HEALTH PSYCHOLOGY, 1992,11(4), 250-256 Copyright © 1992, Lawrence Erlbaum Associates, Inc.
Comparing the Effectiveness of Behavioral Treatment for Chemotherapy-Induced Nausea and Vomiting When Administered by Oncologists, Oncology Nurses, and Clinical Psychologists Gary R. Morrow University ofRochester Cancer Center
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Robert Asbury and Sharon Hammon The Genesee Hospital
Patricia Dobkin McGill University
Libby Caruso and Kishan Pandya St. Mary's Hospital
Susan Rosenthal Rochester General Hospital Adequate control of side effects during medical treatment of cancer increases patient compliance and quality of life. Antiemetic drugs are not an effective treatment for the one in three cancer patients on chemotherapy who experience anticipatory nausea and vomiting (ANV); the behavioral treatment of systematic desensitization has been found effective for ANV when delivered by clinical psychologists. This study examined the effectiveness of systematic desensitization when delivered by medical personnel versus clinical psychologists. Seventy-two consecutive cancer patients with ANV were randomly assigned to no-treatment control or to systematic desensitization from 5 behaviorally trained clinical psychologists, 6 clinical oncologists, or 10 oncology nurses. The treatment was found effective in reducing anticipatory nausea, anticipatory vomiting, posttreatment nausea, and posttreatment vomiting compared to control patients, with no significant differences in effectiveness found between clinical psychologists and oncology staff. Although medical personnel should not engage patients in psychotherapy or other interventions that cannot be completed successfully, they can treat patients effectively with systematic desensitization and should be encouraged to learn and use this and other behavioral intervention techniques to benefit total patient care. Key words: nausea, cancer, behavioral treatment, side effects, chemotherapy
The treatment of cancer by the repeated administration of chemotherapy drugs continues to be a significant challenge to the coping of the cancer patient (Morrow, 1989a). Among the most persistent, frequent, and undesirable side effects of chemotherapy drug administration are nausea and vomiting (Lindley, Bernard, & Fields, 1989). Along with being a wholly unpleasant experience, nausea and vomiting increase anxiety and depression; significantly disrupt the activities of daily living and the daily functioning of cancer patients; and promote other treatment complications such as metabolic imbalance, dehydration, and anorexia (Burish & Carey, 1986; Hoagland, Morrow, Bennett, & Carnrike, 1983; Laszlo, 1983; Morrow, 1989b). Adequate management of treatment morbidity maximizes potentially curative treatment (Burish & Carey, 1986; Hoagland et al., 1983; Laszlo, 1983; Morrow, 1989b; Richardson, Shelton, Krailo, & Levine, 1990). Despite the introduction of new pharmacologic agents, up to 60% of cancer patients treated with
Requests for reprints should be sent to Gary R. Morrow, Behavioral Medicine Unit, Cancer Center, University of Rochester School of Medicine and Dentistry, Box 704,601 Elmwood Avenue, Rochester, NY 14642.
chemotherapy drugs continue to experience nausea and vomiting during a course of treatment (Morrow, 1989a; Morrow, Arseneau, Asbury, Bennett, & Boros, 1982; Richardson et al., 1990). The adequate management of chemotherapy-induced nausea and vomiting is critical to cancer patient compliance with treatment regimens and quality of life during treatment (Hoagland et al., 1983; Penta, Poster, & Bruno, 1983; Taylor, Lichtman, & Wood, 1984). We and others have found that approximately one in three chemotherapy patients develops nausea and vomiting in anticipation of a treatment (Burish, Carey, Redd, & Krozely, 1983; Morrow & Dobkin, 1988; Redd, 1989). Antiemetic drugs are ineffective in treating this anticipatory nausea and vomiting (ANV; Burish et al., 1983; Carey & Burish, 1988; Morrow, 1989a). The behavioral intervention of systematic desensitization is an effective treatment for ANV (Blum, 1988; Morrow, 1984; Morrow & Morrell, 1982). Although effective, this treatment has typically been administered by specially trained and experienced behavioral psychologists. Previous controlled studies have suggested that experienced therapists are more effective in treating conditioned side effects such as nausea and vomiting than professionals trained specifically for this task (Carey & Burish, 1987). Yet such consultants may not be readily available in a majority of oncology treatment situations. Because
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BEHAVIORAL TREATMENT FOR NAUSEA AND VOMITING most patient care is delivered by medical personnel, a better understanding of the effectiveness of behavioral treatments implemented by medical personnel is needed. There may be many reasons why medical personnel responsible for patient treatment and care might differ from behavioral psychologists in their ability to deliver behavioral interventions. There are differences in the amount of time spent with patients, the perceived goals of the clinician-patient interactions, and the content and quality of the interactions. Also, medical personnel have been shown to be conditioned stimuli for treatment side effects (Morrow, Lindke, & Black, 1991), and having them implement behavioral interventions designed to reduce those side effects may mediate those conditioned effects. In addition, as medical personnel implement behavioral interventions, they may alter specific aspects of medical treatment due to a better understanding of patient needs. Here we report a randomized clinical trial designed with two principal aims: (a) to assess if medical personnel could use systematic desensitization as effectively as behaviorally trained clinical psychologists and (b) to expand previous research by examining the potential effectiveness of systematic desensitization in treating chemotherapy-induced posttreatment nausea and vomiting (PNV).
METHOD Criteria for Entry Seventy-five consecutive cancer patients receiving multiple infusions of chemotherapeutic drugs as their only treatment for histologically confirmed cancer who reported ANV before their second and third chemotherapy treatments were entered. All were outpatients at one of three geographically separate hospitals of the University of Rochester Cancer Center; previous studies conducted by our group have found no differences in frequency or severity of ANV or PNV among these hospitals. Two successive experiences of ANV were required to ensure stable baseline measurements (Morrow, 1984). All patients were also experiencing PNV. Patients with clinical evidence of metastatic disease of the brain or obstruction of the alimentary canal were excluded (Penta et al., 1983). Protocol
The purpose and procedures of the randomized trial were thoroughly explained to eligible patients, and their written informed consent was obtained. The experimental plan was a randomized, three-group design with each patient studied over four successive chemotherapy infusions. The two baseline assessments were completed following the patients' second and third chemotherapy infusions. The two follow-up assessments were made following the patients' fourth and fifth chemotherapy infusions. Patients were randomized to two treatment groups and one control group. Experimental group patients received systematic desensitization between their third and fourth treatments administered by 1 of 5 clinical psychologists experienced in behavioral treatments or administered by 1 of 6 clinical oncologists or 10 oncology nurses trained in the use of systematic desensitization. All patients received standard clinical care. To (a) maximize the number of patients who received the potentially effective treatment and (b) enhance power in being able to detect statistical differences between the two intervention groups
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(Horowitz, Inouye, & Siegelman, 1979; Hsu, 1989; Miller, 1985), twice as many patients were randomized to each intervention group than to the control group. Previous research has shown that ANV does not improve spontaneously or by antiemetic drug treatment. Therapists were sequentially assigned based on clinic schedule. All therapists in each of the two treatment groups treated at least one patient. Oncologists and oncology nurse therapists were trained using a common format. They reviewed background information and scientific articles on the theory and practice of systematic desensitization; viewed a videotape of a cancer patient being treated by systematic desensitization; reviewed a written script detailing the procedures; experienced the relaxation by undergoing the procedure themselves; practiced by relaxing the senior author (Morrow) and receiving detailed feedback; and practiced by relaxing a nonstudy patient and receiving feedback before treating study patients. Typically, training took about 3 hr. Treatment Groups
Systematic desensitization. Patients in each of the two experimental groups were treated with systematic desensitization. This is a standardized behavioral technique with well-developed methods that has been widely applied for altering maladaptive learned responses (Paul, 1966). Its basic principle is the counterconditioning of an incompatible response (e.g., relaxation) to stimuli or events that elicit maladaptive responses (e.g., nausea and vomiting; Bernstein & Borkevec, 1973). In the case of ANV, it has been shown that these maladaptive side effects can be elicited by stimuli associated with chemotherapy treatment, such as driving to the clinic or seeing the clinic nurse (Andrykowski, Redd, & Hatfield, 1985; Blum, 1988; Morrow & Dobkin, 1988). Recent data have supported the view that similar mechanisms may be involved in the development and expression of PNV (P. B. Jacobsen et al., 1988; Morrow, 1989a). Patients treated by systematic desensitization met with the experimenter in a room apart from the cancer center for two 1-hr sessions between their third and fourth chemotherapy treatments and were taught a modified form of Jacobsonian progressive deep-muscle relaxation (Bernstein & Borkevec, 1973). They learned progressive relaxation of the muscles in their hands, forearms, forehead, eyes, mouth, tongue, upper back and shoulders, chest, and stomach. The basic procedure was for patients to tense a particular muscle group until they physically felt the tension, to release the tension while saying "relax" to themselves, and then to focus on how the muscle group felt with less tension. The relaxation procedure took approximately 20 min and was tape-recorded for reliability checks and home practice. Along with their experimenter, patients constructed an individual hierarchy of situations in which the patients progressively experienced increasingly intense anticipatory side effects. Although there was some variation from patient to patient, the typical hierarchy reported was that the anticipatory side effects started the day before a patient came in for treatment, with increasing intensities experienced the evening before, during breakfast of the treatment day, while driving to the clinic for treatment, and upon entering the waiting room for treatment. Once deeply relaxed, patients imagined each of the scenes in their hierarchy, according to standard procedures developed for systematic desensitization (Paul, 1966). The scene was presented for 20 sec while patients imagined it as clearly and with as much detail as they
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were able. They were instructed to then have the imagined scene "dissolve and float away." When the patient reported remaining relaxed while imagining a particular scene for two successive presentations, the next scene in the hierarchy was presented. Each patient was treated individually.
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No-treatment control. A control group received no active study invention beyond completion of the study assessment forms required of all participants. As in previous studies, this group served to control potential effects of minimal attention paid as part of a research study and to control for potential differences in the natural course of anticipatory side effects (N. S. Jacobsen & Baucom, 1977). Evaluation Techniques—Nausea and Vomiting Nausea and vomiting were assessed by patient self-report. Nausea is a subjective phenomenon, and patient self-report assessment has been shown reliable (Carnrike & Carey, 1990; Morrow, 1984; Pater, William, & Erlichman, 1985). The Morrow Assessment of Nausea and Emesis, a clinically validated scale with separate questions on incidence, severity, and duration of ANV and PNV, was used to measure the symptoms (Carnrike & Carey, 1990; Morrow, 1984). Ratings of symptom severity were made using a 6-point interval scale ranging from very mild (1) to intolerable (6). Symptom duration was quantified by the patient writing in the number of hours the symptom lasted. Other Measures Data on selected demographic, clinical, and psychologic variables were gathered to examine the comparability of groups at baseline. The State-Trait Anxiety Inventory was used to assess patient anxiety (Spielberger, Gorsuch, & Lushene, 1968). Treated patients' expectation of results—and the credibility of investigators and treatment—was examined on 100-mm visual analog scales (described in Morrow & Morrell, 1982).
postintervention follow-up measures (ps > .05). Thus, an average of the two baseline measures and an average of the two follow-up measures were used to increase reliability of measures of severity and duration of both nausea and vomiting (Horowitz et al., 1979; Siegel, 1956). Overall, 72 evaluable patients were studied. No significant differences were found among the three study groups on any demographic or clinical characteristics examined, with the exception of sex of patients. A higher proportion of men was found to have been randomized to the no-treatment group than to the oncology-stafftreated group (p < .05). No previous research has found sex of patients to be related to either the development of anticipatory side effects or to treatment effectiveness (Blum, 1988; Burish & Carey, 1986; Burish et al., 1983; Morrow & Dobkin, 1988; Morrow & Morrell, 1982). There were no differences between groups in the number of chemotherapy drugs being given for treatment or in ratings of their emetic potential (Morrow & Morrell, 1982). Changes in Mean Values of Nausea Severity and Duration in the Groups Changes in the three groups in the severity and duration of both anticipatory nausea (AN) and posttreatment nausea (PN) are compared in Figures 1 and 2. Figure 1 presents severity results. Figure 2 presents results for the duration of both AN and PN. In each figure, means and standard errors of the mean are presented for baseline
SEVERITY (hrs)
Moderate - 3 Mild .
None
Overall examination of potential differences among group means on measures of severity and duration were made by repeated-measures analyses of variance (ANOVAs) on the preintervention and postintervention values. Significant results were examined by planned post hoc statistical comparisons of potential differences among mean values. Comparisons of the number of patients in each of the groups reporting improvement provided additional clinically relevant information. Knowing what proportion of patients benefited from a treatment may be of greater use than knowing the average benefit for the entire sample of patients because the average may be unduly influenced by a small number of patients with very large changes in outcome. These comparisons were made by chi-square test or Fisher's exact test as appropriate (Horowitz et al., 1979; Siegel, 1956).
Post Treatment Nausea
ON o Treatmer t (N=14) • 0neology Sta ff Treate d (N = 29) • Psychologist Treated (N = 29)
Severe. 4
Very Mild
Statistical Analyses
Anticipatory Nausea
Intolerable *i
2
1 0~
IASELINE
FOLLOWUP
BASELINE
FOLLOWUP
A S S E S S M E N T PERIOD FIGURE 1 Changes in the severity of AN and PN from baseline to follow-up for the two experimental groups and the one control group (N 12).
DURATION (hrs) 50 40
Anticipatory Nausea ONo Tre atmen t (N=H) • Oncology Staff Treate d (N = 29) • Psycho logist Treated (N=29)
Post Treatment Nausea
1
20 • 10 • n .
RESULTS As in a past clinical trial (Morrow & Morrell, 1982), no statistically significant differences were found between the two preintervention baseline measures of nausea and vomiting or between the two
BASELINE
FOLLOWUP
BASELINE
FOLLOWUP
A S S E S S M E N T PERIOD FIGURE 2 Changes in the duration of AN and PN from baseline to follow-up for the two experimental groups and the one control group (N: 72).
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BEHAVIORAL TREATMENT FOR NAUSEA AND VOMITING
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versus follow-up assessment times for both AN (left panel) and PN (right panel). Results of AN OVA of group means are discussed later. Results of examining the number of patients in each of the groups who reported improvement are presented and discussed in the tables that follow. Nausea severity. Figure 1 shows that baseline values of PN were generally higher for all groups than were baseline values for AN. Patients reported AN to be mild to moderate and PN to be moderate to severe. Repeated-measures ANOVA for differences in group mean measures of nausea severity from pretreatment to posttreatment showed that the groups differed in change across time, F(2, 69) = 4.75, p < .05. Each intervention group experienced a significant decline (ps < .05) relative to the no-treatment group, which remained the same (p > .10). The three study groups were also not equal in reduction of PN, F(2, 69) = 5.23, p < .05. Each intervention group experienced a significant decline relative to the no-treatment group, which remained the same (p > .20). Nausea duration. Results of an ANOVA for differences in group mean measures of duration are shown in Figure 2. The three groups differed in the reduction of AN duration, F(2, 64) = 5.72, p < .05. Both treatment groups were found to have a significantly greater reduction in AN (ps < .05) than the no-treatment group (p > .20). Patients treated by both clinic staff and psychologists experienced a significantly greater reduction in the duration of their PN than did control patients, F(2, 64) = 16.6,/? < .05. There were no significant differences in the reduction of either AN or PN duration between patients treated by clinic staff and patients treated by psychologists (ps>.05). Analyses of covariance using either age or the baseline value as a covariate did not significantly change any of the results. Analyses comparing severity and duration between oncologists and oncology nurses found no significant differences, confirming the initial decision to combine these groups.
Number of Patients With Improvements in the Groups AN. Table 1 summarizes data on the occurrence, severity, and duration of AN and PN in each of the groups at the two follow-up chemotherapy treatments. A consistent pattern of results was found. Significantly fewer patients treated with systematic desensitization by either psychologists or oncology staff reported AN compared with no-treatment patients, x2(4) = 10.1, p < .05. No significant differences in the incidence of AN were found between patients treated by psychologists and patients treated by oncology staff. A larger percent of experimental group patients who had persistent nausea after being treated by systematic desensitization reported a reduction in the severity, x2(4) = 9.7,/? < .05, and duration, / 2 (4) = U.8,p < .05, of AN than did no-treatment control patients. The results were independent of whether psychologists or oncology staff treated the patients. PN. All patients reported PN during both baseline chemotherapy treatments. There were no significant differences among the percents of patients in the three groups who reported no PN at the two follow-up sessions. Significantly more of the patients who continued to experience PN and who were treated by either psychologist or oncology staff with systematic desensitization reported less severe PN than notreatment patients, / 2 (4) = 9.6, p< .05. No significant differences among groups were found in the number of patients who reported a shorter duration of PN. Anticipatory vomiting (AV). Systematic desensitization was also found to be effective in reducing the severity of AV in the 24 patients who experienced AV during baseline measurement. There were no significant differences in the incidence of AV among the three groups at either baseline or follow-up. However, significantly more of the 14 patients who continued to experience AV and who were treated by either psychologist or oncology staff with systematic desensitization reported less severe AV than no-
TABLE 1 Number of Patients in Each Group With Changes in the Incidence, Severity, and Duration of AN and PN at the Two Follow-Up Chemotherapy Treatments Compared to the Two Baseline Treatments Study Group No Treatment*
Incidence (percentage) Severity0 Less severe No change More severe Mean change in severity d Duration0 Shorter No change Longer Mean change in duration*1 Note. N = 92.
Treated by Psychologist*
Treated by Oncology Staffb
AN
PN
AN
PN
14 (100)
12 (86)
20 (69)
27 (93)
15 (52)
21 (72)
2 (14) 8 (57) 4 (29)
+ 0.2
3(25) 3(25) 6(50) + 0.4
13 (65) 4(20) 3(15) -1.4
14 (52) 7(26) 6(22) -1.0
9(60) 4(27) 2(13) -1.1
16 (77) 2 (9) 3(14) -1.4
4 (29) 4 (29) 6 (43) + 6.2 hr
6(50) 2(17) 4(33) + 15.2hr
16 (80) 2(10) 2(40) -5.5 hr
20 (74) 1 (4) 6(22) -28.3 hr
11 (73) 3(20) 1 (7) -8.8 hr
15 (72) 3(14) 3(14) -16.0hr
AN
PN
a n = 14. bn — 29. cValues refer only to patients with persistent AN or persistent PN. dThe average of the two follow-up observations minus the average of the two baseline observations.
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MORROW ETAL. DISCUSSION
treatment patients, x (4) = 12.0, p < .05. Mean changes in severity and duration for each group are shown in Table 1.
Posttreatment vomiting (PV). Among the 52 patients who continued to experience PV, significantly more patients treated with systematic desensitization reported less severe PV than no-treatment patients, % (4) = 14.8, p < .05 (see Table 2). No differences in the percent with reduced duration were found.
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Use of Antiemetics Patients were taking standard prescribed antiemetic medications such as prochlorperazine (Compazine®) or metoclopromide (Reglan®) during the two baseline chemotherapy infusions before entering into the trial as part of normal clinical practice that was not changed for this trial. Eleven of 14 (79%) patients in the no-treatment group, 24 of 29 (83%) in the group treated by clinical psychologists, and 26 of 29 (90%) in the group treated by clinicians reported taking antiemetic medications. The antiemetics failed to control the ANV; ANV developed and continued while patients were taking the antiemetics. Because antiemetic medication is part of standard clinical management, however, it was continued for all patients who wished throughout the two follow-up treatments. Overall, the use of antiemetic medication appeared to have little systematic effect on either anticipatory or posttreatment side effects. There was no interaction between antiemetic drug use and treatment assignment. Other Results The mean level of situational (or state) anxiety was lower at followup than at baseline in each of the three groups; however, no one group had a more significant reduction than another. No significant changes in long-standing (or trait) anxiety, expectation of improvement, or credibility of the desensitization when administered by either treatment group were found.
ANV was reduced by the use of systematic desensitization, as was PNV—despite variable use of pharmacologic antiemetic therapy. This effect was as strong for medical personnel as for psychologists, which is a result inconsistent with previous findings (Carey & Burish, 1987) that experienced behavioral therapists were more effective in treating conditioned side effects than professionals trained specifically for the task. The present study offers some insight for speculation regarding the mechanisms that resulted in nurses and oncologists being as successful as clinical psychologists in treating patients and, in the case of PV, more successful—despite differences in training and other characteristics of the two groups. One possibility is that physicians and nurses were as effective as psychologists because they altered their medical management of the side effects as a result of being part of this research. This possibility is not supported by the data. Approximately the same percentage of patients treated by physicians and nurses were taking antiemetic drugs initially (90%) as the percentage of patients treated by psychologists (83%). In each treatment group, 3 patients who were not taking antiemetics during the baseline period began during the follow-up. However, roughly half as many (4 patients) treated by oncologists and nurses did not take antiemetics during the follow-up as patients treated by psychologists (7 patients). Thus, patients treated by oncologists and nurses may have been more likely to discontinue antiemetic treatment. It is also possible that patients saw the oncology-staff experimenters for a longer period of time and more frequently than they did the psychologist experimenters. Seeing the oncologist and nurse during subsequent chemotherapy treatments in the clinic as part of the usual routine may have reinforced potential effects of the behavioral relaxation, thereby acting as inadvertent "booster" trials. Support for this conjecture awaits further controlled experimental study. Patients may also have become less anxious with their chemotherapy due to increased attention from their health care providers. Anxiety has been shown to be involved in the development and expression of nausea and other chemotherapy side effects (Morrow, in press). That there were no significant differences in anxiety
TABLE 2 Number of Patients in Each Group With Changes in the Incidence, Severity, and Duration of AV and PV at the Two Follow-Up Chemotherapy Treatments Compared to the Two Baseline Treatments Study Group No Treatment*
Incidence (percentage) Severity0 Less severe No change More severe Mean change in severity41 Duration0 Shorter No change Longer Mean change in duration11
Treated by Psychologist*
Treated by Oncology Staff h
AV
PV
AV
PV
AV
PV
3 (100)
10 (71)
6 (60)
24 (83)
5(46)
18 (62)
0 (0) 1 (34) 2 (66) + 0.4
3(30) 0 (0) 7(70) + 0.2
4 (67) 1 (17) 1 (17) -0.6
14 (58) 2 (8) 8(34) -0.4
4(80) 1(20) 0 (0) -0.4
10 (56) 6(33) 2(11) -0.4
0 (0) 1 (34) 2 (66) + 2.1 hr
5(50) 1(10) 3(30) + 13.5 hr
6(100) 0 (0) 0 (0) -6.6 hr
14 (58) 4(16) 6(25) -15.1 hr
4(80) 1(20) 0 (0) -0.5 hr
11 (61) 3(17) 4(22) -10.7 hr
Note. N = 92. a « = 14. bn = 29. °Values refer only to patients with persistent AV or persistent PV. dThe average of the two follow-up observations minus the average of the two baseline observations.
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BEHAVIORAL TREATMENT FOR NAUSEA AND VOMITING
measures between the two groups (or either of the groups compared to the no-treatment control group) casts doubt on this possibility. Studies have suggested that some part of posttreatment chemotherapy side effects may be learned (Morrow et al., 1991). This is consistent with the possibility that clinic personnel could become conditioned stimuli that elicit posttreatment chemotherapy side effects. By becoming actively involved as agents of change, they could become disassociated with eliciting side effects and associated with reducing side effects. Additional issues concern the nonspecific effects of contact with patients and psychologists or clinic staff and possible placebo effects. Although the no-treatment group was designed to control for the potential effects of minimal attention paid to subjects as part of a research study through the filling out of assessment forms, further research might explore the effect of a relaxation intervention compared to an equal amount of patient contact time involving a task such as the discussion of treatment effects. As for placebo effects, in the previous randomized clinical trial by our group (Morrow & Morrell, 1982) and in subsequent studies by others (Burish & Carey, 1986; Burish et al., 1983; Carey & Burish, 1988), patients' expectation for success was not found to be related to outcome. Thus, findings from the behavioral treatment groups are likely to be independent of demand or placebo characteristics. Behavioral intervention for treatment side effects is clinically valuable for several reasons. For anticipatory side effects, the effectiveness of systematic desensitization has been found to be independent of standard pharmacologic antiemetic therapy. A variety of controlled research has shown that increasing the amount of pharmacologic agents given to patients does not control conditioned side effects, but systematic desensitization is effective in doing so. For posttreatment side effects, relaxation and systematic desensitization have been found to be a useful supplement to antiemetic treatment or, in some cases, an alternative. Last, antiemetic drugs frequently have side effects of their own, control of which requires additional drugs. This "polypharmacy" may not be in the patient's best interest. Behavioral interventions have no such side effects. The finding that medical personnel can use systematic desensitization as effectively as trained behavioral consultants for chemotherapy-related nausea and vomiting may encourage medical personnel to learn and successfully use other biobehavioral interventions in a variety of health-related areas. For instance, progressive muscle relaxation has been found effective in modifying health habits such as smoking and obesity (Rodin & Salovey, 1989; Suinn, 1982) and in managing cancer- and disease-related pain (Turner & Chapman, 1982); it also is an important ingredient in stress management programs for both patients and staff (Suinn, 1982). Other behavioral treatments, such as relaxation with guided imagery and hypnosis, have been shown to be effective in reducing cancer-treatment-related distress (Burish et al., 1983; Morrow & Dobkin, 1988; Suinn, 1982). Patient education and familiarization with clinic procedures have also been found to reduce side effects and improve patient coping (Burish, Snyder, & Jenkins, 1991). Such behavioral interventions might be used effectively by a variety of health professionals. However, it is important to note that more in-depth psychological or psychiatric intervention may at times be called for with patients experiencing serious illness. Medical personnel should not attempt psychotherapy or other long-term psychological interventions that they have neither the training nor the time to complete successfully.
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As health care has become more complex, there is a growing realization that a multidisciplinary approach to patient care is essential. The results of this study support this trend: They show that properly trained medical personnel can effectively use an intervention technique derived, developed, and primarily used by the social and behavioral sciences.
ACKNOWLEDGMENTS This research was supported in part by Research Career Development Award K04-CA01038 from the National Cancer Institute, Department of Health and Human Services (DHHS) and in part by National Center for Nursing Research Grant R01-NR01905 from DHHS. Cathy Berendts, RN, Laszlo Boros, MD, Martin Brower, MD, Paul J. Carpenter, PhD, Alex Chang, MD, Sue Cory, RN, Sharon Hyland, RN, Jeffrey Levenkron, PhD, Jacquelynne Lindke, BA, Micki Monaco, RN, Anthony Papciak, PhD, Sue Ratliffe, RN, Lynn Wheland, RN, and Harold Ziesat, PhD, provided invaluable help in carrying out the study. Ms. Barbara Cichetti typed the manuscript.
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Jacobsen, P. B., Andrykowski, M. A., Redd, W. H., Die-Trill, M., Hakes, T. B., Kaufman, R. J., Currie, V. E., & Holland, J. C. (1988). Nonpharmacologic factors in the development of posttreatment nausea with adjuvant chemotherapy for breast cancer. Cancer, 61, 379-385. Laszlo, J. (1983). Emesis as limiting toxicity in cancer chemotherapy. In J. Laszlo (Ed.), Antiemetics and cancer chemotherapy (pp. 1-5). Baltimore: Williams & Wilkins. Lindley, C. M., Bernard, S., & Fields, S. M. (1989). Incidence and duration of chemotherapy-induced nausea and vomiting in the outpatient oncology population. Journal of Clinical Oncology, 7, 1142-1149. Miller, R. (1985). Comparisons. In S. Kotz & N. L. Johnson (Eds.), Encyclopedia of statistical sciences (Vol. 5, pp. 679-689). New York: Wiley. Morrow, G. R. (1984). The assessment of nausea and vomiting: Past problems, current issues, and suggestions for future research. Cancer, 53, 2267-2278. Morrow, G. R. (1989a). Chemotherapy-related nausea and vomiting: Etiology and management. Ca: Journal for Clinicians, 39, 89. Morrow, G. R. (1989b). Chemotherapy side effects and cancer patient nutrition. Nutrition, 5, 119-121. Morrow, G. R. (in press). Learned aspects of chemotherapy induced side effects. British Journal of Oncology. Morrow, G. R., Arseneau, J. C , Asbury, R. F., Bennett, J. M., & Boros, L. (1982). Anticipatory nausea and vomiting with chemotherapy. New England Journal of Medicine, 306, 431-432. Morrow, G. R., & Dobkin, P. L. (1988). Anticipatory nausea and vomiting in cancer patients undergoing chemotherapy treatment: Prevalence, etiology, and behavioral interventions. Clinical Psychology Review, 8, 517556. Morrow, G. R., Lindke, J., & Black, P. M. (1991). Anticipatory nausea development in cancer patients: Replication and extension of a learning model. British Journal of Psychology, 82, 61-72. Morrow, G. R., & Morrell, C. (1982). Behavioral treatment for the anticipa-
tory nausea and vomiting induced by cancer chemotherapy. New England Journal of Medicine, 307, 1476-1480. Pater, J. L., William, A. R., & Erlichman, C. (1985). A validation of self-reported measures of nausea and vomiting. Proceedings of the American Society of Clinical Oncology, 4, 265. Paul, G. L. (1966). Insight versus desensitization in psychotherapy two years after termination. Journal of Consulting and Clinical Psychology, 31, 333-348. Penta, J., Poster, D., & Bruno, S. (1983). The pharmacologic treatment of nausea and vomiting caused by cancer chemotherapy: A review. In J. Laszlo (Ed.), Antiemetics and cancer chemotherapy (pp. 53-92). Baltimore: Williams & Wilkins. Redd, W. H. (1989). Management of anticipatory nausea and vomiting. In J. C. Holland & J. H. Rowland (Eds.), Handbook ofpsychooncology: Psychological care of the patient with cancer (pp. 423-433). New York: Oxford University Press. Richardson, J. L., Shelton, D. R., Krailo, M., & Levine, A. M. (1990). The effect of compliance with treatment on survival among patients with hematologic malignancies. Journal of Clinical Oncology, 8, 356—364. Rodin, J., & Salovey, B. (1989). Health psychology. Annual Review of Psychology, 40, 533-579. Siegel, S. (Ed.). (1956). Non-parametric statistics for the behavioral sciences. New York: McGraw-Hill. Spielberger, C. D., Gorsuch, R. L., & Lushene, R. (1968). The State-Trait Anxiety Inventory (STAI). Palo Alto, CA: Consulting Psychologists Press. Suinn, R. M. (1982). Intervention with Type A behaviors. Journal of Consulting and Clinical Psychology, 50, 797-803. Taylor, S. F., Lichtman, P. R., & Wood, J. V. (1984). Compliance with chemotherapy among breast cancer patients. Health Psychology, 3, 553562. Turner, J. A., & Chapman, C. R. (1982). Psychological interventions for chronic pain: A critical review. Pain, 12, 23-46.
Comparing the Effectiveness of Behavioral Treatment for Chemotherapy-Induced Nausea and Vomiting When Administered by Oncologists, Oncology Nurses, and Clinical Psychologists Gary R. Morrow University ofRochester Cancer Center
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Robert Asbury and Sharon Hammon The Genesee Hospital
Patricia Dobkin McGill University
Libby Caruso and Kishan Pandya St. Mary's Hospital
Susan Rosenthal Rochester General Hospital Adequate control of side effects during medical treatment of cancer increases patient compliance and quality of life. Antiemetic drugs are not an effective treatment for the one in three cancer patients on chemotherapy who experience anticipatory nausea and vomiting (ANV); the behavioral treatment of systematic desensitization has been found effective for ANV when delivered by clinical psychologists. This study examined the effectiveness of systematic desensitization when delivered by medical personnel versus clinical psychologists. Seventy-two consecutive cancer patients with ANV were randomly assigned to no-treatment control or to systematic desensitization from 5 behaviorally trained clinical psychologists, 6 clinical oncologists, or 10 oncology nurses. The treatment was found effective in reducing anticipatory nausea, anticipatory vomiting, posttreatment nausea, and posttreatment vomiting compared to control patients, with no significant differences in effectiveness found between clinical psychologists and oncology staff. Although medical personnel should not engage patients in psychotherapy or other interventions that cannot be completed successfully, they can treat patients effectively with systematic desensitization and should be encouraged to learn and use this and other behavioral intervention techniques to benefit total patient care. Key words: nausea, cancer, behavioral treatment, side effects, chemotherapy
The treatment of cancer by the repeated administration of chemotherapy drugs continues to be a significant challenge to the coping of the cancer patient (Morrow, 1989a). Among the most persistent, frequent, and undesirable side effects of chemotherapy drug administration are nausea and vomiting (Lindley, Bernard, & Fields, 1989). Along with being a wholly unpleasant experience, nausea and vomiting increase anxiety and depression; significantly disrupt the activities of daily living and the daily functioning of cancer patients; and promote other treatment complications such as metabolic imbalance, dehydration, and anorexia (Burish & Carey, 1986; Hoagland, Morrow, Bennett, & Carnrike, 1983; Laszlo, 1983; Morrow, 1989b). Adequate management of treatment morbidity maximizes potentially curative treatment (Burish & Carey, 1986; Hoagland et al., 1983; Laszlo, 1983; Morrow, 1989b; Richardson, Shelton, Krailo, & Levine, 1990). Despite the introduction of new pharmacologic agents, up to 60% of cancer patients treated with
Requests for reprints should be sent to Gary R. Morrow, Behavioral Medicine Unit, Cancer Center, University of Rochester School of Medicine and Dentistry, Box 704,601 Elmwood Avenue, Rochester, NY 14642.
chemotherapy drugs continue to experience nausea and vomiting during a course of treatment (Morrow, 1989a; Morrow, Arseneau, Asbury, Bennett, & Boros, 1982; Richardson et al., 1990). The adequate management of chemotherapy-induced nausea and vomiting is critical to cancer patient compliance with treatment regimens and quality of life during treatment (Hoagland et al., 1983; Penta, Poster, & Bruno, 1983; Taylor, Lichtman, & Wood, 1984). We and others have found that approximately one in three chemotherapy patients develops nausea and vomiting in anticipation of a treatment (Burish, Carey, Redd, & Krozely, 1983; Morrow & Dobkin, 1988; Redd, 1989). Antiemetic drugs are ineffective in treating this anticipatory nausea and vomiting (ANV; Burish et al., 1983; Carey & Burish, 1988; Morrow, 1989a). The behavioral intervention of systematic desensitization is an effective treatment for ANV (Blum, 1988; Morrow, 1984; Morrow & Morrell, 1982). Although effective, this treatment has typically been administered by specially trained and experienced behavioral psychologists. Previous controlled studies have suggested that experienced therapists are more effective in treating conditioned side effects such as nausea and vomiting than professionals trained specifically for this task (Carey & Burish, 1987). Yet such consultants may not be readily available in a majority of oncology treatment situations. Because
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BEHAVIORAL TREATMENT FOR NAUSEA AND VOMITING most patient care is delivered by medical personnel, a better understanding of the effectiveness of behavioral treatments implemented by medical personnel is needed. There may be many reasons why medical personnel responsible for patient treatment and care might differ from behavioral psychologists in their ability to deliver behavioral interventions. There are differences in the amount of time spent with patients, the perceived goals of the clinician-patient interactions, and the content and quality of the interactions. Also, medical personnel have been shown to be conditioned stimuli for treatment side effects (Morrow, Lindke, & Black, 1991), and having them implement behavioral interventions designed to reduce those side effects may mediate those conditioned effects. In addition, as medical personnel implement behavioral interventions, they may alter specific aspects of medical treatment due to a better understanding of patient needs. Here we report a randomized clinical trial designed with two principal aims: (a) to assess if medical personnel could use systematic desensitization as effectively as behaviorally trained clinical psychologists and (b) to expand previous research by examining the potential effectiveness of systematic desensitization in treating chemotherapy-induced posttreatment nausea and vomiting (PNV).
METHOD Criteria for Entry Seventy-five consecutive cancer patients receiving multiple infusions of chemotherapeutic drugs as their only treatment for histologically confirmed cancer who reported ANV before their second and third chemotherapy treatments were entered. All were outpatients at one of three geographically separate hospitals of the University of Rochester Cancer Center; previous studies conducted by our group have found no differences in frequency or severity of ANV or PNV among these hospitals. Two successive experiences of ANV were required to ensure stable baseline measurements (Morrow, 1984). All patients were also experiencing PNV. Patients with clinical evidence of metastatic disease of the brain or obstruction of the alimentary canal were excluded (Penta et al., 1983). Protocol
The purpose and procedures of the randomized trial were thoroughly explained to eligible patients, and their written informed consent was obtained. The experimental plan was a randomized, three-group design with each patient studied over four successive chemotherapy infusions. The two baseline assessments were completed following the patients' second and third chemotherapy infusions. The two follow-up assessments were made following the patients' fourth and fifth chemotherapy infusions. Patients were randomized to two treatment groups and one control group. Experimental group patients received systematic desensitization between their third and fourth treatments administered by 1 of 5 clinical psychologists experienced in behavioral treatments or administered by 1 of 6 clinical oncologists or 10 oncology nurses trained in the use of systematic desensitization. All patients received standard clinical care. To (a) maximize the number of patients who received the potentially effective treatment and (b) enhance power in being able to detect statistical differences between the two intervention groups
251
(Horowitz, Inouye, & Siegelman, 1979; Hsu, 1989; Miller, 1985), twice as many patients were randomized to each intervention group than to the control group. Previous research has shown that ANV does not improve spontaneously or by antiemetic drug treatment. Therapists were sequentially assigned based on clinic schedule. All therapists in each of the two treatment groups treated at least one patient. Oncologists and oncology nurse therapists were trained using a common format. They reviewed background information and scientific articles on the theory and practice of systematic desensitization; viewed a videotape of a cancer patient being treated by systematic desensitization; reviewed a written script detailing the procedures; experienced the relaxation by undergoing the procedure themselves; practiced by relaxing the senior author (Morrow) and receiving detailed feedback; and practiced by relaxing a nonstudy patient and receiving feedback before treating study patients. Typically, training took about 3 hr. Treatment Groups
Systematic desensitization. Patients in each of the two experimental groups were treated with systematic desensitization. This is a standardized behavioral technique with well-developed methods that has been widely applied for altering maladaptive learned responses (Paul, 1966). Its basic principle is the counterconditioning of an incompatible response (e.g., relaxation) to stimuli or events that elicit maladaptive responses (e.g., nausea and vomiting; Bernstein & Borkevec, 1973). In the case of ANV, it has been shown that these maladaptive side effects can be elicited by stimuli associated with chemotherapy treatment, such as driving to the clinic or seeing the clinic nurse (Andrykowski, Redd, & Hatfield, 1985; Blum, 1988; Morrow & Dobkin, 1988). Recent data have supported the view that similar mechanisms may be involved in the development and expression of PNV (P. B. Jacobsen et al., 1988; Morrow, 1989a). Patients treated by systematic desensitization met with the experimenter in a room apart from the cancer center for two 1-hr sessions between their third and fourth chemotherapy treatments and were taught a modified form of Jacobsonian progressive deep-muscle relaxation (Bernstein & Borkevec, 1973). They learned progressive relaxation of the muscles in their hands, forearms, forehead, eyes, mouth, tongue, upper back and shoulders, chest, and stomach. The basic procedure was for patients to tense a particular muscle group until they physically felt the tension, to release the tension while saying "relax" to themselves, and then to focus on how the muscle group felt with less tension. The relaxation procedure took approximately 20 min and was tape-recorded for reliability checks and home practice. Along with their experimenter, patients constructed an individual hierarchy of situations in which the patients progressively experienced increasingly intense anticipatory side effects. Although there was some variation from patient to patient, the typical hierarchy reported was that the anticipatory side effects started the day before a patient came in for treatment, with increasing intensities experienced the evening before, during breakfast of the treatment day, while driving to the clinic for treatment, and upon entering the waiting room for treatment. Once deeply relaxed, patients imagined each of the scenes in their hierarchy, according to standard procedures developed for systematic desensitization (Paul, 1966). The scene was presented for 20 sec while patients imagined it as clearly and with as much detail as they
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MORROW ETAL.
were able. They were instructed to then have the imagined scene "dissolve and float away." When the patient reported remaining relaxed while imagining a particular scene for two successive presentations, the next scene in the hierarchy was presented. Each patient was treated individually.
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No-treatment control. A control group received no active study invention beyond completion of the study assessment forms required of all participants. As in previous studies, this group served to control potential effects of minimal attention paid as part of a research study and to control for potential differences in the natural course of anticipatory side effects (N. S. Jacobsen & Baucom, 1977). Evaluation Techniques—Nausea and Vomiting Nausea and vomiting were assessed by patient self-report. Nausea is a subjective phenomenon, and patient self-report assessment has been shown reliable (Carnrike & Carey, 1990; Morrow, 1984; Pater, William, & Erlichman, 1985). The Morrow Assessment of Nausea and Emesis, a clinically validated scale with separate questions on incidence, severity, and duration of ANV and PNV, was used to measure the symptoms (Carnrike & Carey, 1990; Morrow, 1984). Ratings of symptom severity were made using a 6-point interval scale ranging from very mild (1) to intolerable (6). Symptom duration was quantified by the patient writing in the number of hours the symptom lasted. Other Measures Data on selected demographic, clinical, and psychologic variables were gathered to examine the comparability of groups at baseline. The State-Trait Anxiety Inventory was used to assess patient anxiety (Spielberger, Gorsuch, & Lushene, 1968). Treated patients' expectation of results—and the credibility of investigators and treatment—was examined on 100-mm visual analog scales (described in Morrow & Morrell, 1982).
postintervention follow-up measures (ps > .05). Thus, an average of the two baseline measures and an average of the two follow-up measures were used to increase reliability of measures of severity and duration of both nausea and vomiting (Horowitz et al., 1979; Siegel, 1956). Overall, 72 evaluable patients were studied. No significant differences were found among the three study groups on any demographic or clinical characteristics examined, with the exception of sex of patients. A higher proportion of men was found to have been randomized to the no-treatment group than to the oncology-stafftreated group (p < .05). No previous research has found sex of patients to be related to either the development of anticipatory side effects or to treatment effectiveness (Blum, 1988; Burish & Carey, 1986; Burish et al., 1983; Morrow & Dobkin, 1988; Morrow & Morrell, 1982). There were no differences between groups in the number of chemotherapy drugs being given for treatment or in ratings of their emetic potential (Morrow & Morrell, 1982). Changes in Mean Values of Nausea Severity and Duration in the Groups Changes in the three groups in the severity and duration of both anticipatory nausea (AN) and posttreatment nausea (PN) are compared in Figures 1 and 2. Figure 1 presents severity results. Figure 2 presents results for the duration of both AN and PN. In each figure, means and standard errors of the mean are presented for baseline
SEVERITY (hrs)
Moderate - 3 Mild .
None
Overall examination of potential differences among group means on measures of severity and duration were made by repeated-measures analyses of variance (ANOVAs) on the preintervention and postintervention values. Significant results were examined by planned post hoc statistical comparisons of potential differences among mean values. Comparisons of the number of patients in each of the groups reporting improvement provided additional clinically relevant information. Knowing what proportion of patients benefited from a treatment may be of greater use than knowing the average benefit for the entire sample of patients because the average may be unduly influenced by a small number of patients with very large changes in outcome. These comparisons were made by chi-square test or Fisher's exact test as appropriate (Horowitz et al., 1979; Siegel, 1956).
Post Treatment Nausea
ON o Treatmer t (N=14) • 0neology Sta ff Treate d (N = 29) • Psychologist Treated (N = 29)
Severe. 4
Very Mild
Statistical Analyses
Anticipatory Nausea
Intolerable *i
2
1 0~
IASELINE
FOLLOWUP
BASELINE
FOLLOWUP
A S S E S S M E N T PERIOD FIGURE 1 Changes in the severity of AN and PN from baseline to follow-up for the two experimental groups and the one control group (N 12).
DURATION (hrs) 50 40
Anticipatory Nausea ONo Tre atmen t (N=H) • Oncology Staff Treate d (N = 29) • Psycho logist Treated (N=29)
Post Treatment Nausea
1
20 • 10 • n .
RESULTS As in a past clinical trial (Morrow & Morrell, 1982), no statistically significant differences were found between the two preintervention baseline measures of nausea and vomiting or between the two
BASELINE
FOLLOWUP
BASELINE
FOLLOWUP
A S S E S S M E N T PERIOD FIGURE 2 Changes in the duration of AN and PN from baseline to follow-up for the two experimental groups and the one control group (N: 72).
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BEHAVIORAL TREATMENT FOR NAUSEA AND VOMITING
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versus follow-up assessment times for both AN (left panel) and PN (right panel). Results of AN OVA of group means are discussed later. Results of examining the number of patients in each of the groups who reported improvement are presented and discussed in the tables that follow. Nausea severity. Figure 1 shows that baseline values of PN were generally higher for all groups than were baseline values for AN. Patients reported AN to be mild to moderate and PN to be moderate to severe. Repeated-measures ANOVA for differences in group mean measures of nausea severity from pretreatment to posttreatment showed that the groups differed in change across time, F(2, 69) = 4.75, p < .05. Each intervention group experienced a significant decline (ps < .05) relative to the no-treatment group, which remained the same (p > .10). The three study groups were also not equal in reduction of PN, F(2, 69) = 5.23, p < .05. Each intervention group experienced a significant decline relative to the no-treatment group, which remained the same (p > .20). Nausea duration. Results of an ANOVA for differences in group mean measures of duration are shown in Figure 2. The three groups differed in the reduction of AN duration, F(2, 64) = 5.72, p < .05. Both treatment groups were found to have a significantly greater reduction in AN (ps < .05) than the no-treatment group (p > .20). Patients treated by both clinic staff and psychologists experienced a significantly greater reduction in the duration of their PN than did control patients, F(2, 64) = 16.6,/? < .05. There were no significant differences in the reduction of either AN or PN duration between patients treated by clinic staff and patients treated by psychologists (ps>.05). Analyses of covariance using either age or the baseline value as a covariate did not significantly change any of the results. Analyses comparing severity and duration between oncologists and oncology nurses found no significant differences, confirming the initial decision to combine these groups.
Number of Patients With Improvements in the Groups AN. Table 1 summarizes data on the occurrence, severity, and duration of AN and PN in each of the groups at the two follow-up chemotherapy treatments. A consistent pattern of results was found. Significantly fewer patients treated with systematic desensitization by either psychologists or oncology staff reported AN compared with no-treatment patients, x2(4) = 10.1, p < .05. No significant differences in the incidence of AN were found between patients treated by psychologists and patients treated by oncology staff. A larger percent of experimental group patients who had persistent nausea after being treated by systematic desensitization reported a reduction in the severity, x2(4) = 9.7,/? < .05, and duration, / 2 (4) = U.8,p < .05, of AN than did no-treatment control patients. The results were independent of whether psychologists or oncology staff treated the patients. PN. All patients reported PN during both baseline chemotherapy treatments. There were no significant differences among the percents of patients in the three groups who reported no PN at the two follow-up sessions. Significantly more of the patients who continued to experience PN and who were treated by either psychologist or oncology staff with systematic desensitization reported less severe PN than notreatment patients, / 2 (4) = 9.6, p< .05. No significant differences among groups were found in the number of patients who reported a shorter duration of PN. Anticipatory vomiting (AV). Systematic desensitization was also found to be effective in reducing the severity of AV in the 24 patients who experienced AV during baseline measurement. There were no significant differences in the incidence of AV among the three groups at either baseline or follow-up. However, significantly more of the 14 patients who continued to experience AV and who were treated by either psychologist or oncology staff with systematic desensitization reported less severe AV than no-
TABLE 1 Number of Patients in Each Group With Changes in the Incidence, Severity, and Duration of AN and PN at the Two Follow-Up Chemotherapy Treatments Compared to the Two Baseline Treatments Study Group No Treatment*
Incidence (percentage) Severity0 Less severe No change More severe Mean change in severity d Duration0 Shorter No change Longer Mean change in duration*1 Note. N = 92.
Treated by Psychologist*
Treated by Oncology Staffb
AN
PN
AN
PN
14 (100)
12 (86)
20 (69)
27 (93)
15 (52)
21 (72)
2 (14) 8 (57) 4 (29)
+ 0.2
3(25) 3(25) 6(50) + 0.4
13 (65) 4(20) 3(15) -1.4
14 (52) 7(26) 6(22) -1.0
9(60) 4(27) 2(13) -1.1
16 (77) 2 (9) 3(14) -1.4
4 (29) 4 (29) 6 (43) + 6.2 hr
6(50) 2(17) 4(33) + 15.2hr
16 (80) 2(10) 2(40) -5.5 hr
20 (74) 1 (4) 6(22) -28.3 hr
11 (73) 3(20) 1 (7) -8.8 hr
15 (72) 3(14) 3(14) -16.0hr
AN
PN
a n = 14. bn — 29. cValues refer only to patients with persistent AN or persistent PN. dThe average of the two follow-up observations minus the average of the two baseline observations.
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MORROW ETAL. DISCUSSION
treatment patients, x (4) = 12.0, p < .05. Mean changes in severity and duration for each group are shown in Table 1.
Posttreatment vomiting (PV). Among the 52 patients who continued to experience PV, significantly more patients treated with systematic desensitization reported less severe PV than no-treatment patients, % (4) = 14.8, p < .05 (see Table 2). No differences in the percent with reduced duration were found.
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Use of Antiemetics Patients were taking standard prescribed antiemetic medications such as prochlorperazine (Compazine®) or metoclopromide (Reglan®) during the two baseline chemotherapy infusions before entering into the trial as part of normal clinical practice that was not changed for this trial. Eleven of 14 (79%) patients in the no-treatment group, 24 of 29 (83%) in the group treated by clinical psychologists, and 26 of 29 (90%) in the group treated by clinicians reported taking antiemetic medications. The antiemetics failed to control the ANV; ANV developed and continued while patients were taking the antiemetics. Because antiemetic medication is part of standard clinical management, however, it was continued for all patients who wished throughout the two follow-up treatments. Overall, the use of antiemetic medication appeared to have little systematic effect on either anticipatory or posttreatment side effects. There was no interaction between antiemetic drug use and treatment assignment. Other Results The mean level of situational (or state) anxiety was lower at followup than at baseline in each of the three groups; however, no one group had a more significant reduction than another. No significant changes in long-standing (or trait) anxiety, expectation of improvement, or credibility of the desensitization when administered by either treatment group were found.
ANV was reduced by the use of systematic desensitization, as was PNV—despite variable use of pharmacologic antiemetic therapy. This effect was as strong for medical personnel as for psychologists, which is a result inconsistent with previous findings (Carey & Burish, 1987) that experienced behavioral therapists were more effective in treating conditioned side effects than professionals trained specifically for the task. The present study offers some insight for speculation regarding the mechanisms that resulted in nurses and oncologists being as successful as clinical psychologists in treating patients and, in the case of PV, more successful—despite differences in training and other characteristics of the two groups. One possibility is that physicians and nurses were as effective as psychologists because they altered their medical management of the side effects as a result of being part of this research. This possibility is not supported by the data. Approximately the same percentage of patients treated by physicians and nurses were taking antiemetic drugs initially (90%) as the percentage of patients treated by psychologists (83%). In each treatment group, 3 patients who were not taking antiemetics during the baseline period began during the follow-up. However, roughly half as many (4 patients) treated by oncologists and nurses did not take antiemetics during the follow-up as patients treated by psychologists (7 patients). Thus, patients treated by oncologists and nurses may have been more likely to discontinue antiemetic treatment. It is also possible that patients saw the oncology-staff experimenters for a longer period of time and more frequently than they did the psychologist experimenters. Seeing the oncologist and nurse during subsequent chemotherapy treatments in the clinic as part of the usual routine may have reinforced potential effects of the behavioral relaxation, thereby acting as inadvertent "booster" trials. Support for this conjecture awaits further controlled experimental study. Patients may also have become less anxious with their chemotherapy due to increased attention from their health care providers. Anxiety has been shown to be involved in the development and expression of nausea and other chemotherapy side effects (Morrow, in press). That there were no significant differences in anxiety
TABLE 2 Number of Patients in Each Group With Changes in the Incidence, Severity, and Duration of AV and PV at the Two Follow-Up Chemotherapy Treatments Compared to the Two Baseline Treatments Study Group No Treatment*
Incidence (percentage) Severity0 Less severe No change More severe Mean change in severity41 Duration0 Shorter No change Longer Mean change in duration11
Treated by Psychologist*
Treated by Oncology Staff h
AV
PV
AV
PV
AV
PV
3 (100)
10 (71)
6 (60)
24 (83)
5(46)
18 (62)
0 (0) 1 (34) 2 (66) + 0.4
3(30) 0 (0) 7(70) + 0.2
4 (67) 1 (17) 1 (17) -0.6
14 (58) 2 (8) 8(34) -0.4
4(80) 1(20) 0 (0) -0.4
10 (56) 6(33) 2(11) -0.4
0 (0) 1 (34) 2 (66) + 2.1 hr
5(50) 1(10) 3(30) + 13.5 hr
6(100) 0 (0) 0 (0) -6.6 hr
14 (58) 4(16) 6(25) -15.1 hr
4(80) 1(20) 0 (0) -0.5 hr
11 (61) 3(17) 4(22) -10.7 hr
Note. N = 92. a « = 14. bn = 29. °Values refer only to patients with persistent AV or persistent PV. dThe average of the two follow-up observations minus the average of the two baseline observations.
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BEHAVIORAL TREATMENT FOR NAUSEA AND VOMITING
measures between the two groups (or either of the groups compared to the no-treatment control group) casts doubt on this possibility. Studies have suggested that some part of posttreatment chemotherapy side effects may be learned (Morrow et al., 1991). This is consistent with the possibility that clinic personnel could become conditioned stimuli that elicit posttreatment chemotherapy side effects. By becoming actively involved as agents of change, they could become disassociated with eliciting side effects and associated with reducing side effects. Additional issues concern the nonspecific effects of contact with patients and psychologists or clinic staff and possible placebo effects. Although the no-treatment group was designed to control for the potential effects of minimal attention paid to subjects as part of a research study through the filling out of assessment forms, further research might explore the effect of a relaxation intervention compared to an equal amount of patient contact time involving a task such as the discussion of treatment effects. As for placebo effects, in the previous randomized clinical trial by our group (Morrow & Morrell, 1982) and in subsequent studies by others (Burish & Carey, 1986; Burish et al., 1983; Carey & Burish, 1988), patients' expectation for success was not found to be related to outcome. Thus, findings from the behavioral treatment groups are likely to be independent of demand or placebo characteristics. Behavioral intervention for treatment side effects is clinically valuable for several reasons. For anticipatory side effects, the effectiveness of systematic desensitization has been found to be independent of standard pharmacologic antiemetic therapy. A variety of controlled research has shown that increasing the amount of pharmacologic agents given to patients does not control conditioned side effects, but systematic desensitization is effective in doing so. For posttreatment side effects, relaxation and systematic desensitization have been found to be a useful supplement to antiemetic treatment or, in some cases, an alternative. Last, antiemetic drugs frequently have side effects of their own, control of which requires additional drugs. This "polypharmacy" may not be in the patient's best interest. Behavioral interventions have no such side effects. The finding that medical personnel can use systematic desensitization as effectively as trained behavioral consultants for chemotherapy-related nausea and vomiting may encourage medical personnel to learn and successfully use other biobehavioral interventions in a variety of health-related areas. For instance, progressive muscle relaxation has been found effective in modifying health habits such as smoking and obesity (Rodin & Salovey, 1989; Suinn, 1982) and in managing cancer- and disease-related pain (Turner & Chapman, 1982); it also is an important ingredient in stress management programs for both patients and staff (Suinn, 1982). Other behavioral treatments, such as relaxation with guided imagery and hypnosis, have been shown to be effective in reducing cancer-treatment-related distress (Burish et al., 1983; Morrow & Dobkin, 1988; Suinn, 1982). Patient education and familiarization with clinic procedures have also been found to reduce side effects and improve patient coping (Burish, Snyder, & Jenkins, 1991). Such behavioral interventions might be used effectively by a variety of health professionals. However, it is important to note that more in-depth psychological or psychiatric intervention may at times be called for with patients experiencing serious illness. Medical personnel should not attempt psychotherapy or other long-term psychological interventions that they have neither the training nor the time to complete successfully.
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As health care has become more complex, there is a growing realization that a multidisciplinary approach to patient care is essential. The results of this study support this trend: They show that properly trained medical personnel can effectively use an intervention technique derived, developed, and primarily used by the social and behavioral sciences.
ACKNOWLEDGMENTS This research was supported in part by Research Career Development Award K04-CA01038 from the National Cancer Institute, Department of Health and Human Services (DHHS) and in part by National Center for Nursing Research Grant R01-NR01905 from DHHS. Cathy Berendts, RN, Laszlo Boros, MD, Martin Brower, MD, Paul J. Carpenter, PhD, Alex Chang, MD, Sue Cory, RN, Sharon Hyland, RN, Jeffrey Levenkron, PhD, Jacquelynne Lindke, BA, Micki Monaco, RN, Anthony Papciak, PhD, Sue Ratliffe, RN, Lynn Wheland, RN, and Harold Ziesat, PhD, provided invaluable help in carrying out the study. Ms. Barbara Cichetti typed the manuscript.
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