Longitudinal Follow-Up Study Using the Distress and Impact Thermometer in an Outpatient Chemotherapy Setting

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1 236 Journal of Pain and Symptom Management Vol. 43 No. 2 February 2012 Original Article Longitudinal Follow-Up Study Using the Distress and Impact Thermometer in an Outpatient Chemotherapy Setting Takashi Yamaguchi, MD, Tatsuya Morita, MD, Yumi Sakuma, RN, CNS, Asayo Kato, RN, CN, Yukihiro Kunimoto, MD, and Yasuo Shima, MD Department of Palliative Medicine (T.Y., Y.Sh.), Tsukuba Medical Center Hospital, Tsukuba; and Department of Palliative and Supportive Care (T.M.), Department of Medical Oncology (Y.K.) and Oncology Center (Y.Sa., A.K.), Seirei Mikatahara General Hospital, Shizuoka, Japan Abstract Context. Although the combined use of the Impact Thermometer (IT) with the Distress Thermometer (DT), DIT, is reported to be a validated screening tool for clinically significant psychological distress in cancer patients, its longitudinal changes in the outpatient chemotherapy setting have not been examined. Objectives. The objective was to clarify the longitudinal changes in distress evaluated by the DIT and effects of coexisting physical symptoms in an outpatient chemotherapy setting. Methods. A total of 297 patients who underwent chemotherapy for any malignancy on an outpatient basis were included. All the participants completed a questionnaire that included the DIT and intensities of seven physical symptoms (pain, somnolence, fatigue, dyspnea, appetite loss, abdominal distention, and nausea) at the initial and follow-up visit. Results. Although 109 patients had moderate or severe distress (the DT $4 and IT $3) at the initial visit, 46.8% of these patients improved their distress (DIT score below the cutoff of moderate distress) at their follow-up visit. Also, 85 patients had severe distress (DT $5 and IT $4) at the initial visit, and 43.5% of these patients improved their distress (DIT score below the cutoff of severe distress) at their follow-up visit. In a subgroup of patients who had no severe physical symptoms at the initial visit, 69.0% and 68.4% of the patients with moderate or severe distress and severe distress at the initial visit, respectively, improved their distress (DIT scores below the cutoff of moderate and severe distress) at the follow-up visit. Conclusion. The distress evaluated by DIT can change on sequential measurements within short time intervals. Further study is needed to determine the appropriate use of the DIT for the screening and monitoring of psychological distress Address correspondence to: Takashi Yamaguchi, MD, Department of Palliative Medicine, Tsukuba Medical Center Hospital, 1-3-1, Amakubo, Tsukuba, Japan ikagoro@pop06.odn.ne.jp Ó 2012 U.S. Cancer Pain Relief Committee Published by Elsevier Inc. All rights reserved. Accepted for publication: March 15, /$ - see front matter doi: /j.jpainsymman

2 Vol. 43 No. 2 February 2012 Longitudinal Changes in the Distress and Impact Thermometer 237 in an outpatient chemotherapy setting. J Pain Symptom Manage 2012;43:236e243. Ó 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. Key Words Distress thermometer, impact thermometer, psychological distress, outpatient chemotherapy Introduction Increasing numbers of cancer patients are receiving chemotherapy in an outpatient setting. 1 Some previous studies have suggested that they have a broad range of palliative care needs, including physical, psychiatric, psychological, and social problems. 2e6 Psychological distress is one of the most important problems in cancer patients. Psychological distress ranges from the normal distress reaction to the pathologic reaction and psychiatric diseases, 7 such as adjustment disorder and major depression, with prevalences of 7.5%e35% and 2%e12% of all cancer patients in Japan, respectively. 8e13 Psychological distress impairs the quality of life of cancer patients. 14,15 Although psychotherapy and pharmacotherapy are effective in reducing psychological distress, the psychological distress is often underrecognized by physicians and other medical staff. 16,17 Thus, recent guidelines recommend screening for psychological distress in all cancer patients. 18 The Distress Thermometer (DT) is a validated screening tool for clinically significant distress. 19e21 However, our previous study showed that the DT score may change on sequential measurements and may be strongly influenced by physical symptoms in an outpatient chemotherapy setting. 22 The Impact Thermometer (IT) is a screening tool that evaluates impact of distress on daily life activities, and the combination of the IT with the DT showed higher specificity with preserved sensitivity in the screening of clinically significant psychological distress than using the DT alone. 23 Thus, we developed a symptom assessment questionnaire that included both the DT and IT. The aim of this study was to clarify the longitudinal changes in distress evaluated by the use of the combined DT and IT (DIT) ;and examine the effects of coexisting physical symptoms thereon in an outpatient chemotherapy setting. Patients and Methods This longitudinal observational study was a retrospective analysis of prospectively collected data. The study subjects were all adult cancer patients scheduled to undergo outpatient chemotherapy for any type of malignancy at a general hospital that is also a regional cancer center in the city of Hamamatsu, Japan. At the time of each hospital visit for chemotherapy, the nurses distributed a self-report questionnaire before the start of chemotherapy, instructed the patients on how to complete the questionnaire, and asked the participants to answer the questions. This intervention was part of the usual clinical practice. We collected the data obtained on the initial visit during the study period and on a follow-up visit one to three weeks after the initial visit. Demographic and medical data, such as age, sex, and primary cancer site, were retrospectively obtained from the medical charts. The patients were enrolled in the study between May and November The institutional review board of our hospital approved the ethical and scientific validity of a retrospective analysis of the questionnaire data obtained as part of routine clinical activities. All patients gave written consent that their clinical information could be used for clinical research. Questionnaire We developed the questionnaire based on existing validated instruments. The questionnaire included the following: 1) 0e10 numerical rating scales for seven physical symptoms (pain, somnolence, fatigue, dyspnea, appetite loss, abdominal distention, and nausea) adopted from the Japanese version of the M.D. Anderson Symptom Inventory, 24 2) the DT (a oneitem questionnaire with an 11-point Likert scale examining psychological distress, ranging from zero to 10 and with a higher score indicating greater distress), and 3) the IT (a one-item

3 238 Yamaguchi et al. Vol. 43 No. 2 February 2012 questionnaire with an 11-point Likert scale examining the impact of psychological distress on daily living activities, ranging from zero to 10 and with a higher score indicating a less favorable status). 19,23 Statistical Analysis We identified all the patients who had a DIT score above the cutoff for moderate and severe distress at the initial visit. We used a cutoff point of 4 on the DTand 3 on the IT for moderate distress and 5 on the DT and 4 on the IT for severe distress, which were reported as the cutoff points for major depression and/or adjustment disorder and major depression alone, respectively, in previous research. 23 Then, we classified them into two groups as follows: those whose DIT score remained above the cutoff (sustained distress group) and another group whose score dropped below the cutoff (improved distress group) at the follow-up visit. We compared the demographic data and intensities of the coexisting physical symptoms between the sustained distress group and the improved distress group. For comparison purposes, we defined severe and moderate intensities for five physical symptoms (pain, fatigue, dyspnea, appetite loss, and nausea) based on the results of previous research as follows: pain, 2e4 for moderate and 5e10 for severe; fatigue, 2e4 and 5e10; dyspnea, 3e6 and 7e10; appetite loss, 4e6 and 7e10; and nausea, 4e6 and 7e For the other symptoms (somnolence and abdominal distention), we adopted the definitions for moderate and severe as 4e6 and 7e10, respectively, based on the results of previous research. 22 We defined patients as having severe physical symptoms if they had one or more severe symptoms of pain, somnolence, fatigue, dyspnea, appetite loss, abdominal distention, or nausea. To adjust for confounding factors affecting changes in physical symptom intensity, we assessed the longitudinal change in their distress evaluated by DIT in patients who did not have any severe physical symptoms at the initial visit. Statistical analyses were performed by using Mann-Whitney U tests for assessing continuous variables and Chi-square tests or Fisher s exact tests for assessing categorical variables, where appropriate. For the statistical analysis, we used SPSS for Windows, version 19.0 (IBM Japan Institute, Tokyo, Japan). Results Patient Characteristics During the study period, 302 patients received outpatient chemotherapy; five patients did not complete the questionnaire (compliance rate, 98%). In total, 297 patients completed the questionnaire at the initial and follow-up visits. The mean interval between the initial and follow-up visits was days. Table 1 summarizes the background characteristics of the eligible patients. Longitudinal Change in Distress Evaluated by the DIT Of the 297 patients, 109 (36.7%) had moderate or severe distress (DITscore above the cutoff for moderate distress) and 85 patients (28.6%) had severe distress (DIT score above the cutoff for severe distress) at the initial visit (Fig. 1). Of the 109 patients with moderate or severe distress at the initial visit, 51 patients (46.8%) improved their distress (DIT score below the cutoff for moderate distress) at the follow-up visit. Among the 58 patients who sustained their distress, 82.8% (44 of 58) of the patients had one or more severe physical symptoms. Furthermore, of the 85 patients above with severe distress at the initial visit, 37 patients (43.5%) improved their distress at the follow-up visit. Also, among the 48 patients who sustained their distress, 79.2% (38 of 48) of the patients had one or more severe physical symptoms. Among 188 patients who had a DIT score below the cutoff for moderate distress at the initial visit, Table 1 Patient Characteristics (n ¼ 297) Characteristic n (%) Age (SD), years Sex Male 169 (57.1) Female 127 (42.9) Primary site Lung 98 (33.1) Breast 54 (18.2) Colorectal 47 (15.9) Stomach 41 (13.9) Pancreas 11 (4.0) Gallbladder/bile duct 10 (3.4) Prostate 4 (1.4) Lymphoma 4 (1.4) Others 26 (8.7) SD ¼ standard deviation. Some data do not add up to 100% because of missing values.

4 Vol. 43 No. 2 February 2012 Longitudinal Changes in the Distress and Impact Thermometer 239 At initial assessment Moderate or severe distress ( n = 109) At follow-up Any physical symptom Sustained distress severe: n = 44 ( n = 58) moderate: n = 10 non ~ mild: n = 4 Any physical symptom Improved distress severe: n = 12 ( n = 51) moderate: n = 28 non ~ mild: n = 11 Severe distress ( n = 85) Any physical symptom Sustained distress severe: n = 38 ( n = 48) moderate: n = 7 non ~ mild: n = 3 Any physical symptom Improved distress severe: n = 11 ( n = 37) moderate: n = 16 non ~ mild: n = 10 Fig. 1. Change in the distress evaluated by the DIT. 172 patients (91.5%) still had a score below the cutoff. Change in Distress Evaluated by DIT and Physical Symptom Intensity Table 2 shows a comparison of the demographic data and physical symptom intensities among patients with sustained distress and improved distress. Among the patients with moderate or severe distress at the initial visit, no significant differences in the demographic data or all the physical symptom intensities at the initial visit, except for pain, dyspnea, and fatigue, were observed between the patients who sustained their distress and those who improved their distress at the follow-up visit. At the follow-up visit, the intensities of four physical symptoms were significantly higher among the patients with sustained distress than among those who improved their distress: pain (P < 0.001), appetite loss (P < 0.001), fatigue (P < 0.001), and somnolence (P < 0.001). Three other physical symptoms tended to have a higher intensity among the patients with sustained distress: dyspnea (P ¼ 0.149), nausea (P ¼ 0.123), and abdominal distention (P ¼ 0.267). Similarly, among the patients with severe distress at the initial visit, no significant differences in the demographic data or all the physical symptom intensities at the initial visit, except for pain and dyspnea, were observed between the patients who sustained their distress and those who improved their distress at the follow-up visit. At the follow-up visit, the

5 240 Yamaguchi et al. Vol. 43 No. 2 February 2012 Table 2 Comparison of Patients Who Sustained Distress and Improved Distress at Follow-Up Patients With Moderate or Severe Distress at Initial Visit (n ¼ 109) Patients With Severe Distress at Initial Visit (n ¼ 85) At Follow-Up Sustained Distress (n ¼ 58) Improved Distress (n ¼ 51) P-value Sustained Distress (n ¼ 48) Improved Distress (n ¼ 37) P-value Age (SD), years Sex, n (%) Male 34 (58.6) 28 (54.9) (59.6) 31 (54.4) Female 24 (41.4) 23 (45.1) 21 (40.4) 26 (45.6) Initial visit, mean SD Pain Dyspnea Nausea Appetite loss Abdominal distention Fatigue Somnolence Follow-up visit, mean SD Pain < Dyspnea Nausea Appetite loss < <0.001 Abdominal distention Fatigue < <0.001 Somnolence < intensities of five physical symptoms were significantly higher among the patients with sustained distress: pain (P ¼ 0.001), dyspnea (P ¼ 0.021), appetite loss (P < 0.001), fatigue (P < 0.001), and somnolence (P ¼ 0.009). Two other physical symptoms tended to have a higher intensity among the patients with sustained distress: nausea (P ¼ 0.051) and abdominal distention (P ¼ 0.114). Change in Distress Evaluated by the DIT Among Patients Without Severe Physical Symptoms Fig. 2 shows the longitudinal change in distress evaluated by the DIT of a subgroup of patients who did not have any severe physical symptoms at the initial visit. Twenty-nine patients had moderate or severe distress, and 19 patients had severe distress at the initial visit in this subgroup. Among the 29 patients with moderate or severe distress, 20 patients (69.0%) improved their distress. Among the 19 patients with severe distress, 13 patients (68.4%) improved their distress. Discussion This is, to the best of our knowledge, the first study to examine longitudinal changes in distress evaluated by the combination of the IT with the DT in an outpatient chemotherapy setting. This study had three major findings. The first was the longitudinal follow-up data for distress evaluated by the DIT of patients treated in an outpatient chemotherapy setting. We previously reported that the DT scores of most patients in this setting changed within a few weeks. 22 Adding the IT to the DT, with the initial intention of increasing the specificity of the screening for psychological distress, demonstrated that the DIT scores changed from above the cutoff to below after a mean duration of 11 days in about half of the patients. This finding indicates that the use of a single DIT for the screening of psychological distress would result in overscreening. And, in this setting, referring all the patients with a single DITscore above the cutoff to the psychiatry department may result in a heavy burden for not only psychiatrists but also for the patients because many patients generally have a negative attitude toward psychiatry referral. 26,27 This result suggests that referring all patients who have a single positive DIT screening result is not practical because the DIT scores of many patients will change within a short interval; thus, a more practical screening method is needed.

6 Vol. 43 No. 2 February 2012 Longitudinal Changes in the Distress and Impact Thermometer 241 At initial a s ses s m ent At f o llow-up Moderate or severe distress ( n = 29 ) Sustained distress ( n = 9) Improved distress ( n = 20) Severe distress ( n = 19) Sustained distress ( n = 6) Improved distress ( n = 13) Fig. 2. Change in the distress evaluated by the DIT of patients who did not have any severe physical symptoms. A second major finding of this study was the significant and clinically interpretable association between sustained distress above the cutoff and the intensities of physical symptoms. In this study, most patients with sustained distress had one or more severe physical symptoms. Furthermore, the patients with sustained distress tended to have higher intensities for all the physical symptoms at the follow-up visit. These findings suggest that the change in the physical symptom intensity may affect the rapid change in status of the distress evaluated by the DIT. How to handle related physical symptoms during the diagnosis of mood disorders in patients with physical illness remains an unsolved problem. 28 Thus, this finding strongly indicates that physicians should note that a high DIT score is not simply an indicator of psychiatric comorbidity, and they should interpret the DIT score while taking changes in physical symptom intensity into consideration. A third major finding was the clarification of the longitudinal changes in the status of the distress evaluated by the DIT among patients who did not have any severe physical symptoms. In this study, we examined patients who did not have any severe physical symptoms at the initial visit to remove the influence of changes in physical symptom intensity. Even within this population, the DIT score dropped to below the cutoff point at the follow-up visit in about 70% of the patients with a DIT score above the cutoff point at the initial visit. A positive DIT score, thus, may indicate that the patient has a certain psychological status, but not necessarily a definite psychiatric disorder, that may change even without the influence of physical symptoms. This finding suggests that physicians should not consider referring all patients with a single positive result to psychiatrists but rather should follow the score longitudinally when using the DIT to screen for psychological distress. The present study has some limitations. First, as this study was limited to that of an outpatient chemotherapy setting and examined patients with heterogeneous primary sites, these results cannot be automatically generalized to a specific population. However, we believe that this limitation is not a critical flaw because a useful system that can be used to screen for psychological distress in a heterogeneous outpatient chemotherapy setting is needed. Second, this study was conducted at a single institution. We believe, however, that the results can be generalizable to other institutions because our institution functions as a typical regional general hospital. In conclusion, although the DIT may be a useful tool for monitoring psychological distress, its score can be influenced by coexisting physical symptoms and may change

7 242 Yamaguchi et al. Vol. 43 No. 2 February 2012 sequentially within a short time interval in an outpatient chemotherapy setting. Because the optimal interval for the reevaluation of the DIT and timing of referral to a psychiatrist have not been explored, further study is needed to determine the appropriate usage of the DIT for the screening and monitoring of psychological distress in an outpatient chemotherapy setting. A promising method to be tested in a future study includes a longterm follow-up of the distress evaluated by the DIT with a diagnostic interview conducted by an experienced psychiatrist. Disclosures and Acknowledgments The authors declare no conflicts of interest. References 1. Earle CC, Neville BA, Landrum MB, et al. Trends in the aggressiveness of cancer care near the end of life. J Clin Oncol 2004;22:315e Bang SM, Park SH, Kang HG, et al. Changes in quality of life during palliative chemotherapy for solid cancer. Support Care Cancer 2005;13: 515e Matsuyama R, Reddy S, Smith TJ. Why do patients choose chemotherapy near the end of life? A review of the perspective of those facing death from cancer. J Clin Oncol 2006;24: 3490e Newell S, Sanson-Fisher RW, Girgis A, Ackland S. The physical and psycho-social experiences of patients attending an outpatient medical oncology department: a cross-sectional study. Eur J Cancer Care (Engl) 1999;8:73e Schonwetter RS, Roscoe LA, Nwosu M, Zilka B, Kim S. Quality of life and symptom control in hospice patients with cancer receiving chemotherapy. J Palliat Med 2006;9:638e Whitmer KM, Pruemer JM, Nahleh ZA, Jazieh AR. Symptom management needs of oncology outpatients. J Palliat Med 2006;9:628e Smith GF, Toonen TR. Primary care of the patient with cancer. Am Fam Physician 2007;75:1207e Akechi T. Major depression, adjustment disorders, and post-traumatic stress disorder in terminally ill cancer patients: associated and predictive factors. J Clin Oncol 2004;22:1957e Akechi T, Okamura H, Nishiwaki Y, Uchitomi Y. Psychiatric disorders and associated and predictive factors in patients with unresectable nonsmall cell lung carcinoma: a longitudinal study. Cancer 2001; 92:2609e Kugaya A, Akechi T, Okuyama T, et al. Prevalence, predictive factors, and screening for psychologic distress in patients with newly diagnosed head and neck cancer. Cancer 2000;88:2817e Minagawa H, Uchitomi Y, Yamawaki S, Ishitani K. Psychiatric morbidity in terminally ill cancer patients. A prospective study. Cancer 1996; 78:1131e Okamura H, Watanabe T, Narabayashi M, et al. Psychological distress following first recurrence of disease in patients with breast cancer: prevalence and risk factors. Breast Cancer Res Treat 2000;61: 131e Okamura M. Psychiatric disorders following first breast cancer recurrence: prevalence, associated factors and relationship to quality of life. Jpn J Clin Oncol 2005;35:302e Frick E, Tyroller M, Panzer M. Anxiety, depression and quality of life of cancer patients undergoing radiation therapy: a cross-sectional study in a community hospital outpatient centre. Eur J Cancer Care (Engl) 2007;16:130e Grassi L, Indelli M, Marzola M, et al. Depressive symptoms and quality of life in home-care-assisted cancer patients. J Pain Symptom Manage 1996;12: 300e McDonald MV, Passik SD, Dugan W, et al. Nurses recognition of depression in their patients with cancer. Oncol Nurs Forum 1999;26:593e Passik SD, Dugan W, McDonald MV, et al. Oncologists recognition of depression in their patients with cancer. J Clin Oncol 1998;16: 1594e Holland JC, Andersen B, Breitbart WS, et al. Distress management. J Natl Compr Canc Netw 2010;8:448e Akizuki N, Akechi T, Nakanishi T, et al. Development of a brief screening interview for adjustment disorders and major depression in patients with cancer. Cancer 2003;97:2605e Roth AJ, Kornblith AB, Batel-Copel L, et al. Rapid screening for psychologic distress in men with prostate carcinoma: a pilot study. Cancer 1998;82:1904e Jacobsen PB, Donovan KA, Trask PC, et al. Screening for psychologic distress in ambulatory cancer patients. Cancer 2005;103:1494e Yamagishi A, Morita T, Miyashita M, Kimura F. Symptom prevalence and longitudinal follow-up in cancer outpatients receiving chemotherapy. J Pain Symptom Manage 2009;37:823e Akizuki N, Yamawaki S, Akechi T, Nakano T, Uchitomi Y. Development of an Impact Thermometer for use in combination with the Distress Thermometer as a brief screening tool for adjustment disorders and/or major depression in cancer patients. J Pain Symptom Manage 2005;29:91e99.

8 Vol. 43 No. 2 February 2012 Longitudinal Changes in the Distress and Impact Thermometer Okuyama T. Japanese version of the M.D. Anderson Symptom Inventory: a validation study. J Pain Symptom Manage 2003;26:1093e Given B, Given C, Sikorskii A, et al. Establishing mild, moderate, and severe scores for cancer-related symptoms: how consistent and clinically meaningful are interference-based severity cut-points? J Pain Symptom Manage 2008;35: 126e Endo C, Akechi T, Okuyama T, et al. Patientperceived barriers to the psychological care of Japanese patients with lung cancer. Jpn J Clin Oncol 2008;38:653e Okuyama T, Endo C, Seto T, et al. Cancer patients reluctance to disclose their emotional distress to their physicians: a study of Japanese patients with lung cancer. Psychooncology 2008;17: 460e Cohen-Cole SA, Stoudemire A. Major depression and physical illness. Special considerations in diagnosis and biologic treatment. Psychiatr Clin North Am 1987;10:1e17.

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