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«The Experience of a Sore Mouth and Associated Symptoms in Patients With Cancer Receiving Outpatient Chemotherapy By: Brown, Carlton G. PhD, RN, AOCN; ...»

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Specific aim 3 explored the consequences of the overall experience of SM and other symptoms in outpatients receiving chemotherapy. Table 4 presents descriptive data from patients with and without an SM in relation to amount of daily oral intake daily activity and time spent lying down. To investigate the presumed consequences of an SM, articulated earlier in the discussion of the conceptual model, associations between HAL SM severity scores and HAL scores of amount of daily oral liquid intake, daily activity, and time spent lying down were investigated using bivariate Pearson correlations. There was a significant positive correlation between SM severity and the number of 8-oz glasses of liquid consumed (r223 = 0.85 [large effect size], P =.001) and between SM severity and interference with daily activity (r223 = 0.31 [medium effect size], P.001). As SM severity increased, it seemed that symptoms prevented participants from completing daily activities. There was also a significant positive correlation between SM severity and time spent lying down (r223 = 0.39 [medium effect size], P =.001). Thus, as SM severity increased, so did a participant's time spent lying down. Finally, for the 57 participants who were actively working, there was no significant correlation between SM severity and percentage of days they worked when they were supposed to have worked, r57 = -0.12, P =.39 (Table 5).

Table 4 Consequences in Participants With and Without Sore Mouth

Table 5 Correlations of Sore Mouth (SM) Severity and ConsequencesDiscussion

The purpose of this study was to describe the experience of SM, with a focus on severity and distress, associated symptoms, and consequences in patients with cancer receiving cycles 2 and 3 of outpatient chemotherapy. The finding in specific aim 1 suggested that approximately half of the patients experienced an SM, which is somewhat higher than that reported by Dodd et al 1 of an incidence rate between 23% and 26%.

Patients in the study by Dodd et al 1 who received similar chemotherapy agents (doxorubicin, 5-fluorouracil, paclitaxel, methotrexate) also received an oral care program entitled PRO-SELF, which might have been partially responsible for the lower levels of mucositis in similar patients in addition to factors discussed earlier.

Patients in the secondary analysis study reported here did not receive a formal oral care program, nor was prospective evaluation of OM using the OAG or any other tool possible.

In addition, this study's finding of a HAL SM score of approximately 3 on a 0 to 10 scale is new and suggests SM in this sample may not be very severe. Participants with an SM were more likely to have breast cancer and non-Hodgkin lymphoma and to receive chemotherapy treatments of doxorubicin and cyclophosphamide (AC) and rituximab plus cyclophosphamide, oncovin, doxorubicin, and prednisone (R-CHOP). This finding is not surprising given that anthracycline-based regimens such as AC have been associated with higher levels of OM incidence.24 In this study, women (79.5%) were more likely to report an SM when compared with men. This is similar to work conducted by Vokurka and colleagues,26 who reported a higher incidence of chemotherapyinduced OM in female patients.

The finding in specific aim 2 indicating that both SM severity and distress were positively associated with fatigue, trouble sleeping, feeling down/blue, and feeling anxious is interesting. Because the correlations were moderate, it is unclear precisely how these variables are influencing one another. Nevertheless, this information is important because it suggests that having an SM over a period of time may contribute to trouble sleeping and fatigue, which may in turn lead to feeling down/blue and feeling anxious. These findings support clinical observations that patients with OM often report fatigue, trouble sleeping, depression, and anxiety. In addition, the results are supported by, and add to, previous studies demonstrating relationships among pain, anxiety, depression, and insomnia.16,20 Of interest, in the cases of trouble sleeping, feeling down/blue, feeling anxious, and fatigue, the mean HAL scores are higher for distress than they are for severity of a symptom (see Table 2).

This finding suggests that patients rate the distress of a particular symptom, such as fatigue for instance, higher (more troublesome) than they do the severity of the same symptom.

One of the most intriguing elements of these results is the potential insight they may provide into fundamental biological mechanisms underlying interrelated symptoms. There are increased levels of proinflammatory cytokines (especially tumor necrosis factor and interleukin-6) in patients with nonhematologic toxicities that include mucositis.42 Some researchers have theorized that symptom clusters occur as a direct result of massive proinflammatory cytokine production.43 A massive release of cytokines during the ulcerative phase of OM might explain, in part, why patients with OM also experience other symptoms such as fatigue and depression.24 There is recent evidence implicating proinflammatory cytokines as a potential factor in the etiology of anorexia, cachexia, anemia, pain, sleep disturbance, fatigue, and depression.44 Thus, increased release of proinflammatory cytokines occurring as a result of OM may likely contribute to sleep disturbance, fatigue, depression, and anxiety.24 Although exploring this hypothesis is beyond the scope of this study, the relationships found in this secondary analysis provide a foundation for prospective examination of relationships among symptoms, particularly if researchers are able to conduct a prospective study with precise measures of OM. One potentially fruitful area for investigation might involve the identification of symptom clusters involving OM, fatigue, sleep disturbances, depression, and anxiety, coupled with an exploration of possible etiological mechanisms.18 The finding in specific aim 3 that, as participants experienced increased SM severity, they had decreased daily activities and increased time spent lying down is new but not surprising. What was surprising was that oral intake increased as the severity of participants' SM increased. Clinically, this is counterintuitive since patients often experience an SM that is painful enough to prevent oral intake of both food and liquids. However, because data were collected from the second and third cycles of chemotherapy, it is possible that patients' experiences of SM in cycle 1 taught them that they could tolerate oral intake despite discomfort. In addition, they may have received education from their healthcare providers on the importance of proper oral intake after chemotherapy.

Perhaps the most likely explanation is that because of the HAL severity score of approximately 3 (in a range of 1-10), overall SM severity was not significant enough to interfere significantly with oral intake.

The finding that an increase in SM did not significantly affect patients' ability to work suggests that, although they had negative consequences as a result of SM and other symptoms, those consequences did not interfere with their work role. This finding is limited, however, by the fact that only 57 participants were working while receiving outpatient chemotherapy.

Previous research focusing on the consequences of OM has been limited, as noted earlier, with existing research focusing on economic, clinical, and quality of life outcomes using aggregated samples across a variety of disease and treatment types.13,45 Although this work is important, it does not focus on the actual daily consequences related to OM nor to SM. Thus, the unique aspect of this study is that it lays a foundation for future prospective investigation (using precise OM measurement tools) of the impact of OM on important elements of daily life such as nutrition and functional status.


Conduct of a secondary analysis study poses certain limitations that must be noted. First, the data analysis is restricted to the data already collected, and these data may not provide all the needed information. For instance, in this study, SM was used as a subjective indicator for OM, thus it is unclear whether the 115 patients reporting SM actually had documented OM, which by definition consists of erythema and ulceration and may or may not include oral pain (SM).24 As a result, the associations among severity and distress of SM (and therefore presumed OM) and other symptoms must be cautiously interpreted. Second, the items used in this secondary analysis were single indicator items assumed to represent the constructs of fatigue, insomnia, depression, and anxiety as opposed to psychometrically sound scales measuring these constructs, thus it cannot be assumed that the single items were valid measures of the constructs of interest.

Several factors prevent generalizing these findings beyond the immediate sample. First, the sample consisted primarily of white women with some college education, who were married and had breast cancer. Second, data were analyzed only for cycles 2 and 3 of chemotherapy. Details of SM and the relationships with other symptoms during the first cycle of chemotherapy (received prior to participating in the TLC study [Table 6]) and all subsequent cycles were not available. Finally, the parent study also investigated nausea and vomiting, distress about changes in appearance, fever and chills, diarrhea, constipation, and pain other than SM, but relationships among SM and these symptoms were not examined as they were beyond the scope of this inquiry.

Thus, the possibility that significant relationships may have existed among SM and other symptoms cannot be ruled out.

Table 6 Telephone-Linked Care Script of Questions Asked of Participants Although the HAL method helped capture the variability in individual ratings of symptoms, the researchers acknowledge that there are limitations to this method. The HAL technique and other traditional statistical methods (eg, repeated-measures analysis of variance) are useful when studying mean group differences in change over time,46 but these same methods limit the ability to explore individual symptom trajectories over time. A different technique, known as visual graphical analysis, described recently by several of this manuscript's authors,47 offers a method for investigating individual daily patterns of symptoms over time and might be useful in future prospective work.

Implications and Conclusions

Clinical implications of these results include both assessment and management. As long as outpatients experience OM and associated symptoms as a consequence of chemotherapy, there is a clear need for a better system to assess symptoms. This can be a challenge because these patients are not usually followed in person between cycles of chemotherapy. These assessments should use validated instruments that include visual analog or numerical rating scales 17 to obtain self-reported symptom data if at all possible. Another important implication is identifying better methods to obtain data on OM rather than the subjective indicator of SM in these patients. Teaching patients how to use standard tools for assessing oral complications, such as the OAG,31 is one possible strategy, although the OAG has limitations as a precise measure of OM. Additional work should focus on developing ways to more specifically assess presence, severity, and consequences of OM in chemotherapy outpatients. It is important that an assessment should focus on patients with particular risk factors and in different age cohorts.48 The association of symptoms with SM and the consequences observed in patients with OM suggest that interventions targeting these symptoms and their sequelae warrant investigation. To date, there have only been a few attempts to develop interventions that target OM and some of its associated symptoms.21 Development of therapeutic interventions that may eliminate or ameliorate SM and related symptoms could focus not only on symptom management but also on improving patients' abilities to reduce negative consequences and improve their functional status and overall quality of life.

There are important educational implications arising from this study. Healthcare providers should be educated on the importance of assessing multiple symptoms in outpatients to alleviate those symptoms, to improve quality of life, and to provide patients with the best opportunity to complete their respective treatment and to cure or control their cancer. Furthermore, appropriate education of healthcare providers should include the important consideration of the consequences and detriments to daily living, such as oral intake and time spent lying down, of SM and associated symptoms. In addition, patients could be educated on ways to eliminate or lessen some of the consequences associated with chemotherapy treatment. For example, education on the importance of proper oral intake of fluids during the treatment regimen is vital to lessen the chances of dehydration.

Research implications of these results are numerous. It is important to conduct prospective longitudinal studies that measure actual OM to identify symptoms associated with OM and to determine whether they include pain, sleep disturbance, fatigue, depression, anxiety, and other symptoms. Learning more about the nature and trajectory of symptom associations throughout treatment and interrelationships of symptoms within clusters over time should be helpful in assessment and management.

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