Validation of the Children's International Mucositis Evaluation Scale (ChIMES)

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DESCRIPTION (provided by applicant): Validation of the Children's International Mucositis Evaluation Scale (ChIMES) Sung, Lillian Preamble: Oral mucositis is one of the most distressing side effects of treatment for children with cancer receiving chemotherapy and stem cell transplantation (SCT). In order to determine the most effective prevention and treatment strategies, we need feasible, psychometrically sound and clinically useful outcome measures of oral mucositis. Our group has developed a program of research in developing a pediatric specific oral mucositis measure and in this grant proposal, we plan to extend our previous research by evaluating the psychometric properties of the Children's International Mucositis Evaluation Scale (ChIMES). Specific Aims: Aim 1 a) To evaluate test-retest reliability by demonstrating an intraclass correlation coefficient (ICC) e 0.7 when the total ChIMES scores are examined on days 13 and 14 for those who report no change in mucositis; b) To evaluate inter-rater reliability by demonstrating an ICC e 0.5 when the total ChIMES scores are compared between parents and children e 12 years of age on day 14; and c) To evaluate internal consistency by expecting Cronbach's alpha e 0.7. Aim 2 a) To evaluate discriminant validity by anticipating total ChIMES scores will be higher with SCT compared to chemotherapy; b) To evaluate convergent validity by anticipating total ChIMES score will be moderately correlated with other measures of mucositis namely visual analogue scale (VAS), National Cancer Institute Common Toxicity Criteria (NCI-CTC), World Health Organization scale (WHO) and Oral Mucositis Daily Question (OMDQ) by anticipating a Spearman correlation e 0.35; and c) To evaluate responsiveness by demonstrating a significant increase in total ChIMES score from baseline to day 14 in children who report oral mucositis on day 14. Methods: This is a multi-center prospective study that will enroll patients in 5 centers in the United States, Canada and the United Kingdom. We will include children 0 to 18 years of age receiving chemotherapy associated with a higher risk of mucositis and those receiving any SCT. We will measure mucositis using ChIMES at baseline and daily from days 7 to 17 following initiation of chemotherapy or conditioning for SCT. Other measures of mucositis will be VAS, NCI-CTC, WHO and OMDQ. For older children (12 years and older), the children will be the respondent while for younger children (less than 12 years), the parent will be the respondent. We intend to enroll 200 subjects over 2 years, which will be sufficient to meet the study aims. Significance: Oral mucositis is one of the most debilitating side effects of chemotherapy. In order to assess whether interventions have a meaningful impact and to facilitate clinical care, feasible, psychometrically sound and clinically useful outcome measures are required. This program of research, to develop such an outcome measure for oral mucositis, is critically important to improve quality of life during treatment for children with cancer who receive chemotherapy and SCT. PUBLIC HEALTH RELEVANCE: Validation of the Children's International Mucositis Evaluation Scale (ChIMES) Sung, Lillian Mouth sores are one of the most distressing and painful side effects of chemotherapy and stem cell transplantation. In order to study treatments to prevent or treat them, we need good instruments to measure mucositis suitable for children and thus, we have developed the Children's International Mucositis Evaluation Scale (ChIMES). This grant proposal is designed to determine whether this instrument is good at measuring the effects of mucositis and thus, our study is critically important in order to study ways to reduce or prevent mouth sores and improve quality of life for children with cancer.