Prospective study on health-related quality of life, oral mucositis and oral health on during treatment of head and neck cancer.

BACKGROUND: Few studies have examined health related Quality of Life (HR-QoL) during the treatment of head and neck cancer (HNC) with even fewer focusing on the impact of oral mucositis (OM) on HR-QoL. Studies performed during treatment of HNC makes it possible to follow fluctuations in HR-QoL, OM and other treatment related side effects. The aim was to prospectively analyze HR-QoL, changes in clinical variables and the impact of OM on HR-QoL during HNC treatment. MATERIALS AND METHODS: Patients were recruited before commencing curative cancer treatment and were given professional oral care weekly during oncologic treatment. HR-QoL was reported before, during (week 2, 4 and 6) and three months after treatment using the EORTC Quality of Life questionnaires C30 and H&N35 and the stimulated whole salivary secretion rate was determined at the same time-points. OM (erythema and ulceration) was registered using the Oral Mucositis Assessment Scale (OMAS), at baseline, weekly during treatment and post treatment. Differences in HR-QoL between different timepoints were analyzed. To analyze the impact of OM on HR-QoL the patients were categorized into two groups: no/mild OM (OMAS ulceration score 0-1) or severe OM (OMAS ulceration score ≥ 2) and HR-QoL was compared between the two OM groups at three timepoints during treatment. RESULTS: Fifty-seven patients (43 men, 14 women), with a mean age of 58 years were included. Patients reported progressively impaired HR-QoL, with peak issues noted at weeks 4 and 6, particularly in social eating, senses, appetite loss, sticky saliva, and decreasing salivary secretion rates were determined. Patients with severe OM reported worse HR-QoL compared to those with no/mild OM. Persistent problems 3 months post treatment were appetite loss, dry mouth, senses (smell and taste) and problems with social eating. CONCLUSION: Patients experienced exacerbated symptoms and problems weeks 4 and 6 of oncological treatment, especially among those with severe OM, stressing the importance of clinically monitoring the patients to reduce and alleviate their symptoms. Persistent problems three months post treatment are likely associated with the reduced salivary secretion rate indicating that patients should be monitored also after completed oncological treatment.

Depressive symptoms and oral mucositis in children with oncological diseases: a cross-sectional study.

The aim of this study was to investigate the correlation between depressive symptoms and the occurrence of oral mucositis in children with oncological diseases treated at a reference hospital. This was a cross-sectional study conducted with individuals aged 4 to 18 years, diagnosed with primary neoplasms. Data was collected by using a questionnaire that assessed the degree of oral mucositis according to the World Health Organization index, the risk of oral mucositis according to the Child's International Mucositis Evaluation Scale, and depressive symptoms using the Children's Depression Inventory. The data were analyzed and subjected to Spearman's correlation, chi-square test, and Fisher's exact test, considering p<0.05. A statistically significant correlation was observed between depressive symptoms and the degree of oral mucositis (p = 0.044), and also between the "pain" variable within the risk of oral mucositis and depressive symptoms (p = 0.021). Based on the findings, it can be inferred that oral mucositis may be associated with the development of depressive symptoms and may be influenced by the individual's hospitalization, thereby affecting the quality of life of pediatric patients.

The broadening scope of oral mucositis and oral ulcerative mucosal toxicities of anticancer therapies.

Oral mucositis (OM) is a common, highly symptomatic complication of cancer therapy that affects patients' function, quality of life, and ability to tolerate treatment. In certain patients with cancer, OM is associated with increased mortality. Research on the management of OM is ongoing. Oral mucosal toxicities are also reported in targeted and immune checkpoint inhibitor therapies. The objective of this article is to present current knowledge about the epidemiology, pathogenesis, assessment, risk prediction, and current and developing intervention strategies for OM and other ulcerative mucosal toxicities caused by both conventional and evolving forms of cancer therapy.

Reliability and Validity of the Greek Version of the Oral Mucositis Weekly Questionnaire in the Head and Neck Cancer Context.

BACKGROUND AND PURPOSE: Oral mucositis is one of the most common treatment-induced adverse side effects in head and neck cancer patients. The purpose was to evaluate the reliability and validity of the Greek version of the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN). METHODS: The data were retrieved from 72 head and neck cancer patients who were undergoing oral radiotherapy as monotherapy or in combination with chemotherapy and surgery. Data analyses included internal consistency reliability, criterion related validity, and cross-sectional validity. RESULTS: The OMWQ-HN demonstrated good criterion validity. Strong correlations were observed between OMWQ-HN with EORTC QLQ-C30 and EORTC QLQ-H&N35 that showed good concurrent validity. The tool has a strong internal consistency index with α = .92. CONCLUSION: The Greek version of OMWQ-HN is a reliable and valid instrument that can be used for the assessment of oral mucositis in this context.

Oral health-related quality of life in oral cancer patients: systematic review and meta-analysis.

Aim: The purpose of this meta-analysis was to evaluate the impact of oral health on quality of life in oral cancer patients (OCPs). Methods: PubMed, Scopus and Web of Science databases were searched for publications on oral health-related quality of life (OHRQoL) in OCP and the information was extracted according to the PRISMA guidelines. A random effect model was used to obtain the pooled standard mean differences of Oral Health Impact Profile (OHIP)-14 questionnaire responses in meta-analysis. Results: total of 12 research papers were analyzed and revealed poor OHRQoL in OCPs (standard mean difference: 2.53; 95% CI: 1.55-3.50; p < 0.00001) compared with healthy individuals due to the effects of oncotherapy. Moreover, OHRQoL deteriorated with combinations of different treatment modalities. Conclusion: Oral health and oncotherapy can affect the quality of life in OCPs.

Can chronic oral inflammation and masticatory dysfunction contribute to cognitive impairment?

PURPOSE OF REVIEW: This article provides an overview of current literature focused on oral health and cognitive impairment in older adulthood, focusing in particular on whether oral inflammation, tooth loss and masticatory dysfunction might increase the risk of cognitive impairment in this age group. RECENT FINDINGS: There is now general acceptance that cognitive impairment contributes to poor oral health, largely through detrimental changes in behaviours related to maintaining good oral hygiene. There is more limited evidence for the reverse causal direction, but at least some studies now suggest that inflammatory mechanisms, tooth loss and masticatory dysfunction each have the potential to contribute to cognitive decline. SUMMARY: Poorer oral health significantly correlates with cognitive dysfunction, and at least some studies suggest that there may be a bi-directional causal relationship. Randomized controlled trials assessing cognitive abilities in relation to oral hygiene or oral health interventions, or provision of removable or fixed (implant-supported) dentures, are encouraged.

Changes and predictors of radiation-induced oral mucositis in patients with oral cavity cancer during active treatment.

PURPOSE: Radiation-induced oral mucositis (OM) is the most debilitating side effect of radiation treatment in oral cavity cancer. The purpose of the study was to investigate change of prevalence of severe OM, OM-related symptoms, and predictors in oral cavity cancer patients during active treatment. METHODS AND SAMPLE: Longitudinal study design with repeated measures was used. Patients with oral cavity cancer were recruited from a head and neck outpatient radiation department at a major medical center in Taiwan. Patients' OM-related symptoms were measured at three time points. Patients' oral mucosa was assessed at nine time points. Generalized estimating equations (GEE) were used to analyze the predictive factors of prevalence of severe OM and OM-related symptoms. RESULTS: Patients reported highest prevalence of severe OM at T5 (5 weeks after beginning RT) and T6 (6 weeks after beginning radiation therapy, RT), with the combined chemotherapy and RT (CCRT) patients reporting a higher prevalence than those receiving RT alone. The peak of OM-related symptoms was at T8 (8 week after beginning RT), with primary symptoms of mouth pain, mouth dryness, eating difficulties, swallowing difficulties, and taste change. Patients with CCRT, a higher cumulative radiation dose, smoking, and lower body mass index (BMI) were at high risk to develop severe OM. OM-related symptoms were predicted by type of treatment, cumulative radiation dose, and smoking. CONCLUSIONS: Patients with oral cavity cancer suffer from OM and OM-related symptoms during aggressive RT or CCRT. Patient-specific oral care and emotional support are needed to relieve distressful OM-related symptoms during active treatment.

Impact of oral mucositis on oral-health-related quality of life of patients diagnosed with cancer.

INTRODUCTION: Oral mucositis (OM) has been described as the oral complication most frequently associated with antineoplastic therapy. However, the influence on the quality of life of affected patients is still unclear. OBJECTIVE: To evaluate the impact of OM on the oral-health-related quality of life (OHRQoL) of patients diagnosed with cancer, who developed chemotherapy- and/or radiotherapy-induced OM. METHODS: This is a cross-sectional evaluation of QoL using oral health impact profile-14 (OHIP-14). The study group comprised a sample of 60 patients diagnosed with cancer, who developed OM during the treatment. The instrument (OHIP-14) composed of seven dimensions was used: functional limitation, physical pain, psychological discomfort, physical deficiency, psychological deficiency, social incapacity, and deficiency. RESULTS: The internal consistency of OHIP-14 measured by the Cronbach's α coefficient was of 0.76. Physical pain attained the highest score (worst quality of life) among the studied dimensions 60.8% (292/480), followed by physical limitation 52.7% (253/480), and psychological discomfort 50.8% (244/480). The dimension 'social limitation' obtained the lowest score 27.2% (131/480). There was statistically significant difference as regards gender (P = 0.021) for physical pain, with greater impact among patients of the male gender. CONCLUSION: Oral-health-related quality of life is significantly affected by OM in individuals diagnosed with cancer.

Parents and children's perceptions of distress related to oral mucositis during haematopoietic stem cell transplantation.

AIM: Oral mucositis is a common and debilitating side effect of haematopoietic stem cell transplantation. Our study investigated parents' and children's experiences of oral mucositis treatment and whether the parents' perceptions accurately reflected the children's views. METHODS: We analysed 71 questionnaires completed by the parents of children who had undergone haematopoietic stem cell transplantation, together with 38 questionnaires completed by children who were 7 years of age or over. RESULTS: The parent proxy and child self-reports showed good to excellent agreement. For example, 86% of the parents and 83% of the children reported oral pain and 44% of the parents and 47% of the children reported difficulty swallowing often or very often. The majority of the parents (61%) were satisfied with the pain treatment that had been given to their child. However, the treatment provided for oral mucositis was not altogether consistent. CONCLUSION: Oral mucositis affected the majority of the children undergoing haematopoietic stem cell transplantation, causing considerable pain and discomfort. The parent proxy reports proved to be reliable and are an important supplement to child self-reports on symptoms related to oral mucositis. But there is a clear need to establish more evidence-based care for children suffering from oral mucositis.

Phase III trial of low-level laser therapy to prevent oral mucositis in head and neck cancer patients treated with concurrent chemoradiation.

BACKGROUND: Oral mucositis (OM) is a complication of chemoradiotherapy treatment of head and neck squamous cell carcinoma (HNSCC) patients with no effective therapy. This study was designed to assess the efficacy of preventive low-level laser therapy (LLLT) in reducing the incidence of grade 3-4 OM. MATERIAL AND METHODS: From June 2007 to December 2010, 94 HNSCC patients entered a prospective, randomized, double-blind, placebo-controlled phase III trial. Chemoradiotherapy consisted of conventional radiotherapy plus concurrent cisplatin every 3weeks. A diode InGaAlP (660nm-100mW-1J-4J/cm(2)) was used. OM evaluation was performed by WHO and OMAS scales and quality of life by EORTC questionnaires (QLQ). RESULTS: A six-fold decrease in the incidence of grades 3-4 OM was detected in the LLLT group compared to the placebo; (6.4% versus 40.5%). LLLT impacted the incidence of grades 3-4 OM to a relative risk ratio of 0.158 (CI 95% 0.050-0.498). After treatment QLQ-C30 showed, differences favoring LLLT in physical, emotional functioning, fatigue, and pain; while the QLQ-H&N35 showed improvements in LLLT arm for pain, swallowing, and trouble with social eating. CONCLUSION: Preventive LLLT in HNSCC patients receiving chemoradiotherapy is an effective tool for reducing the incidence of grade 3-4 OM. Efficacy data were corroborated by improvements seen in quality of life.

Measuring the impact of an educational program on nurses: teaching an evidence-based approach to oral mucositis.

Oral mucositis, a cancer therapy side effect, can negatively affect quality of life. This study evaluated the effect of an educational program on nurses' knowledge and perceived need to change oral mucositis management practice. This study revealed that nurses' knowledge and perceived need to change practice were positively affected by the educational program.

Use of Rasch analysis in the evaluation of the Oropharyngeal Mucositis Quality Of Life Scale.

BACKGROUND: Oropharyngeal mucositis (OM) is a significant clinical problem causing profound impairment of health-related quality of life (HQoL) for patients undergoing cancer therapy. The Oropharyngeal Mucositis-Specific Health-Related Quality of Life Measure (OMQoL) was developed using classical test theory to measure the self-perceived HQoL of patients with mucositis. OBJECTIVES: The aim of this study was to analyze the OMQoL according to the Rasch model and, on the basis of results, determine whether improvements could be made. METHOD: A multicenter approach was used, and 210 patients treated with stomatotoxic chemotherapy (36%), high-dose myeloablative chemotherapy ± total body irradiation (10%), or head and neck irradiation ± chemotherapy (54%) completed the OMQoL. The Partial Credit Model of Rasch analysis was applied to evaluate the 31-item OMQoL using WINSTEPS and R software. Unidimensionality (measurement of a single construct), item fit, response category performance, person separation reliability, targeting of item difficulty to person ability, and differential item functioning (DIF) were examined. RESULTS: Of 31 items, 5 were removed due to misfit; the OMQoL was reduced to 26 items with acceptable information weighted fit/outlier-sensitive fit indices (within 0.7-1.3) and eigenvalue units (≤2.0), confirming the unidimensionality of the reduced OMQoL. The OMQoL and its four subscales showed ordered category thresholds, and the person separation reliability was high (person separation index >0.2 with reliability >.8). Nevertheless, some of the items in the OMQoL might not be targeted effectively to patients with low levels of OM. Significant uniform and nonuniform DIFs were not found for gender (uniform DIF, p = .26; nonuniform DIF, p= .24) and age (uniform DIF, p = .95; nonuniform DIF, p = .65). DISCUSSION: Rasch analysis reveals that the reduced 26-item OMQoL is unidimensional and is adequate to measure HQoL for patients with OM regardless of gender and age group. This improved version can provide a common platform for nurses to use in their assessment, caring, and treatment of patients with OM.

[Quality of life for patients treated for head and neck carcinoma]. / Qualité de vie chez les patients traités pour un cancer de la sphère ORL.

A large consensus admits that quality of life is a multifactorial concept including at least physical, psychical and social dimensions of the disease as well as symptoms related to the disease and to the requested treatments. Quality of life is actually considered as one of the major assessment criteria for taking care of patients with cancer and to evaluate results of clinical trials. Self-evaluation by the patient is considered as the gold standard to evaluate the clinical symptoms. This evaluation is not unambiguous. Medical doctors underestimate patients' symptoms. In the field of surgery, development of organ preservation strategies should be considered as one of the major improvement observed in the modern era of head and neck oncology. The role of xerostomia, the most frequent complication reported after head and neck radiation therapy, is major in this field. However, odynophagia is considered as the most detrimental component of quality of life. Radiation oncologists should realize the role of these parameters in order to include these concepts as relevant in the global evaluation of treatments.

The experience of a sore mouth and associated symptoms in patients with cancer receiving outpatient chemotherapy.

This study aimed to describe sore mouth (SM) severity and distress, associated symptoms, and consequences in cancer chemotherapy outpatients. Secondary analysis was used in this study. A total of 223 patients in 4 treatment centers participated in the study. Data from an intervention study using a computer-based telephone communication system to assess patients' daily symptom experience were analyzed to obtain highest, average, and lowest ratings of severity and distress for SM, fatigue, trouble sleeping, feeling down/blue, and feeling anxious. Consequence data included oral intake, time spent lying down, ability to work, and daily activity. Approximately 51% reported SM, with a mean highest, average, and lowest severity score of 3.1 in cycle 2 and 3.09 in cycle 3. Sore mouth severity was correlated with severity of fatigue, feeling down/blue, feeling anxious, and trouble sleeping. Sore mouth distress was correlated with the same symptoms. Sore mouth severity was correlated with the number of 8-oz glasses of liquid consumed, effect on daily activity, time spent lying down, but not with ability to work. Half of patients experienced SM, which was associated with several other symptoms and led to specific consequences. Understanding the complex symptom experience of patients with SM, including consequences, will assist nurses in developing more comprehensive clinical assessments and interventions. In addition, the association of multiple symptoms with SM will provide a foundation for further research investigation in oral mucositis.

Oral mucositis: a phenomenological study of pediatric patients' and their parents' perspectives and experiences.

GOAL: The purpose of this qualitative phenomenological study was to describe children's and their parents' lived experiences of oral mucositis (OM) and to explore their needs in relation to OM. MATERIALS AND METHODS: Individual semistructured interviews were conducted with 22 children who had experienced WHO grade > or = 2 OM during chemotherapy within the previous 6 months. Parents from each family were also interviewed in the same way. Interviews were audio recorded and fully transcribed verbatim. Data were analyzed using inductive content analysis. RESULTS: The mean ages of the children and parents were 12 and 41 years, respectively. Regarding gender, 55% of the children were boys, and 95% of the parents were mothers or grandmother. Forty-one percent of the children were diagnosed with acute lymphoblastic leukemia, and 36% were treated with methotrexate. The findings illustrated that the experience of OM impacted on the lives of the children and their parents. Five themes, which subsumed a number of categories, were constructed: "Symptoms experienced," "Negative emotional outcomes," "The dilemma of eating (or not eating)," "Challenges in oral care," "Health care needs." Mouth and throat pain were found to cause a number of severe consequences in daily life. Many children experienced turmoil characterized by a panoply of emotions. All parents described psychological distress on various levels which they attributed to the burden of care and the suffering of their children. OM can present a difficult dilemma to patients: on the one hand, children found it too painful to chew and swallow food, while on the other hand they felt very hungry. Children were aware of the significance of oral care. Discomfort associated with oral care forced some children to neglect oral care. Parents also described oral care as a stressful event for their children and for them. Children needed more activities coordinated by the ward to distract them from their OM, as well as psychological support from the health care professionals. Parents indicated the need for more information about the process of OM and food selection. CONCLUSION: Findings from this study illustrate the complex biopsychosocial impact of chemotherapy-induced OM on children and their parents. Optimal OM pain management guidelines and holistic supportive care strategies should be developed in conjunction with OM strategies in the future.

Application of multilevel growth-curve analysis in cancer treatment toxicities: the exemplar of oral mucositis and pain.

PURPOSE/OBJECTIVES: To introduce the use of a statistical technique known as multilevel growth-curve analysis and illustrate how the method can be advantageous in comparison with traditional repeated measures for the study of trajectories of signs and symptoms in individual patients over time. DATA SOURCES: Data were derived from use of the technique in a randomized clinical trial of a psychoeducational intervention to reduce severity of oral mucositis and oral pain. DATA SYNTHESIS: The development of new biologic models that seek to explain clustering of signs and symptoms or the appearance and resolution of signs and symptoms motivates the need to use more sophisticated statistical techniques to test such models. CONCLUSIONS: The application of multilevel growth model to an existing data set demonstrates that the model can be effective in the study of individual differences in trajectories of change in signs and symptoms. IMPLICATIONS FOR NURSING: This method for the study of changes in patients' signs and symptoms over time can be of particular interest to nursing, both from a clinical point of view and as a way to test theoretical models that have been proposed to capture patient experiences with signs and symptoms.

Patients' experiences and perceptions of chemotherapy-induced oral mucositis in a day unit.

Oral mucositis (OM) is a frequent and potentially severe complication of cancer chemotherapy. The aim of this descriptive, cross-sectional study was to better understand patients' experiences and perceptions of chemotherapy-induced OM. Fifty-seven adult patients in a chemotherapy day unit who had completed at least 2 cycles of chemotherapy within the previous 12 months and who were receiving chemotherapy at the time of study completed the questionnaire (response rate, 86.3%). Results demonstrated that 75.4% of participants (N = 57) had experienced at least one episode of OM since their first chemotherapy. Dry lips were the most common symptom of OM (n = 20, 54.1% previously; n = 14, 73.7% currently). Ulcerated mucosa was regarded as the most significant problem caused by OM (n = 14, 87.5% previously; n = 8, 100% currently), whereas pain on swallowing was considered as the most distressing mucositis-related effect (n = 14, 87.5% previously; n = 4, 100% currently). The findings revealed a high incidence of chemotherapy-induced OM. Chemotherapy-related mouth problems were perceived as problematic and caused varying degrees of distress. A systematic oral assessment method can be used in future studies with a cohort of patients to further generalize the pattern of patients' experiences of OM.

Development and validation of a Patient-Reported Oral Mucositis Symptom (PROMS) scale.

BACKGROUND AND OBJECTIVE: Oral mucositis, a painful condition with potentially life-threatening sequelae, often develops in association with allogeneic bone marrow transplantation. This condition has an adverse impact on the oral-health-related quality of life of patients undergoing marrow transplantation therapy. The purpose of this study was to create and validate a Patient-Reported Oral Mucositis Symptom (PROMS) scale. This scale allows evaluation of symptoms of oral mucositis that threaten quality of life. MATERIALS AND METHODS: The PROMS scale was compared with previously validated tools measuring quality of life (Functional Assessment of Cancer Therapy--Bone Marrow Transplant), symptoms of depression (Center for Epidemiologic Studies Depression Scale), psychological well-being (Affect Balance Scale) and stressful life events, as well as an objective, clinician-rated assessment of oral mucositis (Visual Analogue Scale--Oral Mucositis Assessment Scale). Thirty-four patients who were to undergo allogeneic bone marrow transplantation at Princess Margaret Hospital in Toronto, Ontario, were enrolled in this validation study. RESULTS: The PROMS scale had high internal reliability, as well as good convergent and discriminant validity relative to subjective measures of well-being. Longitudinal assessments showed that changes in PROMS scores were strongly correlated with changes in clinical assessment of oral mucositis over the first 2 weeks after transplantation, when the onset of oral mucositis typically occurs and the lesions are most severe. CONCLUSIONS: Oral mucositis in patients who have undergone bone marrow transplantation can be quantified reliably with the easily administered PROMS scale. The PROMSscale provides a valid measure of the impact of oral mucositis on the oral-health-related quality of life of patients affected by this malady.

Visual graphical analysis: a technique to investigate symptom trajectories over time.

BACKGROUND: Research to address clinical symptoms and the way they change over time in an individual is of paramount importance to healthcare researchers who are interested in improving the quality of life for ill patients. However, typical statistical methods that rely on means can obscure individual trajectories of change. Visual graphical analysis (VGA) is a technique that can provide researchers with an alternative method of quantitative statistical analysis that is more sensitive to individual change and variation. OBJECTIVES: To (a) describe the use of VGA as a method to evaluate longitudinal data, (b) discuss challenges to using this method, and (c) offer recommendations for future research in which the method could be implemented. APPROACH: This methodological article uses data collected from a primary study to present the method of VGA. Daily self-reported sore mouth severity scores from patients receiving outpatient chemotherapy were used in this VGA. The steps of VGA include (a) determining inclusion criteria, (b) managing missing data, (c) creating visual graphs, (d) identifying specific patterns, and (e) performing validation and verification. DISCUSSION: Because symptoms occur differently for each patient, this method allows researchers to see symptom trajectories on an individual basis. Creation and analysis of longitudinal graphs could be used also to inspect other symptoms or clinical problems such as headaches, fatigue, constipation, nausea and vomiting, and psychological difficulties. The value of VGA is that it allows a researcher to study the patterns of an individual's experience, as opposed to averaging all individuals' responses over time. Although graphical analysis is exploratory in nature, it may lead to enhanced longitudinal recognition of symptoms that might not be identified otherwise by quantitative data analysis using summary statistics.