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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 $4) at the initial visit, and 43.5% of these patients improved their distress (DIT score below the cutoff of severe distress) at their follow-up visit. In a subgroup of patients who had no severe physical symptoms at the initial visit, 69.0% and 68.4% of the patients with moderate or severe distress and severe distress at the initial visit, respectively, improved their distress (DIT scores below the cutoff of moderate and severe distress) at the follow-up visit. Conclusion. The distress evaluated by DIT can change on sequential measurements within short time intervals. Further study is needed to determine the appropriate use of the DIT for the screening and monitoring of psychological distress Address correspondence to: Takashi Yamaguchi, MD, Department of Palliative Medicine, Tsukuba Medical Center Hospital, 1-3-1, Amakubo, Tsukuba, Japan 305-8558. E-mail: [email protected] Accepted for publication: March 15, 2011. Ó 2012 U.S. Cancer Pain Relief Committee Published by Elsevier Inc. All rights reserved. 0885-3924/$ - see front matter doi:10.1016/j.jpainsymman.2011.03.011 236 Journal of Pain and Symptom Management Vol. 43 No. 2 February 2012

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Page 1: Longitudinal Follow-Up Study Using the Distress and Impact Thermometer in an Outpatient Chemotherapy Setting

236 Journal of Pain and Symptom Management Vol. 43 No. 2 February 2012

Original Article

Longitudinal Follow-Up Study Usingthe Distress and Impact Thermometerin an Outpatient Chemotherapy SettingTakashi Yamaguchi, MD, Tatsuya Morita, MD, Yumi Sakuma, RN, CNS,Asayo Kato, RN, CN, Yukihiro Kunimoto, MD, and Yasuo Shima, MDDepartment 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 screeningtool for clinically significant psychological distress in cancer patients, itslongitudinal changes in the outpatient chemotherapy setting have not beenexamined.

Objectives. The objective was to clarify the longitudinal changes in distressevaluated by the DIT and effects of coexisting physical symptoms in an outpatientchemotherapy setting.

Methods. A total of 297 patients who underwent chemotherapy for anymalignancy on an outpatient basis were included. All the participants completeda questionnaire that included the DIT and intensities of seven physical symptoms(pain, somnolence, fatigue, dyspnea, appetite loss, abdominal distention, andnausea) at the initial and follow-up visit.

Results. Although 109 patients had moderate or severe distress (the DT $4 andIT $3) at the initial visit, 46.8% of these patients improved their distress (DITscore below the cutoff of moderate distress) at their follow-up visit. Also, 85patients 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 severedistress) at their follow-up visit. In a subgroup of patients who had no severephysical symptoms at the initial visit, 69.0% and 68.4% of the patients withmoderate or severe distress and severe distress at the initial visit, respectively,improved their distress (DIT scores below the cutoff of moderate and severedistress) at the follow-up visit.

Conclusion. The distress evaluated by DIT can change on sequentialmeasurements within short time intervals. Further study is needed to determine theappropriate use of theDIT for the screening andmonitoring of psychological distress

Address correspondence to: Takashi Yamaguchi, MD,Department of Palliative Medicine, TsukubaMedical Center Hospital, 1-3-1, Amakubo, Tsukuba,Japan 305-8558. E-mail: [email protected]

Accepted for publication: March 15, 2011.

� 2012 U.S. Cancer Pain Relief CommitteePublished by Elsevier Inc. All rights reserved.

0885-3924/$ - see front matterdoi:10.1016/j.jpainsymman.2011.03.011

Page 2: Longitudinal Follow-Up Study Using the Distress and Impact Thermometer in an Outpatient Chemotherapy Setting

Vol. 43 No. 2 February 2012 237Longitudinal Changes in the Distress and Impact Thermometer

in an outpatient chemotherapy setting. J Pain SymptomManage 2012;43:236e243.� 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Key Words

Distress thermometer, impact thermometer, psychological distress, outpatient chemotherapy

IntroductionIncreasing numbers of cancer patients are

receiving chemotherapy in an outpatientsetting.1 Some previous studies have suggestedthat they have a broad range of palliative careneeds, including physical, psychiatric, psycho-logical, and social problems.2e6 Psychologicaldistress is one of the most important problemsin cancer patients. Psychological distressranges from the normal distress reactionto the pathologic reaction and psychiatricdiseases,7 such as adjustment disorder and ma-jor depression, with prevalences of 7.5%e35%and 2%e12% of all cancer patients in Japan,respectively.8e13 Psychological distress impairsthe quality of life of cancer patients.14,15

Although psychotherapy and pharmacother-apy are effective in reducing psychological dis-tress, the psychological distress is oftenunderrecognized by physicians and other med-ical staff.16,17 Thus, recent guidelines recom-mend screening for psychological distress inall cancer patients.18 The Distress Thermome-ter (DT) is a validated screening tool for clini-cally significant distress.19e21 However, ourprevious study showed that the DT score maychange on sequential measurements and maybe strongly influenced by physical symptomsin an outpatient chemotherapy setting.22 TheImpact Thermometer (IT) is a screening toolthat evaluates impact of distress on daily life ac-tivities, and the combination of the IT with theDT showed higher specificity with preservedsensitivity in the screening of clinically signifi-cant psychological distress than using theDT alone.23 Thus, we developed a symptomassessment questionnaire that included boththe DT and IT.

The aim of this study was to clarify thelongitudinal changes in distress evaluated bythe use of the combined DT and IT (DIT);and examine the effects of coexisting physicalsymptoms thereon in an outpatient chemo-therapy setting.

Patients and MethodsThis longitudinal observational study was

a retrospective analysis of prospectively col-lected data. The study subjects were all adultcancer patients scheduled to undergo outpa-tient chemotherapy for any type of malignancyat a general hospital that is also a regionalcancer center in the city of Hamamatsu,Japan. At the time of each hospital visit for che-motherapy, the nurses distributed a self-reportquestionnaire before the start of chemother-apy, instructed the patients on how to com-plete the questionnaire, and asked theparticipants to answer the questions. Thisintervention was part of the usual clinical prac-tice. We collected the data obtained on theinitial visit during the study period and on a fol-low-up visit one to three weeks after the initialvisit. Demographic and medical data, such asage, sex, and primary cancer site, were retro-spectively obtained from the medical charts.The patients were enrolled in the studybetween May and November 2008.

The institutional review board of our hospi-tal approved the ethical and scientific validityof a retrospective analysis of the questionnairedata obtained as part of routine clinical activi-ties. All patients gave written consent that theirclinical information could be used for clinicalresearch.

QuestionnaireWedeveloped the questionnaire based on ex-

isting validated instruments. The questionnaireincluded the following: 1) 0e10 numerical rat-ing scales for seven physical symptoms (pain,somnolence, fatigue, dyspnea, appetite loss,abdominal distention, and nausea) adoptedfrom the Japanese version of the M.D. Ander-son Symptom Inventory,24 2) the DT (a one-itemquestionnaire with an 11-point Likert scaleexamining psychological distress, ranging fromzero to 10 and with a higher score indicatinggreater distress), and 3) the IT (a one-item

Page 3: Longitudinal Follow-Up Study Using the Distress and Impact Thermometer in an Outpatient Chemotherapy Setting

Table 1Patient Characteristics (n¼ 297)

Characteristic n (%)

Age (�SD), years 64.9� 11.1

SexMale 169 (57.1)Female 127 (42.9)

Primary siteLung 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)

SD¼ standard deviation.Some data do not add up to 100% because of missing values.

238 Vol. 43 No. 2 February 2012Yamaguchi et al.

questionnaire with an 11-point Likert scale ex-amining the impact of psychological distresson daily living activities, ranging from zero to10 and with a higher score indicating a lessfavorable status).19,23

Statistical AnalysisWe identified all the patients who had a DIT

score above the cutoff for moderate and severedistress at the initial visit. We used a cutoff pointof 4 on the DTand 3 on the IT formoderate dis-tress and 5 on the DTand 4 on the IT for severedistress, which were reported as the cutoffpoints for major depression and/or adjustmentdisorder and major depression alone, respec-tively, in previous research.23 Then, we classi-fied them into two groups as follows: thosewhose DIT score remained above the cutoff(sustained distress group) and another groupwhose score dropped below the cutoff(improved distress group) at the follow-up visit.We compared the demographic data and inten-sities of the coexisting physical symptomsbetween the sustained distress group and theimproved distress group. For comparison pur-poses, we defined severe and moderate intensi-ties for five physical symptoms (pain, fatigue,dyspnea, appetite loss, and nausea) based onthe results of previous research as follows:pain, 2e4 for moderate and 5e10 for severe;fatigue, 2e4 and 5e10; dyspnea, 3e6 and7e10; appetite loss, 4e6 and 7e10; and nausea,4e6 and 7e10.25 For the other symptoms (som-nolence and abdominal distention), we adop-ted the definitions for moderate and severe as4e6 and 7e10, respectively, based on the resultsof previous research.22 We defined patients ashaving severe physical symptoms if they hadone or more severe symptoms of pain, somno-lence, fatigue, dyspnea, appetite loss, abdomi-nal distention, or nausea.

To adjust for confounding factors affectingchanges in physical symptom intensity, we as-sessed the longitudinal change in their distressevaluated by DIT in patients who did not haveany severe physical symptoms at the initial visit.

Statistical analyses were performed by usingMann-Whitney U tests for assessing continuousvariables and Chi-square tests or Fisher’s exacttests for assessing categorical variables, whereappropriate. For the statistical analysis, weused SPSS for Windows, version 19.0 (IBMJapan Institute, Tokyo, Japan).

ResultsPatient CharacteristicsDuring the study period, 302 patients re-

ceived outpatient chemotherapy; five patientsdid not complete the questionnaire (compli-ance rate, 98%). In total, 297 patients com-pleted the questionnaire at the initial andfollow-up visits. The mean interval betweenthe initial and follow-up visits was 11.9� 4.9days. Table 1 summarizes the backgroundcharacteristics of the eligible patients.

Longitudinal Change in Distress Evaluated bythe DITOf the 297 patients, 109 (36.7%) had moder-

ate or severe distress (DITscore above the cutofffor moderate distress) and 85 patients (28.6%)had severe distress (DIT score above the cutofffor severe distress) at the initial visit (Fig. 1).Of the 109 patients with moderate or severe dis-tress at the initial visit, 51 patients (46.8%) im-proved their distress (DIT score below thecutoff for moderate distress) at the follow-upvisit. Among the 58 patients who sustained theirdistress, 82.8% (44 of 58) of the patients hadone ormore severe physical symptoms. Further-more, of the 85 patients above with severe dis-tress at the initial visit, 37 patients (43.5%)improved their distress at the follow-up visit.Also, among the 48 patients who sustained theirdistress, 79.2% (38 of 48) of the patients hadone or more severe physical symptoms. Among188 patients who had a DIT score below thecutoff for moderate distress at the initial visit,

Page 4: Longitudinal Follow-Up Study Using the Distress and Impact Thermometer in an Outpatient Chemotherapy Setting

At initial assessment At follow-up

Moderate or severe

distress

( n = 109)

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.

Vol. 43 No. 2 February 2012 239Longitudinal Changes in the Distress and Impact Thermometer

172 patients (91.5%) still had a score belowthe cutoff.

Change in Distress Evaluated by DIT andPhysical Symptom Intensity

Table 2 shows a comparison of the demo-graphic data and physical symptom intensitiesamong patients with sustained distress andimproved distress. Among the patients withmoderate or severe distress at the initial visit,no significant differences in the demographicdata or all the physical symptom intensities atthe initial visit, except for pain, dyspnea, andfatigue, were observed between the patientswho sustained their distress and those whoimproved their distress at the follow-up visit.At the follow-up visit, the intensities of four

physical symptoms were significantly higheramong the patients with sustained distressthan 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 tendedto have a higher intensity among the patientswith sustained distress: dyspnea (P¼ 0.149),nausea (P¼ 0.123), and abdominal distention(P¼ 0.267).

Similarly, among the patients with severedistress at the initial visit, no significant differ-ences in the demographic data or all the phys-ical symptom intensities at the initial visit,except for pain and dyspnea, were observedbetween the patients who sustained theirdistress and those who improved their distressat the follow-up visit. At the follow-up visit, the

Page 5: Longitudinal Follow-Up Study Using the Distress and Impact Thermometer in an Outpatient Chemotherapy Setting

Table 2Comparison of Patients Who Sustained Distress and Improved Distress at Follow-Up

At Follow-Up

Patients With Moderate or Severe Distress atInitial Visit (n¼ 109)

Patients With Severe Distress at Initial Visit(n¼ 85)

Sustained Distress(n¼ 58)

Improved Distress(n¼ 51) P-value

SustainedDistress (n¼ 48)

ImprovedDistress (n¼ 37) P-value

Age (�SD), years 68.1� 8.9 64.5� 12.5 0.090 67.5� 9.0 65.4� 12.2 0.314

Sex, n (%)Male 34 (58.6) 28 (54.9) 0.704 31 (59.6) 31 (54.4) 0.699Female 24 (41.4) 23 (45.1) 21 (40.4) 26 (45.6)

Initial visit, mean� SDPain 4.6� 3.1 2.9� 2.9 0.008 6.0� 3.4 3.8� 4.8 0.014Dyspnea 3.1� 2.9 1.8� 2.0 0.040 3.9� 3.5 2.8� 3.1 0.017Nausea 1.8� 2.4 2.0� 2.5 0.744 2.5� 3.1 1.8� 3.0 0.360Appetite loss 3.9� 3.0 3.8� 3.0 0.699 5.0� 2.9 6.6� 4.7 0.662Abdominal distention 2.7� 2.7 2.1� 2.3 0.325 3.3� 2.9 2.5� 3.8 1.000Fatigue 4.9� 2.6 3.9� 2.9 0.035 6.4� 2.3 8.3� 1.5 0.085Somnolence 3.5� 2.7 2.5� 2.4 0.066 4.5� 2.5 4.5� 3.1 0.209

Follow-up visit, mean� SDPain 4.6� 3.1 2.4� 2.3 <0.001 5.6� 3.2 3.0� 3.1 0.001Dyspnea 2.9� 3.1 1.7� 2.1 0.149 3.5� 3.6 1.6� 2.6 0.021Nausea 1.5� 2.1 0.8� 1.5 0.123 1.5� 2.2 0� 0 0.051Appetite loss 4.0� 2.7 1.9� 2.2 <0.001 4.6� 2.4 2.2� 3.9 <0.001Abdominal distention 2.9� 2.9 2.2� 2.6 0.267 3.4� 3.1 0.4� 0.5 0.114Fatigue 4.5� 2.6 2.7� 2.2 <0.001 5.8� 2.3 1.0� 0.8 <0.001Somnolence 3.6� 2.7 1.8� 1.9 <0.001 4.1� 2.4 2.8� 3.3 0.009

240 Vol. 43 No. 2 February 2012Yamaguchi et al.

intensities of five physical symptoms were sig-nificantly higher among the patients withsustained distress: pain (P¼ 0.001), dyspnea(P¼ 0.021), appetite loss (P< 0.001), fatigue(P< 0.001), and somnolence (P¼ 0.009).Two other physical symptoms tended to havea higher intensity among the patients withsustained distress: nausea (P¼ 0.051) andabdominal distention (P¼ 0.114).

Change in Distress Evaluated by the DITAmong Patients Without Severe PhysicalSymptoms

Fig. 2 shows the longitudinal change in dis-tress evaluated by the DIT of a subgroup ofpatients who did not have any severe physicalsymptoms at the initial visit. Twenty-ninepatients had moderate or severe distress, and19 patients had severe distress at the initial visitin this subgroup. Among the 29 patients withmoderate or severe distress, 20 patients(69.0%) improved their distress. Among the19 patients with severe distress, 13 patients(68.4%) improved their distress.

DiscussionThis is, to the best of our knowledge, the first

study to examine longitudinal changes in

distress evaluated by the combination of theIT with the DT in an outpatient chemotherapysetting. This study had three major findings.The first was the longitudinal follow-up datafor distress evaluated by the DIT of patientstreated in an outpatient chemotherapy setting.We previously reported that the DT scores ofmost patients in this setting changed withina few weeks.22 Adding the IT to the DT, withthe initial intention of increasing the specificityof the screening for psychological distress,demonstrated that the DIT scores changedfrom above the cutoff to below after a meanduration of 11 days in about half of thepatients. This finding indicates that the use ofa single DIT for the screening of psychologicaldistress would result in overscreening. And,in this setting, referring all the patients witha singleDITscore above the cutoff to the psychi-atry department may result in a heavy burdenfor not only psychiatrists but also for thepatients because many patients generallyhave a negative attitude toward psychiatryreferral.26,27 This result suggests that referringall patients who have a single positive DITscreening result is not practical because theDIT scores of many patients will change withina short interval; thus, a more practical screen-ing method is needed.

Page 6: Longitudinal Follow-Up Study Using the Distress and Impact Thermometer in an Outpatient Chemotherapy Setting

At initial a s ses s m ent At f o llow-up

Severe distress

( n = 19)

Sustained distress

( n = 6)

Improved distress

( n = 13)

Moderate or severe

distress

( n = 29 )

Sustained distress

( n = 9)

Improved distress

( n = 20)

Fig. 2. Change in the distress evaluated by the DIT of patients who did not have any severe physical symptoms.

Vol. 43 No. 2 February 2012 241Longitudinal Changes in the Distress and Impact Thermometer

A second major finding of this study wasthe significant and clinically interpretable as-sociation between sustained distress abovethe cutoff and the intensities of physicalsymptoms. In this study, most patients withsustained distress had one or more severephysical symptoms. Furthermore, the patientswith sustained distress tended to have higherintensities for all the physical symptoms at thefollow-up visit. These findings suggest that thechange in the physical symptom intensity mayaffect the rapid change in status of the dis-tress evaluated by the DIT. How to handle re-lated physical symptoms during the diagnosisof mood disorders in patients with physical ill-ness remains an unsolved problem.28 Thus,this finding strongly indicates that physiciansshould note that a high DIT score is not sim-ply an indicator of psychiatric comorbidity,and they should interpret the DIT score whiletaking changes in physical symptom intensityinto consideration.

A third major finding was the clarification ofthe longitudinal changes in the status of thedistress evaluated by the DIT among patientswho did not have any severe physical symp-toms. In this study, we examined patientswho did not have any severe physical symptomsat the initial visit to remove the influence ofchanges in physical symptom intensity. Evenwithin this population, the DIT score droppedto below the cutoff point at the follow-up visit

in about 70% of the patients with a DIT scoreabove the cutoff point at the initial visit. A pos-itive DIT score, thus, may indicate that thepatient has a certain psychological status, butnot necessarily a definite psychiatric disorder,that may change even without the influenceof physical symptoms. This finding suggeststhat physicians should not consider referringall patients with a single positive result topsychiatrists but rather should follow the scorelongitudinally when using the DIT to screenfor psychological distress.

The present study has some limitations.First, as this study was limited to that of anoutpatient chemotherapy setting and exam-ined patients with heterogeneous primarysites, these results cannot be automaticallygeneralized to a specific population. How-ever, we believe that this limitation is nota critical flaw because a useful system thatcan be used to screen for psychological dis-tress in a heterogeneous outpatient chemo-therapy setting is needed. Second, this studywas conducted at a single institution. We be-lieve, however, that the results can be gener-alizable to other institutions because ourinstitution functions as a typical regional gen-eral hospital.

In conclusion, although the DIT may bea useful tool for monitoring psychologicaldistress, its score can be influenced by coexist-ing physical symptoms and may change

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242 Vol. 43 No. 2 February 2012Yamaguchi et al.

sequentially within a short time interval in anoutpatient chemotherapy setting. Because theoptimal interval for the reevaluation of theDIT and timing of referral to a psychiatristhave not been explored, further study isneeded to determine the appropriate usageof the DIT for the screening and monitoringof psychological distress in an outpatientchemotherapy setting. A promising methodto be tested in a future study includes a long-term follow-up of the distress evaluated bythe DIT with a diagnostic interview conductedby an experienced psychiatrist.

Disclosures and AcknowledgmentsThe authors declare no conflicts of interest.

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