1 shows the demographic and clinical characteristics of the patients. Their mean age was 54 years (range years); most patients in both groups were white, were married, and had some college or completed college degree. Twenty-eight (47%) of 60 patients were professionals or businesswomen, and 17 (28%) were homemakers. Twenty-nine patients (48%) reported household income more than $50,000. Thirty-seven patients (62%) had local or regional disease. The time since diagnosis of breast cancer was at least 2 months for 30 patients (50%). No statistically significant differences were found between the groups for demographic variables. Table 2 reports the results of the patient questionnaire. The mean overall helpfulness rating (a numerical rating scale 0 to 10) of the written material was significantly higher in the PS group (8.5) than GI group (6.2), P The mean helpfulness of the written material in communicating with physicians was 7.9 for the PS group and 5.7 for GI group, P Overall satisfaction with the consultation, satisfaction with the communication with the doctor, and satisfaction with the ability of the doctor to answer the patients questions were very high in both groups (no significant differences).

5 416 Bruera et al. Vol. 25 No. 5 May 2003 Table 2 Results of Patient Satisfaction Survey Variable Rating by Patients in GI Group, mean (SD) Rating by Patients in PS Group, mean (SD) P value Helpfulness of written material 6.20 (3.65) a 8.47 (2.08) Written material helped to communicate with the doctor 5.70 (3.79) 7.90 (2.37) Overall satisfaction of communication with the doctor 9.07 (1.33) 9.23 (1.33) Satisfaction with the consult 9.03 (1.67) 8.70 (1.62) Doctor was able to answer all the questions 9.30 (1.39) 8.90 (1.72) Will use similar written material in the future 7.87 (3.03) 8.93 (1.68) a 0 completely disagree; 10 completely agree. Table 3 reports the results of consultation recordings. Only the number of questions on diagnosis differed between the two groups: 2.5 (PS) group vs. 1.4 (GI) group, P The average total number of questions asked by the patients was not significantly different between the 2 groups and the average physician and patients speaking times were also not significantly different. All other differences between the groups were not statistically significant. Patients in both groups asked more questions related to treatment (5.08 for the PS group, 6.66 for the GI group) than to any other category, and they both asked fewest prognosis-related questions ( and , respectively). The physicians were blinded with respect to the written material received by the patients and reported no difference in satisfaction with the way they were able to communicate with their patients (9.4 for the PS group vs. 9.1 for the GI group). In 40 cases (67%), the physician estimated that the consultation duration was not longer or shorter than expected, and this result was not significantly different between the PS group and the GI group. Discussion In this randomized, controlled trial we found that the administration of a prompt sheet had significant effects on patient helpfulness ratings of the written material provided and of communication with the doctor when compared to the general information sheet. The prompt sheet was perceived by patients as helpful for communication without significantly increasing the length of the physician or patient speaking time or the total number of questions asked during the visit. Our findings suggest that these patients were able to ask questions that better address their main concerns rather than simply asking more questions. One possible alternative explanation is that although patients perceived the material to be helpful, communication was not more effective. This question can be resolved in future studies by asking beforehand patient s critical questions and monitoring if they were actively addressed during the interview. In our study, the fact that speaking times were not different between the 2 groups suggests that using a prompt sheet in regular clinical care can improve communication quality without increasing cost of care. Overall patient Table 3 Results of Audiocassette Recording Variable GI Group, mean (SD) PS Group, mean (SD) P value Consultation duration in minutes (47) (53) Number of questions asked by the patient 8.65 (5.28) (7.46) Minutes the patient spoke 5.58 (5.09) 5.45 (6.12) Minutes the doctor spoke (20.62) (21.42) Number of questions on diagnosis 1.38 (1.36) 2.45 (1.97) Number of questions on treatment 5.08 (3.50) 6.66 (4.56) Number of questions on prognosis 0.62 (1.02) 1.03 (1.21) Number of questions on other issues 4.00 (3.07) 4.60 (3.90) 0.519

6 Vol. 25 No. 5 May 2003 Breast Cancer Prompt Sheet 417 satisfaction with the clinic was extremely high and there was no significant difference between the 2 groups. The general information sheet used in the study was an established preexisting tool developed and used regularly by breast cancer specialists in our institution. Median satisfaction and helpfulness ratings in the control group indicate that patients found it useful. When Brown et al. studied the use of a prompt sheet during a standard consultation in a randomized controlled trial of 60 patients with heterogeneous cancers, the prompt sheet significantly increased the total number of questions asked and the number of questions asked regarding tests and treatment. 10 This study may have been biased as enrolled patients had higher levels of education than the general population. Butow et al. did not find any increase in the number of questions asked by the prompt sheet group. 9 The addition of one-on-one intensive coaching with a psychologist before the initial oncology consulta tion during which prompt sheet was used did not further increase the number of questions asked. The authors also tested global satisfaction in their study and found no significant difference between the 2 groups. In a recent study patients who received a prompt sheet had longer consultations and asked more questions as compared to those who did not. 15 The consultation duration was decreased when oncologists specifically addressed the prompt sheet. Our results are consistent with others in the literature in that satisfaction did not correlate well with the number of questions or speaking times. 9,10 However, the effect of the use of a prompt sheet on duration of the consultation needs to be clarified in future research. If researchers in other patient population confirm our findings, clinicians will be able to administer disease-specific prompt sheets to their patients without fear that this will result in excessive demands on their clinical time. Patients in our study asked a mean of 9 10 questions per consultation, similar to the 8 11 questions observed by Brown et al. 10 Patients who were given the prompt sheet asked significantly more questions about diagnosis than patients who were given the general information sheet. Other studies of prompt sheet use have produced similar findings. 9,10 A limitation of our study is that the design did not allow for testing of recall of information by patients. However, recall of information was not the main purpose as patients may have excellent recall of information that is not of relevance to them. The purpose of the prompt sheet was to help patients and their family to formulate questions that were relevant to them. A recent study has suggested that patients who have a prompt sheet addressed by their oncologist recall significantly more information and have less anxiety than those who have been given a prompt sheet alone. 15 This area should be clarified through further research. Future research should address improving patient information regarding diagnosis that could result in increased satisfaction with communication. The lack of questions about potentially difficult issues such as prognosis in both groups (median of 0 to 1 question asked) was probably due to the fact that we were studying a first consultation and its focus was mostly treatment decisions. It is likely that the types of questions asked during follow up visits or by patients with more advanced disease would be different than those found in our study. Therefore, these issues should also be addressed in future research. In previously published studies, the total number of questions asked seems to be less for male patients than female patients. 9,16 Butow et al. reported a mean of questions asked by women as compared to questions asked by men (P ). The duration of communication was also shorter for male patients. 9 Since men s question asking behavior appears to be lower than women s, future research should also address whether or not a prompt sheet can increase question asking by male patients and improve men s ability to plan their questions. We conclude that a disease specific prompt sheet provided before medical encounters is perceived to significantly assist in communications between patients and doctors and may not increase the overall number of questions asked or the duration of the physician or patient speaking time. Our findings need to be reproduced in patients with other chronically illness since similar beneficial results can likely be derived in these patient populations.

7 418 Bruera et al. Vol. 25 No. 5 May 2003 References 1. Morrow GR, Hoagland AC, Carpenter PJ. Improving physician-patient communications in cancer treatment. Psychosocial Oncology 1983;1/2: Kaplan SH, Ware J. The patient s role in health care and quality assessment. In: Goldfield N, Nash DB, eds. Providing quality care. Ann Arbor: Health Administration Press, 1995: Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics Cancer J Clin 2001;51: Damion D, Tattersall MHN. Letters to patients: improving communication in cancer care. Lancet 1991;338: Dunn SM, Butow PN, Tattersall MHN, et al. General information tapes inhibit recall of the cancer consultation. J Clin Oncol 1993;11: Hogbin B, Fallowfield L. Getting it taped: the bad news consultation with cancer patients. Br J Hosp Med 1989;41: Tattersall MHN, Butow PN, Griffin AM, Dunn SM. The take home message: patients prefer consultation audiotapes to summary letters. J Clin Oncol 1994;12: Bruera E, Pituskin E, Calder K, et al. The addition of an audiocassette recording of a consultation to written recommendations for patients with advanced cancer: a randomized, controlled trial. Cancer 1999;86: Butow PN, Dunn SM, Tattersall MHN, Jones QJ. Patient participation in the cancer consultation: evaluation of a question prompt sheet. Ann Oncol 1994;5: Brown R, Butow PN, Boyer MJ, Tattersall MHN. Promoting patient participation in the cancer consultation: evaluation of a prompt sheet and coaching in question asking. Br J Cancer 1999;80: Kravita RL, Cope DW, Bhrany V, Leake B. Internal medicine patients expectations for care during office visit. J General Inter Med 1994;9: Ong LM, DeHaes JC, Hoos AM, Lammes FB. Doctor-patient communication: a review of the literature. Soc Sci Med 1995;40: Ley P. Communication with patients: improving communication, satisfaction and compliance. London: Chapman and Hall, Kutner JS, Steiner JF, Corbett KK, et al. Information needs in terminal illness. Soc Sci Med 1999;48: Brown RF, Butow PN, Dunn SM, Tattersall MH. Promoting patient participation and shortening cancer consultations: a randomized controlled trial. Br J Cancer 2001;85: Hall JA, Roter DL. Patient gender and communication with physicians: results of a communitybased study. Women s Health 1995:1: Friedewald V, Buzdar AU, Bokulich M. Ask the doctor: breast cancer. Kansas City, Missouri: Andrews and McMeel, Singletary SE, Judkins AF. Breast cancer: myths and facts. New York: PRR, Inc., Appendix 1 Prompt Sheet for Breast Cancer Consultation Please check the questions that you are interested in asking your doctor. 1. What is the type and stage of my cancer? 2. Has my cancer spread? 3. If it has spread, where has it spread to and which test showed that? 4. What treatment options are available for me? 5. Do I need any more tests or procedures before my treatment? 6. How long will I be in this treatment? 7. What is the percentage of success of this treatment for the other patients? 8. How often do I need to come in to see the doctor? 9. Can I get my treatment at my local doctor s office? 10. Will the treatment have any side effects or complications? 11. What symptoms should I be alert for (i.e., fever, pain, etc.) and what should I do about these symptoms? 12. What should I do or not do when I am getting treatment, such as changing eating habits, drinking, exercising, sexual activity, and birth control? 13. If I am taking alternative medicine, can I still continue (herbs, natural foods, massage and chiropractic therapy, etc.)? 14. How and when will I know whether the treatment is working? 15. If we get rid of the cancer, what are the chances the cancer will come back? 16. What options do I have if this treatment does not work? 17. Will my family be affected by my cancer/treatment? 18. Will the treatment affect my ability to work or perform other activities? 19. Will my children have higher risk of getting cancer? 20. Can I get information on my cancer through the Internet? 21. Are there services available to help me to cope with my illness? 22. If I participate in the clinical trial will the drug company cover my treatment cost or will Medicare/Medicaid or health insurance cover the cost?

8 Vol. 25 No. 5 May 2003 Breast Cancer Prompt Sheet 419 Appendix 2 General Information Sheet for Breast Cancer Consultation General Information of Breast Cancer Treatment When a woman has been diagnosed with breast cancer, she and her team of doctors develop a comprehensive treatment plan. The plan outlines the type of surgery that will be used to remove the tumor and any additional therapy, such as radiation therapy, chemotherapy, or hormonal therapy, that will be given. There are many different types of breast cancer, so the treatment is not the same for every woman. The treatment depends upon many factors including the type of cancer cells, how much the disease has spread, and the size of the tumor. About Chemotherapy In chemotherapy, drugs are used to kill cancer cells. Chemotherapy drugs can be given by mouth, by injection, or by infusion into a vein. Chemotherapy drugs can be given in a hospital, a clinic, or a doctor s office. Most patients are able to go home between treatments and during the recovery period. Because chemotherapy affects any cell that is in the process of multiplying, normal cells may also be damaged. Chemotherapy involves the person s entire body and produces a number of side effects. One of the most feared side effects is nausea and vomiting. Fortunately, very effective medications have been developed to reduce the severity of these effects and even prevent them altogether in some patients. Other common side effects are hair loss, mouth sores, fatigue and increased chance of infections. Most side effects are temporary and go away after the chemotherapy is finished. Often chemotherapy is given with surgery, radiation therapy, or both to decrease the chance that the cancer will recur. This is done when there is a high risk that tumor cells have spread into the blood or lymph vessels. Chemotherapy given for this purpose is called adjuvant therapy. In some cases, chemotherapy is given before surgery to attempt to reduce the size of the lump and therefore make breast-conserving therapy possible. This type of chemotherapy is called neoadjuvant therapy. About Hormonal Therapy In hormonal therapy, antiestrogen drugs are used to block the effects of hormones that promote tumor growth. Estrogen is a hormone that sometimes promotes the growth of breast cancer. Hormonal therapy affects the entire body. It can cause hot flashes, excessive perspiration, vaginal itching or bleeding, temporary weight gain, nausea, and occasional depression. Not all breast cancers are sensitive to estrogen. To determine if a tumor is sensitive to estrogen, an estrogen receptor assay (also called an estrogen receptor test or ER test) is performed on cancer tissue removed at the time of surgery: a tumor sensitive to estrogen is estrogen receptor-positive, a tumor that is not sensitive is estrogen receptor-negative. Estrogen receptor positive cancers are generally more likely to respond to hormonal therapy; hormonal therapy is usually not used for estrogen receptor-negative cancers. Please circle the number that describes your feelings: Appendix 3 Patient Satisfaction Assessment 1. I am satisfied with the consult Extremely satisfied 2. The doctor was able to answer all my questions Extremely satisfied 3. The information package was helpful Extremely helpful 4. I believe the information package helped me to communicate with my doctor Extremely well 5. I will use a similar information package or write questions down before I see my doctor in the future Completely disagree Completely agree 6. Overall, I am satisfied with the way I was able to communicate with the doctor Extremely well