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«Patterns of sore mouth in outpatients with cancer receiving chemotherapy. By: Carlton G. Brown, Susan L. Beck, Douglas E. Peterson, Deborah B. ...»

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In the next pattern, onset intensity, patients reported their first complaint of a SM as above a score of 5 on a 1–10 scale. This new and unique finding suggests that for some patients, there is not a gradual increase in SM discomfort over a few days. Instead, SM begins in the moderate range without a slow period of development. This pattern is of particular concern because it may be more difficult to assist patients with pain control when SM is moderate to severe at its first appearance. All graphs sorted into the onset intensity category were evaluated to confirm that the days prior to the first response were not missing days (see Fig. 4); in all instances, the days prior were true SM severity ratings of zero as opposed to missing data.

Approximately half of the patients were coded into the low intensity pattern, defined as a severity response never exceeding 4 on a 1–10 scale. This pattern, along with middle onset, are perhaps two of the most common patterns of SM seen in clinical practice, especially in patients receiving outpatient chemotherapy. Two other patterns included late duration and duration intensity. Approximately one fourth of patients (26%) demonstrated a SM severity response that persisted after day 15 of treatment and was an example of late duration. Other patients (18%) reported a SM after day 15 and rated the SM as being 5 or greater (duration intensity), suggesting that some patients experience a SM lasting well after day 15 and at an intensity higher than 5 on a 1–10 scale. These patients may require more intensive pain intervention.

In addition, during the process of visual graphing, the first author discovered a new pattern of two episodes of SM separated by at least 2 days of no SM (see Fig. 9). This finding represents a unique dynamic that has not been previously described in the literature. Further research using prospective designs is needed to verify if participants actually experience a few days of SM, followed by a few days of no report of a SM, followed by more days of SM. It would be helpful in this instance to use actual measures of OM instead of self-reported SM. If research supports the presence of more than one episode of SM during a cycle, it would be interesting to investigate the correlation of these episodes with potential clinical risk factors such as patient’s nadir, infection, renal function, or dehydration. For instance, when a patient experiences two episodes of SM, are those episodes in congruence with the beginning and end of neutropenia or with some other physiologic event? The detection of this unusual pattern would likely have been missed using traditional statistics, thus highlighting the advantages of VGA.

As previously noted, patients in this study had already received one cycle of chemotherapy prior to study entry. Patients had experienced at least one symptom of moderate intensity in order to be included in the study. Some of the participants during cycle 1 also experienced selected associated symptoms such as nausea, difficulty sleeping, and SM. Therefore, patients may have be more acutely aware of a particular symptom, leading them to report symptoms that occurred earlier and/or later and at a higher intensity following chemotherapy. Additionally, VGA may have helped identify a subset of patients who experienced SM differently than previously understood. By investigating patterns of a symptom individually over time, a new understanding of those patterns is presented.

Findings from this secondary analysis suggest that there are levels of variability in patients’ patterns of SM. No two patients presented with SM (or other symptoms) in exactly the same manner. These findings challenge health care providers and researchers to think differently about patients experiencing SM because not all patients are alike. Thus, assessment and management procedures need more individualization than previously thought. It is imperative for clinicians and researchers to continue vigilant assessment of SM across the entire treatment period. The timing of assessment is important in studies focusing on SM, since studies that only measure the symptom at day 5 or on a weekly basis might miss important data. Thus, oral assessment should occur more frequently, for longer periods of time after treatment, and on a more consistent, daily schedule. Even self-reports can clue the clinician to the need for a more thorough oral exam for full diagnosis and intervention.

Assessment is a particularly challenging endeavor for outpatients because of their nonavailability in between treatments. Clinicians and researchers must think of other innovative techniques to assess outpatients. Assessment tools such as TLC alert or daily questionnaires such as those used by Stiff et al. [18] or Wong et al. [20] that gather information from patients at home might be an answer to meeting this challenge. Another option is to teach patients to do a simple visual inspection of their oral cavity using a simple OM assessment tool and reporting changes in color, ulcerations, etc. It is also important for researchers to report patients’ adherence rates to conducting such exams and reporting the results when these daily questionnaires are used by patients to help determine the feasibility of using the questionnaires in research.

In addition, it is beneficial to assess patterns of SM longitudinally over two or more cycles of chemotherapy to get a more accurate picture of any given patient’s trajectory. Since clinical factors such as chemotherapy regimens and type of cancer seem more important in relation to patterns of SM, increased focus on surveillance and assessment should be included when patients are treated with antineoplastic agents that have been shown in the literature to cause more severe or unusual patterns of SM [5].





Finally, assessment should include particular patient characteristics such as age, marital status, and educational level. Recall that non-married patients were more likely to report early onset of SM. Further research is needed, but it may be that those patients who receive emotional and physical support report SM later and at a lower severity. Thus, there is a need to include particular patient characteristics in clinical assessment and research.

This study demonstrated significant relationships between particular chemotherapy agents and patterns of OM. Amongst participants from this study, the AC regimen was significantly associated with late onset; however, the duration of the onset was not particularly intense. Quite the opposite, patients receiving RCHOP were significantly more likely to experience duration intensity. Interestingly, both regimens contain doxorubicin and cyclophosphamide, yet only those patients receiving R-CHOP got rituximab. Perhaps, rituximab was responsible for the longer duration and intensity of SM. In an extensive study of OM, Sonis et al. [16] noted that grades 3 and 4 OM were seen in approximately 10% of patients receiving a combination of doxorubicin and cyclophosphamide. The regimen CMF was significantly associated with middle onset, while “other” chemotherapy drugs (flurouracil, cisplatin) tended to cause early onset SM.

Future studies should investigate duration, onset, incidence, and intensity of SM in particular chemotherapies. In studies with heterogeneous treatment regimens, it is important to analyze patterns related to treatment.

Another interesting finding was that 97% of participants ranked their daily severity and distress scores within one point or less of each other. There may be at least two reasons why participants rated severity and distress similarly. First, patients may really have felt that severity and distress were very similar. Second, patients may not have understood the conceptual differences between the meaning of the words “severity” and “distress” and may, thus, have viewed them as the same thing. In future studies, it may be helpful to carefully define the words severity and distress to patients so that they can understand what is being asked.

Limitations

This study was limited by several issues. First, the findings from the study are not generalizable beyond the study sample, which consisted primarily of married Caucasian women with some college education and with a diagnosis of breast cancer. Future research should include increased participation by minorities, men, people from other socioeconomic backgrounds, and people with other cancer diagnoses. We also exclude participants who only reported a sore mouth once or twice; some of these patients may have had OM.

Another limitation was the number of cycles each participant received. All participants received one cycle of chemotherapy before beginning the TLC study; recall data from this cycle were used to determine eligibility. Thus, those who had early onset of SM may have been displaying sustained responses related to their prior experience of a SM in cycle 1 of chemotherapy.

Further, it is not known what other clinical interventions occurred during the first cycle of chemotherapy. For instance, a participant who had more intense SM in cycle 1 might have received oral morphine at that time. If this patient continued using oral morphine during cycles 2 and 3, the reported severity and distress could have been less. Because some patients might have received some form of pain medication, the reports are indicative of real life clinical experiences in which some patients may have been treated. Future research should begin in cycle 1 and control for and describe such interventions.

In this secondary analysis, SM was used as a proxy for OM. The assumption was made that a patient receiving chemotherapy who had a complaint of a SM at least three times during a chemotherapy cycle was experiencing OM. However, some patients’ SM may have resulted from other causes, such as dental prostheses. Although this dataset had the advantage of providing daily reports from outpatients who are not readily observable, the ideal study would examine this issue using a prospective repeated-measures design that measured OM using a reliable and valid observational approach.

Finally, because of the exploratory nature of VGA, there are limitations in its use. VGA can be a time-intensive procedure and is appropriate for a smaller sample size when resources are limited.

In this study, although there was an adequate sample based on estimates of five per cell, some categories yielded cell sizes less than expected and the results cannot be considered definitive.

However, this exploratory analysis indicates that trajectories of sore mouth do vary by individual, and differences in trajectory may be related to treatment regimen and/or type of cancer. These findings are important to consider in the design of future studies.

Conclusions This secondary data analysis provides clinicians and researchers with a technique to visualize the trajectory of a symptom over time. It documents a highly variable pattern of SM in patients receiving chemotherapy. It is important to understand a patient’s unique response in order to develop an appropriate assessment and treatment strategy. While health care providers may have witnessed one or many of the patterns of SM in their clinical practice, until now, there has been a lack of actual descriptive research that documented these patterns. Better understanding of the multifaceted problem of SM will ultimately lead to improved interventions to both alleviate and lessen the debilitative effects of OM and allow for the support of patients throughout the entire course of OM, not just when their pain is so intense that they cannot eat or drink or tolerate further cancer therapy. The improved understanding of the complex symptom of mucositis will ultimately improve the overall patient experience and allow patients to receive the chemotherapy they need for a chance at long-term control and cure of their respective cancers.

Acknowledgments

This research was supported in part by the American Cancer Society Doctoral Scholarship #DSCN-03-203-01 and National Cancer Institute, R25 CA093831. The parent study “TelephoneLinked Care for Symptom Management” (K. Mooney, PI) 1 R01 CA89474, funded) was funded by the NCI.

References Brown CG, McGuire DB, Peterson DE, Beck SL, Mooney K (2007) Visual graphical analysis: a technique to investigate symptom trajectories over time. Nurs Res 56:195–201, doi:10.1097/01.NNR.0000270029.82736.5a Chang VT, Hwang SS, Feuerman M, Kasimis BS (2000) Symptom and quality of life survey of medical oncology patients at a Veterans Affairs Medical Center: a role for symptom assessment.

Cancer 88:1175, doi:10.1002/(SICI)1097-0142(20000301)88:51175::AID-CNCR303.0.CO;2N Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M et al (2000) Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer 89(7):1634–1646, doi:10.1002/1097-0142(20001001)89:71634::AID-CNCR293.0.CO;2-V Dodd MJ, Larson PJ, Dibble SL, Miaskowski C, Greenspan D, MacPhail L et al (1996) Randomized clinical trial of clorhexidine versus placebo for prevention for oral mucositis in patients receiving chemotherapy. Oncol Nurs Forum 23:921–927 Elting LS, Cooksley C, Chambers M, Cantor SB, Manzullo E, Rubenstein EB (2003) The burdens of cancer therapy. Clinical and economic outcomes of chemotherapy-induced mucositis.

Cancer 98:1531–1539, doi:10.1002/cncr.11671 McGuire DB, Altomonte V, Peterson DE, Wingard JR, Jones RJ, Grochow LB (1993) Patterns of mucositis and pain in patients receiving preparative chemotherapy and bone marrow transplantation. Oncol Nurs Forum 20:1493–1502 McGuire DB, Yeager KA, Dudley WN, Peterson DE, Owen DC, Lin LS et al (1998) Acute oral pain and mucositis in bone marrow transplant and leukemia patients: data from a pilot study.



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