A Randomized Controlled Trial of a Standardized Educational Intervention for Patients with Cancer Pain

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1 Vol. 40 No. 1 July 2010 Journal of Pain and Symptom Management 49 Original Article A Randomized Controlled Trial of a Standardized Educational Intervention for Patients with Cancer Pain Melanie R. Lovell, MBBS, FRACP, FAChPM, Peta M. Forder, BSc, MPH, MBioS, Martin R. Stockler, MBBS, FRACP, MClin Epi, Phyllis Butow, BA, MPH, MClin Psych, PhD, Esther M. Briganti, MBBS, MClin Epi, PhD, FRACP, Richard Chye, MBBS, FRACP, FFPMANZCA, FAChPM, David Goldstein, MRCP(UK), FRACP, and Frances M. Boyle, MBBS, PhD, FRACP Greenwich Hospital (M.R.L.), Greenwich; NHMRC Clinical Trials Centre (P.M.F., M.R.S.), and Medical Psychology Research Unit (P.B.), School of Psychology, University of Sydney, Camperdown; Sacred Heart Centre (R.C.), Darlinghurst; Department of Medical Oncology (D.G.), Prince of Wales Hospital, Randwick; Patricia Ritchie Centre for Cancer Care and Research (F.M.B.), Mater Hospital, North Sydney, New South Wales; and Epworth Hospital (E.M.B.), Richmond, Victoria, Australia Abstract Context. Published literature has not defined the effectiveness of standardized educational tools that can be self-administered in the general oncology population with pain. Objectives. We sought to determine if an educational intervention consisting of a video and/or booklet for adults with cancer pain could improve knowledge and attitudes about cancer pain management, pain levels, pain interference, anxiety, quality of life, and analgesic use. Methods. Eligible participants had advanced cancer, a pain score $2 of 10 in the last week, English proficiency, an estimated prognosis of more than one month, and were receiving outpatient cancer treatment at participating hospitals. Participants completed baseline assessments and then were randomly allocated to receive a booklet, a video, both, or neither, in addition to standard care. Outcome measures at two and four weeks included the Barriers Questionnaire (BQ), Brief Pain Inventory, Global Quality of Life Scale, and Hospital Anxiety and Depression Scale. Adequacy of analgesia and severity of pain were assessed with the Pain Management Index and a daily pain diary. Results. One hundred fifty-eight participants were recruited from 21 sites over 42 months. Baseline mean barriers scores were lower than reported in previous Australian studies at 1.33 (standard deviation: 0.92). Mean average pain and worst pain scores improved significantly in patients receiving both the video and booklet This study was supported by Friends of the Mater Foundation and the Clinical Trials Partnership, jointly sponsored by the Cancer Institute NSW and the NHMRC Clinical Trials Centre. Address correspondence to: Melanie R. Lovell, MBBS, FRACP, FAChPM, Greenwich Hospital, P.O. Box Ó 2010 U.S. Cancer Pain Relief Committee Published by Elsevier Inc. All rights reserved. 5084, Greenwich, New South Wales 2065, Australia. MLovell@nsccahs.health.nsw.gov.au Accepted for publication: December 14, /$esee front matter doi: /j.jpainsymman

2 50 Lovell et al. Vol. 40 No. 1 July 2010 by 1.17 (standard error [SE]: 0.51, P ¼ 0.02) and 1.12 (SE: 0.57, P ¼ 0.05), respectively, on a 0e10 scale. The addiction subscale of the BQ score was improved by 0.44 (SE: 0.19) for participants receiving any part of the intervention (P ¼ 0.03). Conclusion. Provision of a video and/or booklet for people with cancer pain was a feasible and effective adjunct to the management of cancer pain. J Pain Symptom Manage 2010;40:49e59. Ó 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. Key Words Patient education, randomized controlled trial, cancer pain Introduction Pain is experienced by 53% of patients with cancer at any stage of disease and one-third of these patients grade it as moderate or severe. 1,2 People with unrelieved severe pain have reduced function, quality of life (QOL), 3 and increased levels of anxiety and depression. 4e7 Pain also has a significant impact on caregivers. 8e11 Despite a plethora of available therapeutic strategies, there is evidence that cancer pain is frequently undertreated. 12,13 Some of this is because of concerns, such as fear of addiction, which have led to suboptimal use of opioids. 12,14 Such concerns may be underrecognized or poorly addressed by health care providers and might usefully be included in patient education materials. Methods of information-giving in cancer shown to be effective in a systematic review of randomized controlled trials include written information, audiotapes, audiovisual material, and structured targeted information sessions. 15 Furthermore, different modalities were suitable for different coping styles and different preferences. Previous research has demonstrated some benefits of educational interventions for people with pain and cancer. 16e25 The interventions investigated were all nurse administered, which has significant resource Published literature has not defined the effectiveness of standardized tools, which can be self-administered in the general oncology population. Given the prevalence, severity, and morbidity of cancer pain, a widely available effective educational tool is necessary for people to improve pain knowledge, attitudes, and ability to be involved in their own pain management. In implications. 16,17,19e23,26 Australia, where patients or health professionals may need to travel vast distances for consultations, there is a need for such a tool, which does not depend on health professional expertise. In this study, our aim was to determine whether an educational intervention consisting of a video and/or a booklet designed for people with advanced cancer and pain could improve their knowledge about and attitudes to pain, their pain levels, pain interference, pain management, anxiety, and QOL. Methods Settings and Participants We recruited participants through oncology and radiation oncology outpatient clinics, palliative care clinics, and community services at 21 participating centers in New South Wales, Australia. Ethics review committees gave approval at each participating center. The trial was registered with the Australian Clinical Trials Registry (number ACTRNO ). Outpatients with advanced cancer were eligible if they had cancer pain scores $2 of10in the last week, English proficiency, a life expectancy of more than one month to allow for measurement of outcomes, were receiving cancer treatment at participating hospitals, older than 18 years, and had given signed informed consent. Exclusion criteria were cognitive, visual or hearing impairment, or previous exposure to the education materials. Design Participants were randomly allocated to one of four treatment arms: 1) standard care only,

3 Vol. 40 No. 1 July 2010 Standardized Cancer Pain Education for Patients 51 involving no pain education additional to that routinely provided by nurses or physicians, 2) standard care plus a booklet, 3) standard care plus a video, or 4) standard care plus a booklet and video. Intervention The authors developed the booklet and video using information from focus groups of people with advanced cancer and their caregivers 27 and from evidence-based information about the effective management of cancer pain. 28e30 The video depicts patients, a caregiver, and health professionals talking about cancer pain and its management. The booklet, published by the New South Wales Cancer Council in their Understanding Cancer series, contains text and cartoons about pain and its management and was written for an audience with a reading age of 12 years (typical of the general population). It is available at au/html/patientsfamiliesfriends/livingwith cancer/cancerpain/downloads/overcoming_ cancer_pain.pdf. Data Collection The demographic and clinical variables collected included age, sex, type of tumor, education level, marital status, hospital setting (rural, regional, or urban), and whether English was the first language. Outcome measures were as follows: 1. Barriers Questionnaire (BQ), 14 which has been validated in Australian subjects. 12 This 27-item self-report questionnaire was designed to measure the extent to which a patient s concerns present a barrier to adequate analgesia. Subscale scores are based on the average of the relevant item questions, and therefore can range from 0 (low barriers) to 5 (high barriers). The total barrier score is the average of all 27-item responses. 2. Wisconsin Brief Pain Inventory (BPI). The BPI questionnaire includes items regarding the presence of pain, site of pain, severity on average, now and at its worst in the last month on a 0e10 scale, current medication and percentage response, character of pain, and degree of interference. 31 The interference scale of the questionnaire was modified to reflect the validated questionnaire from a previous Australian study, using a 0-4 point scale rather than the 0e10 of the original Pain Management Index (PMI). This is a measure of adequacy of analgesia by comparing the most potent analgesic used by a participant relative to the level of their reported pain. Analgesic strength is categorized as 0 (no analgesic), 1 (paracetamol [acetaminophen] or nonsteroidal anti-inflammatory drug), 2 ( weak opioid), or 3 ( strong opioid). We categorized pain into four levels according to the worst pain item from the BPI (scored from 0 to 10): 0 (no pain ¼ 0), 1 (mild pain ¼ 1e4), 2 (moderate pain ¼ 5e6), and 3 (severe pain ¼ 7e10). The PMI is calculated by subtracting the pain score from the analgesic score. A negative result indicates inadequate analgesia, and zero or positive value indicated adequate analgesia Uniscale for Global Quality of Life, 33 which is a well-established measure of QOL. 5. Hospital Anxiety and Depression Scale (HADS), which is a well-validated and widely used questionnaire for assessing anxiety and depression in people with medical illnesses We asked participants to give global assessments of the intervention by answering the following questions with a response of yes or no: Did you find the education package helpful? Do you feel more able to take part in your own pain management? 7. Patients completed a pain diary recording their average pain (numeric rating scale: 0e10) daily for the four-week study period, and this was correlated with the BPI average pain scores. Measures were collected two and four weeks after randomization. Participants who had not seen the video or booklet were then offered the chance to do so. Procedure Clinicians approached potential participants in medical oncology, radiation oncology, and

4 52 Lovell et al. Vol. 40 No. 1 July 2010 palliative care clinics; written informed consent was gained from those interested by a research nurse. Participants were randomized centrally by telephone according to random number tables to one of the four treatment groups. It was noted that 32 of the first 140 participants did not complete baseline questionnaires, potentially resulting in differences in group sizes. The procedure was, therefore, tightened to ensure that all baseline questionnaires were completed before randomization for the remaining 77 participants. This was done to reduce the potential risk of bias caused by more people potentially electing not to commence the trial if they were allocated to the control condition, and to improve compliance and data quality. Participants in the intervention arms were given the booklet, video, or both, for later use. Given the nature of the intervention, blinding was not considered practical. Statistical Considerations The planned sample size of 200 was designed to provide 80% power to detect a minimum clinically relevant difference of 0.5 units on the BQ (0e5 scale) with a standard deviation (SD) of 0.8, two-sided Type I error rate (a) of 5%, and a 10% allowance for incomplete data. Analysis was restricted to randomized participants who provided data at baseline and at least one other time point postrandomization. The study was initially conceived as a 2 2 factorial design, but we decided to analyze it as a four-group parallel study because an interaction effect was found between the video and booklet. All analyses were carried out with the SAS program (SAS Institute Inc. NC) and were by intention to treat. All reported P-values and confidence intervals (CIs) are two-sided. No adjustments were made to account for multiple comparisons. To determine the average difference between the intervention group and standard care, generalized linear models using generalized estimating equations with an exchangeable correlation structure and robust variance estimators were used for both continuous and binary outcomes to account for the multiple observations over time and varying numbers of observations per patient. With all continuous outcomes (total BQ and BQ subscale score, average and worst pain score, QOL scores, and BPI interference scores), an identity link function was used with a normal distribution. With binary outcomes (HADS anxiety and depression scores with a nominated cutoff point and PMI), a logit link function was used with a binary distribution. To investigate possible relationships between the outcomes, the intervention and time, the change from baseline was modeled for both Weeks 2 and 4, with time (weeks) as the within-subject factor. For BPI average and worst pain, we explored whether the following patient characteristics modified the effect of treatment with tests for interaction and/or heterogeneity: age, sex, education level (level completed), partner status (married or de facto vs. single, separated, or widowed), hospital setting (rural, regional, or urban), and non-english-speaking background. The model fitted for each outcome was outcome (Weeks 2 and 4) ¼ constant þoutcome (Week 0) þ week þ treatment group þdemographic variable þ (treatment group demographic variable). The Pearson correlation coefficient was calculated for the relationship between the pain diary and BPI average pain scores. Results We randomized 217 participants between January 2003 and June 2006, of whom 185 completed baseline assessments (Fig. 1). Participants mean age was 62 years old, and there was a higher proportion of women (57%) (Table 1). Participants had a wide range of cancer diagnoses. Participants from regional and rural centers made up 23%, and around 6% of participants came from a non-englishspeaking background but had adequate English for the study. For all outcomes, there was no difference between the two postrandomization time points, allowing us to average the effect of the treatment groups across both postrandomization time points. Effect on BQ Scores Baseline BQ score did not differ between centers, and there was no effect of age, gender, education level, marital status, non-englishspeaking background, or place of residence (rural vs. urban) on baseline total BQ (P > 0.15 for all characteristics).

5 Vol. 40 No. 1 July 2010 Standardized Cancer Pain Education for Patients 53 Fig. 1. Flow of patients though the trial. Barriers Questionnaire scores were low, with a mean for the whole group of 1.33 for the total BQ score (SD: 0.78), and no significant differences between the four treatment groups at baseline (Table 2). The BQ scores in intervention groups dropped more than the standard care group but did not reach statistical significance. Fig. 2 shows the difference in the mean change from baseline for the total BQ score averaged over Weeks 2 and 4. There was a significant difference in the change in the mean addiction subscale score between the standard care group (0.11) and the booklet group (mean: 0.38; difference: 0.49 with 95% CI: 0.00, 0.98, P ¼ 0.05), and the video group (mean: 0.49; difference: 0.60 with 95% CI: 0.07, 1.13, P ¼ 0.03). There was, however, no significant difference between the standard care group and the booklet and video group (mean: 0.21; difference: 0.32 with 95% CI: 0.20, 0.84, P ¼ 0.23) (Fig. 3). There was no evidence that the educational intervention affected other barrier subscale scores. Effect on BPI Average Pain and Worst Pain On a scale of 0e10, patients rated their baseline worst pain at 5.87 (SD: 2.69) (overall

6 54 Lovell et al. Vol. 40 No. 1 July 2010 Table 1 Baseline Demographic Features (n ¼ 158) Demographic Feature Standard Care, (n ¼ 40) Booklet Only, (n ¼ 37) Only, (n ¼ 36) Booklet, (n ¼ 45) Overall, (n ¼ 158) Female sex (% female) 22 (56) 21 (57) 25 (69) 22 (49) 90 (57) English as first language 37 (95) 36 (97) 33 (92) 40 (89) 146 (94) Type of cancer Bowel 5 (13) 2 (6) 2 (6) 3 (7) 12 (8) Breast 9 (22) 8 (22) 14 (39) 9 (20) 40 (25) Genitourinary 3 (8) 2 (6) 3 (8) 6 (13) 14 (9) Prostate 5 (13) 3 (8) 2 (6) 7 (16) 17 (11) Lung/mesothelioma 6 (15) 9 (25) 5 (14) 1 (20) 29 (18) Other 11 (27) 11 (29) 9 (25) 11 (24) 42 (27) Missing 1 (3) 2 (5) 1 (3) 0 (0) 4 (3) Highest education No certificate 7 (18) 10 (27) 8 (22) 8 (18) 33 (21) Junior certificate 8 (21) 9 (24) 6 (17) 13 (29) 36 (23) Senior certificate 8 (21) 4 (11) 3 (8) 5 (11) 20 (13) College of Technical and 3 (8) 3 (8) 5 (14) 5 (11) 16 (10) Further Education/trade University/tertiary 12 (31) 9 (24) 14 (39) 13 (29) 48 (31) Marital status Single 2 (5) 2 (5) 3 (8) 1 (2) 8 (5) Married/de facto 28 (72) 28 (76) 26 (72) 32 (71) 114 (73) Divorced/separated 5 (13) 4 (11) 3 (8) 6 (13) 18 (12) Widowed 4 (10) 3 (8) 4 (11) 5 (11) 16 (10) Hospital setting Rural 13 (33) 5 (14) 8 (22) 10 (22) 36 (23) Urban 26 (65) 32 (86) 28 (78) 35 (78) 121 (77) Age: mean (SD) 61 (12) 62 (12) 62 (15) 63 (12) 62 (13) mean), with the baseline average pain rated at 4.19 (SD: 2.39) (overall mean). There was a significant difference in the change in average pain score between the standard care group (mean: 0.02) and the booklet and video group (mean: 1.19; difference: 1.17 with 95% CI: 0.17, 2.17, P ¼ ). There were marginal differences between standard care and booklet alone (P ¼ 0.07) and standard care and video alone (P ¼ 0.09) (Fig. 4.) The presence of a partner increased the effect of any educational intervention on average pain scores compared with standard care (P ¼ 0.01). No other demographic variable influenced the effect of the intervention on average pain scores. Reductions in worst pain scores were significantly greater in the booklet and video group than in the standard care group ( 1.53 vs. 0.41; difference: 1.12 with 95% CI: 0.00, 2.23, P ¼ 0.05). There were no differences between standard care vs. booklet alone (P ¼ 0.52) and standard care vs. video alone (P ¼ 0.19) (Fig. 5). The effect of any intervention was again increased by the presence of a partner (P ¼ 0.004). The Pearson s correlation coefficients between the pain diary scores and the BPI average pain scores at Weeks 2 and 4 were 0.67 and 0.75, respectively. Effect on Pain Management Most patients were using some type of medication to control their pain, with 77% of patients using opioids at baseline. Overall, 22% were using inadequate analgesia at baseline as assessed by the PMI. There was a difference between the groups at baseline with the booklet and video group using more opioids (Fisher s exact test; P ¼ 0.05). There was evidence that use of opioids decreased significantly in the booklet group compared with the other groups (P ¼ 0.05). Average reduction in the percentage of participants using opioids was 14% in the booklet group, 2.5% in the video group, and 3.5% in the booklet and video group (Table 3). There was no significant difference between the intervention groups and standard care group for PMI outcomes (P ¼ 0.54). Effect on BPI Pain Interference and QOL The BPI interference scale score was 1.98 (0.89) indicating that pain interfered

7 Vol. 40 No. 1 July 2010 Standardized Cancer Pain Education for Patients 55 Outcome Measure Table 2 Baseline Characteristics for Outcome Measures (n ¼ 158) Standard Care (n ¼ 40) Booklet Only (n ¼ 37) Only (n ¼ 36) Booklet (n ¼ 45) Whole Group (n ¼ 158) Total BQdmean (SD) 1.37 (.92) 1.33 (.77) 1.30 (.82) 1.33 (.64) 1.33 (.78) Addiction subscale 1.58 (1.37) 1.71 (1.34) 1.84 (1.53) 1.36 (1.24) 1.61 (1.37) Tolerance 1.12 (1.34) 0.99 (1.22) 1.21 (1.45) 1.07 (1.27) 1.10 (1.31) Side effects 1.58 (1.16) 1.57 (.97) 1.75 (1.06) 1.77 (.86) 1.67 (1.01) Disease progression 2.31 (1.64) 2.14 (1.71) 1.91 (1.43) 2.27 (1.46) 2.17 (1.55) Fatalism 0.75 (1.07) 0.76 (.94) 0.64 (.84) 0.87 (.92) 0.76 (.94) Injections 1.69 (1.72) 1.36 (1.52) 1.37 (1.56) 1.28 (1.37) 1.42 (1.54) Good patient 0.78 (1.03) 0.86 (1.05) 0.74 (1.14) 0.73 (.84) 0.78 (1.00) Treatment distraction 0.97 (1.29) 1.02 (1.17) 0.54 (.92) 0.87 (.88) 0.85 (1.08) HADSdanxietyd 11þ 13 (33) 12 (32) 12 (33) 14 (31) 51 (32) HADSddepressiond 11þ 7 (17) 9 (24) 4 (11) 4 (9) 24 (15) BPIdmean (SD) Average pain (0e10) 3.75 (2.58) 3.92 (2.31) 4.45 (2.14) 4.60 (2.47) 4.19 (2.39) Worst pain (0e10) 5.57 (2.98) 5.38 (2.82) 6.10 (2.45) 6.34 (2.47) 5.87 (2.69) Interference (0e4) 1.96 (1.04) 1.95 (.94) 1.99 (.79) 2.02 (.81) 1.98 (.89) Pain management Analgesic use No analgesia 2 (5) 2 (5) 2 (6) 1 (2) 7 (5) Nonsteroidal and/or 10 (26) 8 (22) 8 (22) 3 (7) 29 (19) acetaminophen Weak opioids used 8 (21) 2 (5) 2 (6) 9 (21) 21 (14) Strong opioids used 18 (48) 25 (68) 23 (66) 30 (70) 96 (63) PMI Inadequate analgesia 9 (24) 7 (19) 9 (26) 7 (16) 32 (21) Adequate analgesia 19 (76) 30 (81) 26 (74) 36 (84) 111 (79) QOLdmean (SD) 6.05 (2.00) 5.58 (2.60) 5.88 (2.39) 5.78 (2.30) 5.82 (2.31) moderately with activity. There was no significant difference in the change in interference scores between the four treatment groups (P ¼ 0.96). There was also no significant difference between the groups for QOL scores (P ¼ 0.55). Effect on Anxiety and Depression The groups had similar scores at baseline HADS anxiety and depression scores. A moderate proportion (32%) of patients had scores consistent with clinically significant anxiety; 15% had scores consistent with clinically significant depression. There was no significant change in anxiety or depression in any of the four groups (all P > 0.2). The number of participants who had clinically significant scores for anxiety or depression remained stable throughout the study. Booklet Booklet & P=0.2 P=0.3 P=0.2 General Feedback Of 118 participants who received the video and/or booklet and responded to the feedback question, 106 (90%) indicated that they felt the intervention was helpful and 92 (78%) indicated that they felt the intervention intervention standard care Fig. 2. Difference in mean change from baseline for total BQ score (n ¼ 158). SC ¼ standard care.

8 56 Lovell et al. Vol. 40 No. 1 July 2010 Booklet P=0.05 Booklet P= P= P=0.19 Booklet & P=0.23 Booklet & P=0.05 helped to make to them more involved in their pain management. The Pearson correlation coefficients for the pain diary scores and BPI average pain scores at Weeks 2 and 4 were 0.67 and 0.75, respectively. Booklet Booklet & intervention intervention standard care (SC) Fig. 3. Difference in mean change from baseline for addiction subscale score (n ¼ 158). P=0.07 P=0.08 P=0.02 standard care (SC) Fig. 4. Difference in mean change from baseline, average pain (n ¼ 158) intervention standard care (SC) Fig. 5. Difference in mean change from baseline, worst pain (n ¼ 158). Endpoint score is average of Weeks 2 and 4. Discussion In this study of advanced cancer patients with pain, a brief self-administered educational intervention consisting of a video and booklet reduced the average and worst pain scores. The important barrier of fear of addiction to analgesics was also reduced. Participants reported feeling that they were more involved with their own pain management. This was achieved without increase in anxiety or depression or reduced QOL. The reduction in pain scores in the presence of reduced opioid use was an unexpected finding and should be viewed as a hypothesisgenerating result, rather than as a definitive answer. It was predicted that information about pain relief would increase the consumption of opioids. Perhaps the intervention itself was having an effect on pain levels. It may be that patients with an increased understanding of what is going on in their bodies and how to manage pain have an increased sense of control and a concomitant reduction in the pain. The importance of perceived control over pain has been previously highlighted. 21 The high correlation between average pain score over the last two weeks and pain scores

9 Vol. 40 No. 1 July 2010 Standardized Cancer Pain Education for Patients 57 Table 3 Opioid Use Use of Opioids (Using Weak or Strong Opioids), Standard Care (n ¼ 40) Booklet Only (n ¼ 37) Only (n ¼ 36) Booklet and (n ¼ 45) Booklet and/or (n ¼ 118) Week 0 26 (68) 27 (73) 25 (71) 39 (91) 91 (79) Week 2 27 (73) 22 (61) 25 (71) 37 (88) 84 (74) Week 4 22 (71) 20 (57) 21 (66) 33 (85) 74 (70) recorded daily in a diary suggests that clinicians can be confident that patients can report average pain over the preceding two weeks accurately. There are a number of strengths in this study. Most important, a wide diversity of participants from rural, regional, and metropolitan centers was included, and patients had a range of diagnoses and educational backgrounds. Patient education is clearly a challenging area when attempting to improve pain-related outcomes. Two recent articles highlight this. Ward et al. 24 used a representational intervention based on theories of cognitive representations of illness and processes of conceptual change. The patient spent 20e60 minutes with a research nurse examining and correcting misconceptions that may hinder cancer pain relief. The control was a booklet about pain relief, and the patient was given two opportunities to ask questions about the information in the booklet. Greater improvements were shown in the total BQ II outcome and in reductions in usual pain severity (on a categorical scale of none, mild, moderate, or severe) than in the control group. There was no effect on BPI pain severity, PMI, or pain interference despite the comprehensive intervention, and this may be because the comparator standardized intervention was also effective. A less complex and resource intensive intervention was reported recently by Syrjala et al., in which American participants were randomized to receive an educational intervention about pain or nutrition. 22 The intervention was matched for the groups and consisted of a video and an accompanying handbook, which was discussed with the participants by a study nurse with a focus on particular barriers that were relevant to them. The intervention included a follow-up phone call to address individual concerns. Baseline BQ was 1.8, which was higher than the baseline BQ reported in our research of 1.33.The decrease in BPI usual pain was 0.8 compared with the decrease of 0.99 demonstrated in this study. The pain training group used higher doses of opioid. Worst pain and pain interference were not significantly improved. It is of interest that our mean baseline barriers scores were lower than in many other studies, including other Australian work completed in This may represent slow impact of education targeting health professionals over the previous five years, changes in availability of pain management resources, or volunteer bias. Study of barriers in a general metastatic cancer outpatient population by Ward et al. 24 revealed baseline BQ score of 1.47e1.66. The finding of improved outcome in the presence of a partner is of interest and is consistent with other data but needs further investigation. 16 Our study was striking because a standardized intervention, not nurse administered and not tailored to individual beliefs, resulted in significant benefits in average and worst pain scores. This contrasts with other studies of educational interventions including those with individualized pain education, which showed no significant benefit in pain scores. 21,35 The combination of video and booklet was most effective, and it may be because the structured targeted content was reinforced in both media. Although clearly not replacing education by trusted health professionals, as the intervention is effective, it can be given to patients with pain and cancer in addition to standard care. There also are limitations to this work. The study was conducted in an English-speaking population. The needs of people with cancer from non-english-speaking backgrounds in Australia, especially Aboriginal and Torres Strait Islander populations, need to be addressed. Blinding was not considered practical. Compliance with group allocation was only assessed by the proxy measure of asking whether

10 58 Lovell et al. Vol. 40 No. 1 July 2010 the intervention was helpful in the feedback questions. The attrition rate was higher than expected. The approach we took was to assign the full Type I error rate to answering the primary hypothesis. Therefore, all other statistical comparisons are hypothesis-generating and exploratory and unadjusted for an inflated Type I error. The significant findings in average and worst pain should therefore be cautiously interpreted. The lack of attention control is a design limitation, but for ethical reasons, it was thought that such an approach would not be appropriate with patients in pain. In summary, this study has shown that people with advanced cancer and pain can benefit from a simple educational intervention by improving average and worst pain scores and reducing fears of opioid addiction. Most (78%) participants reported a feeling of being more involved with their own pain management. The book and video are suitable for all English-speaking patients with advanced cancer and pain. Their feasibility, modest cost, popularity, and effectiveness suggest that they could usefully be combined with other strategies for reducing the burden of cancer pain. Acknowledgments The authors thank Ruth Toppler, who was the Clinical Trial Coordinator, and the clinical trial nurses from Cancer Trials New South Wales, especially Marita Tipene at Nepean Hospital, Sue Whitney at Lismore Base Hospital, Margaret Chamen at Tamworth Base Hospital, and Helen Goldsmith at St. George Hospital. They also thank the participants in the video, especially the patients and carer; Dr. Paul Heinrich and the Pam McLean Cancer Communications Centre; Professor Michael Cousins; and Igor Auzins and Christina de Podolinsky from the Room with a View production company. They are grateful to The New South Wales Cancer Council, which produced the booklet and distributed the booklet and video. References 1. Daut RL, Cleeland CS. The prevalence and severity of pain in cancer. Cancer 1982;50(9): 1913e van den Beuken-van Everdingen MHJ, de Rijke JM, Kessels AG, et al. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol 2007;18:1437e Ferrell BR, Grant M, Rhiner M, Padilla G. Home care: maintaining quality of life for patient and family. Oncology 1992;6(Suppl 2):136e Massie M, Holland J. The cancer patient with pain: psychiatric complications and their management. J Pain Symptom Manage 1992;7:99e Juver J, Vercosa N. Depression in patients with advanced cancer and pain. Rev Bras Anestesiol 2008;58:287e McMillan S, Tofthagen C, Morgan M. Relationships among pain, sleep disturbances, and depressive symptoms in outpatients from a comprehensive cancer center. Oncol Nurs Forum 2008;35: 603e Tavoli A, Montazeri A, Roshan R, Tavoli Z, Melyani M. Depression and quality of life in cancer patients with and without pain: the role of pain beliefs. BMC Cancer 2008;8: Ferrell B, Bornemann T, Juarez G. Integration of pain education into home care. J Palliat Care 1998;14:62e Ferrell BR, Rhiner M, Cohen M, Grant M. Pain as a metaphor for illness. Part I: Impact of cancer pain on family caregivers. Oncol Nurs Forum 1991;18:1303e Yates P, Aranda S, Edwards E, et al. Family caregivers experiences and involvement with cancer pain management. J Palliat Care 2004;20:287e Oldham L, Kristjanson LJ. Development of a pain management programme for family carers of advanced cancer patients. Int J Palliat Nurs 2004;10:91e Potter V, Wiseman C, Dunn S, Boyle F. Patient barriers to optimal cancer pain control. Psychooncology 2003;12:153e Deandrea S, Montanari M, Moja L, Apolone G. Prevalence of undertreatment in cancer pain. A review of published literature. Ann Oncol 2008;19: 1985e Ward S, Goldberg N, Miller-McCauley V, et al. Patient-related barriers to management of cancer pain. Pain 1993;52:319e McPherson C, Higginson I, Hearn J. Effective methods of giving information in cancer: a systematic literature review of randomized controlled trials. J Public Health Med 2001;23:227e Miaskowski C, Dodd M, West C, et al. Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol 2004;22:1713e de Wit R, van Dam F. From hospital to home care: a randomized controlled trial of a Pain

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