Healthcare professional perspectives following implementation of an infection management care pathway for pediatric patients with cancer: a qualitative study.

PURPOSE: The Pediatric Oncology Group of Ontario (POGO) supported an effort to implement infection management care pathways based on clinical practice guidelines, to improve the consistency of infection management in pediatric cancer patients. The objective of this qualitative study was to describe the perspective of healthcare professionals (HCPs) following implementation. METHODS: Four tertiary pediatric oncology centers in Ontario, Canada, implemented the pathways. We randomly identified three HCPs per group (clinical pharmacists; nurse case managers, educators or practitioners and physician assistants; pediatric oncology fellows; or pediatric oncology staff physicians) per site and invited them to participate in a qualitative interview. One-on-one interviews were conducted remotely, followed by thematic analysis of interview transcripts. RESULTS: A total of 66 invitations were extended and 42 HCPs participated. Identified themes were: (1) implementation approach, (2) access and navigation, (3) engagement, (4) concerns, (5) workplace benefits, (6) reception, and (7) provincial harmonization. HCPs preferred in-person implementation strategies over e-mail communication. They identified teaching/educational utility and benefits to non-oncology departments and non-tertiary centers participating in shared care of patients. Other positive aspects related to evidence-based practice, safety, supporting oncology HCPs, and benefits to patients and families. Concerns included need to ensure users applied clinical judgement and loss of autonomy. Provincial harmonization of practice was viewed positively, although potential logistical and institutional cultural barriers were raised. CONCLUSIONS: Following infection management care pathway implementation, HCPs described educational utility and benefits to non-oncology departments, oncology HCPs, patients, and families. Our findings may facilitate future infection management care pathway provincial harmonization.

Reliability and validity of proxy-SSPedi and mini-SSPedi in pediatric patients 2-7 years receiving cancer treatments.

BACKGROUND: Symptom Screening in Pediatrics Tool (SSPedi) was developed for symptom screening by children 8-18 years. Objectives were to evaluate the reliability and validity of proxy-SSPedi and self-report mini-SSPedi for younger children. METHODS: This multi-center study enrolled guardians of children 2-7 years receiving cancer treatments (proxy-SSPedi) and their children 4-7 years (mini-SSPedi). The two populations were: (1) More symptomatic group where children were receiving active cancer treatment and were in hospital or clinic for four consecutive days; and (2) Less symptomatic group where children were receiving maintenance therapy for acute lymphoblastic leukemia or had completed cancer therapy. Proxy-SSPedi or mini-SSPedi were completed with measures of mucositis, nausea, pain, quality of life and overall symptoms. Respondents in the more symptomatic group repeated proxy-SSPedi/mini-SSPedi and a global symptom change scale 3 days later. RESULTS: There were 402 guardians and 326 children included in the analysis. Test re-test reliability of proxy-SSPedi showed intraclass correlation coefficient (ICC) 0.83 (95% confidence interval (CI) 0.72-0.90). Mean difference in proxy-SSPedi between more and less symptomatic groups was 9.7 (95% CI 8.3-11.1). Proxy-SSPedi was responsive to change and hypothesized relationships between measures were observed. With a priori threshold ≥0.6, inter-rater ICC among all dyads and those 6-7 years were 0.54 (95% CI 0.45-0.62) and 0.62 (95% CI 0.50-0.71) respectively. Among participating children, other hypothesized reliability and validity thresholds were generally met. CONCLUSIONS: Proxy-SSPedi is reliable, valid and responsive in children 2-7 years old receiving cancer treatments. Mini-SSPedi can be used for children 6-7 years of age.

Creating and adapting an infection management care pathway in pediatric oncology.

PURPOSE: While care pathways based upon clinical practice guidelines (CPGs) are important, little is known about optimal approaches to development and adaptation in pediatric oncology. Objectives were to develop care pathway templates for pediatric cancer supportive care that are based upon CPGs and to adapt an infection management care pathway for use at a single institution. METHODS: Study phases were as follows: (1) creation of care pathway templates across multiple supportive care topics; (2) refinement of the infection management care pathway template by interviewing pediatric oncology clinicians at a single institution; and (3) adaptation of the infection management care pathway template for use at a different institution. RESULTS: Informed by seven CPGs, an initial iteration of the infection management care pathway template was created. This template was then refined based upon 20 interviews with pediatric oncology clinicians. Adaptation of the infection management care pathway template for use at a different institution required many changes to improve its clinical usability. Specificity and additional information not considered by the source CPGs were incorporated. CONCLUSION: We developed a process to create care pathway templates across multiple supportive care topics in pediatric oncology and to refine and adapt the infection management care pathway. While we found that the process was feasible, we also identified the need to substantially modify the care pathway during the adaptation process to consider scenarios not addressed by the source CPGs. Future work should measure implementation success.

Reasons for disagreement between proxy-report and self-report rating of symptoms in children receiving cancer therapies.

PURPOSE: To qualitatively describe reasons for disagreement in ratings of bothersome symptoms between child self-report and parent proxy-report. METHODS: We enrolled child and parent dyads, who understood English and where children (4-18 years of age) were diagnosed with cancer or were hematopoietic stem cell transplantation (HSCT) recipients. Each child and parent separately reported symptoms using self-report or proxy-report Symptom Screening in Pediatrics Tool (SSPedi). We then used semi-structured interviews to elicit reasons for discrepancies in symptom reporting. RESULTS: We enrolled 12 dyads in each of four age cohorts, resulting in 48 dyads. Forty-one dyads (85.4%) had disagreement in rating the presence or absence of at least one symptom. Themes identified as reasons for disagreement included (1) perception, differing perception of symptom or availability or palatability of intervention; (2) understanding, difficulty orienting to time frame or concept of bother; (3) lack of communication, including child not acknowledging or talking about experiences; (4) projection, of how the parent felt or how they assumed the child would feel; and (5) discrepancy, in how the amount of symptom bother that was initially reported on SSPedi, by either child or parent, did not align with what was reported during the dyad discussion. CONCLUSION: We identified themes that explained disagreement in ratings of bothersome symptoms between child self-report and parent proxy-report. Some disagreement may be reduced by enhancing communication about symptom reporting between child and parent. Future research should focus on methods of symptom screening that encourage communication between children with cancer and their caregivers.

Identifying clinical practice guidelines for symptom control in pediatric oncology.

BACKGROUND: Children with cancer commonly experience distressing symptoms such as pain, fatigue and nausea. Improvements in patient outcomes have been associated with implementation of clinical practice guideline-consistent care across several domains. The objective of this study was to develop a process to identify symptom management clinical practice guidelines (CPGs) applicable to children and adolescents receiving cancer treatments. METHODS: We focused on identifying CPGs to manage 15 symptoms. The process defined three Tiers of CPGs based upon applicability to pediatric cancer patients and ease of identification: Tier 1: endorsed by the Children's Oncology Group; Tier 2: housed in the Emergency Care Research Institute repository, or developed by the American Society of Clinical Oncology or National Institute for Health and Care Excellence; and Tier 3: identified by systematic review. We first searched for CPGs published 2015-2020 and identified Tiers 1 or 2 CPGs. If unavailable or scope was too narrow, we proceeded to Tier 3. If CPGs were not identified, we repeated these steps for CPGs published 2010-2014. RESULTS: There were six Tier 1 and 13 Tier 2 CPGs published 2015-2020 across the 15 symptoms. Four symptoms required progression to Tier 3 because CPGs were absent (anger) or because scope was too narrow (pain, anorexia/excessive hunger and diarrhea). The systematic review identified three CPGs for pain and none for the other three symptoms. In total, CPGs were identified for 14 of 15 symptoms. None were identified for anger. CONCLUSION: We created a process to identify supportive care CPGs for pediatric cancer symptom management and were able to identify CPGs that addressed 14 of 15 symptoms. Future work should focus on evaluating implementation techniques for these CPGs and determining the impact of these CPGs on provider and patient outcomes.

Feeling scared or worried self-report in children receiving cancer treatments using the Symptom Screening in Pediatrics Tool (SSPedi).

INTRODUCTION: The objectives of this study were to describe reports of bother for feeling scared or worried among children with cancer and pediatric hematopoietic stem cell transplant (HSCT) recipients, and to identify factors associated with it. METHODS: We included children receiving cancer treatments who were 8-18 years of age. Three patient types were enrolled: inpatients receiving active cancer treatment, outpatients receiving maintenance acute lymphoblastic leukemia chemotherapy, and outpatients in survivorship. Amount of bother due to feeling scared or worried yesterday or today was self-reported using the Symptom Screening in Pediatrics Tool (SSPedi) on a 0-4 scale. Risk factors were evaluated using logistic regression. RESULTS: Among the 502 children included, 225 (45.0%) reported any degree of bother (score ≥ 1) and 29 (5.8%) reported severe bother (score ≥ 3) for feeling scared or worried. In multiple regression evaluating any bother, boys were less likely to be bothered (odds ratio (OR) 0.60, 95% confidence interval (CI) 0.41-0.87) and inpatients receiving active cancer treatment were more likely to be bothered compared to outpatients in survivorship (OR 3.58, 95% CI 2.00-6.52). The only factor associated with being severely bothered by feeling scared or worried was clinic visit or admission due to fever (OR 4.57, 95% CI 1.24-13.60). DISCUSSION: We found 45% of children receiving cancer treatments reported being bothered by feeling scared or worried. Girls and inpatients receiving active treatment experienced more bother of any degree, while visiting the hospital due to fever was associated with being severely bothered. Future work should identify interventions to prevent or alleviate this symptom.

Changes in hunger among pediatric patients with cancer and hematopoietic stem cell transplantation recipients.

PURPOSE: Change in hunger is a common and bothersome symptom among pediatric patients receiving cancer treatments. Objectives were to describe how children and adolescents receiving cancer treatments experience changes in hunger, factors associated with both increases and decreases in hunger, and coping strategies used by these patients. METHODS: We enrolled children and adolescents 4-18 years of age with cancer or hematopoietic stem cell transplantation (HSCT) recipients who were actively receiving treatment or who had completed therapy. Using a single, qualitative, semi-structured interview, we asked participants about the experience of increases or decreases in hunger, including characteristics of the change and identified coping strategies. RESULTS: There were 50 children enrolled; 25 (50%) were 4-10 years of age and 33 (66%) were boys. Most often, patients associated an increase in hunger with corticosteroid administration, while other treatments, accompanying symptoms, inactivity, and the hospital environment were associated with a decrease in hunger. Many reported that no coping strategies were successful. For those who did report successful strategies to manage an increase in hunger, these included sleep and having food available. Strategies used to manage a decrease in hunger included anti-emetic medications, increased caloric intake, varied food choices, encouragement to eat, scheduling or tracking of meals, and physical activity. CONCLUSIONS: Both increases and decreases in hunger were commonly described. Some coping strategies were reported to be successful. Further research should identify and test interventions to manage changes in hunger in pediatric cancer patients.

Development of mini-SSPedi for children 4-7 years of age receiving cancer treatments.

BACKGROUND: The Symptom Screening in Pediatrics Tool (SSPedi) is valid for assessing symptoms in children aged 8-18 years receiving cancer treatments. The objective was to develop a new self-report symptom screening tool for children receiving cancer treatments who are 4-7 years of age (mini-SSPedi), based on SSPedi. METHODS: Respondents were children with cancer or pediatric hematopoietic stem cell transplantation (HSCT) recipients who were 4-7 years of age. We included the same 15 symptoms contained in SSPedi. Using cognitive interviewing, we developed mini-SSPedi in three phases and made decisions based upon respondent understanding. First, we developed questionnaire structure regarding recall period, concept of bother and response option format. Second, we determined wording of each symptom. Third, we evaluated the entire mini-SSPedi instrument for understanding and ease of completion. RESULTS: We enrolled 100 participants in total and included 30, 40 and 30 in each of the three phases. Questionnaire structure was satisfactory with a recall period of "today" and a faces-based 3-point Likert scale. Bother was well-understood. Five symptoms required modification to achieve satisfactory understanding while the remaining 10 SSPedi symptoms did not require modification. Among the last 10 children enrolled, all understood each mini-SSPedi item and none thought mini-SSPedi was hard to complete. CONCLUSION: We developed a symptom screening tool for children with cancer and pediatric HSCT recipients between 4 and 7 years of age that is understandable and easy to complete. Future work will evaluate the psychometric properties of mini-SSPedi and develop an electronic version of the instrument.

Optimizing symptom control in children and adolescents with cancer.

There is growing recognition of the degree to which symptoms negatively impact on children receiving cancer treatments. A recent study described that almost all inpatient pediatric oncology patients are experiencing at least one bothersome symptom and almost 60% are experiencing at least one severely bothersome symptom. Poor symptom control occurs because of challenges with communication of bothersome symptoms to clinicians, lack of clinical practice guidelines (CPGs) for most of these symptoms, and failure to administer preventative and therapeutic interventions known to be effective for symptom control. This article reviews approaches used to improve symptom control for children receiving cancer treatments. Areas addressed include systematic symptom screening and creation of CPGs for symptom management. Challenges with electronic health integration are also addressed. Several multi-symptom assessment scales have been developed but none have yet been used to directly influence patient management. The number of CPGs applicable to symptom control in pediatric oncology is increasing but remains small. Improving the creation of and adherence to CPGs for symptom management is an important priority. Finally, identifying ways that symptom management systems can be integrated into clinical work flows is essential; these will likely need to focus on electronic health records.

Taste changes in children with cancer and hematopoietic stem cell transplant recipients.

BACKGROUND: Objectives were to describe bothersome self-reported changes in taste in pediatric oncology and hematopoietic stem cell (HSCT) patients and to identify patient and treatment-related factors associated with bothersome taste changes. METHODS: We prospectively enrolled children and adolescents with cancer or pediatric HSCT recipients 8-18 years of age from three groups: inpatients receiving cancer treatments; outpatients in maintenance therapy for acute lymphoblastic leukemia (ALL); and outpatients in survivorship. Bothersome changes in taste was self-reported using the Symptom Screening in Pediatrics Tool (SSPedi); nausea was self-reported using the Pediatric Nausea Assessment Tool (PeNAT). RESULTS: Among the 502 children included, 226 (45.0%) reported bothersome taste changes and 48 (9.6%) reported severely bothersome taste changes. In multiple regression, factors independently associated with severely bothersome taste changes were: inpatients receiving cancer treatments vs outpatients in survivorship (odds ratio (OR) 12.28, 95% confidence interval (CI) 2.50-222.27), ALL in maintenance vs outpatients in survivorship (OR 7.43, 95% CI 1.06-147.77), current nausea (OR 1.59, 95% CI 1.04-2.42), vomiting (OR 2.18, 95% CI 1.06-4.38), and first language not English (OR 2.09, 95% CI 0.97-4.28). CONCLUSIONS: We found that 45% of children with cancer and pediatric HSCT recipients reported bothersome changes in taste and these were severely bothersome in 9.6% of children. Inpatients receiving cancer treatment, those experiencing more nausea and vomiting and children whose first language was not English were at greater risk of severely bothersome changes in taste. Future work should evaluate systematic symptom screening in clinical practice and identify interventions focused on addressing bothersome taste changes.

Severely bothersome fatigue in children and adolescents with cancer and hematopoietic stem cell transplant recipients.

BACKGROUND: Objectives were to describe bothersome fatigue in children with cancer and hematopoietic stem cell (HSCT) recipients and to identify factors associated with severely bothersome fatigue. METHODS: We included children ages 8-18 years treated for cancer or HSCT recipients from three groups: [1] receiving active cancer treatment and admitted to hospital for at least 3 days, [2] attending outpatient clinic for acute lymphoblastic leukemia maintenance therapy, and [3] attending outpatient clinic following treatment completion. Fatigue was measured using the Symptom Screening in Pediatrics Tool (SSPedi); severely bothersome fatigue was defined as a lot or extremely bothersome fatigue (score of 3-4 on 0-4 scale). Factors associated with severely bothersome fatigue were examined using univariate and multiple logistic regression. RESULTS: Of 502 children included, 414 (82.5%) reported some degree of bothersome fatigue (scores 1-4), and 123 (24.5%) reported severely bothersome fatigue (score 3 or 4). In multiple regression analysis, factors significantly associated with severely bothersome fatigue were child age 11-14 and 15-18 years vs 8-10 years (odds ratio (OR) 2.11, 95% confidence interval (CI) 1.21-3.77 and OR 2.96, 95% CI 1.66-5.44), and inpatients receiving cancer treatment vs outpatients who had completed therapy (OR 3.85, 95% CI 2.17-7.27). CONCLUSIONS: We found that 82.5% of children with cancer or HSCT recipients reported bothersome fatigue and 24.5% of children reported severely bothersome fatigue. Risk factors for severely bothersome fatigue were older age and inpatients receiving active cancer treatment. Future work should evaluate systematic symptom screening in clinical practice and apply interventions to reduce fatigue.

Changes in taste among pediatric patients with cancer and hematopoietic stem cell transplantation recipients.

PURPOSE: Changes in taste is a common bothersome symptom in children receiving cancer treatments. However, little is known about how pediatric cancer patients experience this symptom. The objective was to describe how children receiving cancer treatments experience taste alterations and the approaches they use to address the issue. METHODS: In this qualitative study, we included English-speaking children 4-18 years of age with cancer or hematopoietic stem cell transplantation recipients who were actively receiving cancer treatment or who had completed therapy. Using a semi-structured questionnaire, we asked questions about the experience of altered taste sensation. We asked about its characteristics, impacts and identified coping strategies. RESULTS: We included 50 children. Children experienced changes in taste in a heterogeneous fashion although commonly described food as tasting "different", "not right" or "funny". While change in food preferences due to taste alterations was common, specific choices varied. Many found changes started with treatment initiation or mid-way through treatment, and some found that symptoms persisted up to 9 months following treatment completion. Actions taken to address taste changes were sucking on candy, brushing teeth and modifying food choices. CONCLUSIONS: The experience of changes in taste was common yet highly variable in its presentation and resultant changes in food preferences. Taste changes did not always resolve soon after treatment completion. Future research should identify ways to manage this symptom in pediatric cancer patients.

Child and adolescent self-report symptom measurement in pediatric oncology research: a systematic literature review.

OBJECTIVE: Previous work in pediatric oncology has found that clinicians and parents tend to under-report the frequency and severity of treatment-related symptoms compared to child self-report. As such, there is a need to identify high-quality self-report instruments to be used in pediatric oncology research studies. This study's objective was to conduct a systematic literature review of existing English language instruments used to measure self-reported symptoms in children and adolescents undergoing cancer treatment. METHODS: A comprehensive literature search was conducted in MEDLINE/PubMed, EMBASE, CINAHL, and PsycINFO to identify relevant articles published through November 10, 2016. Using pre-specified inclusion/exclusion criteria, six trained reviewers carefully screened abstracts and full-text articles for eligibility. RESULTS: There were 7738 non-duplicate articles identified in the literature search. Forty articles met our eligibility criteria, and within these articles, there were 38 self-report English symptom instruments. Most studies evaluated only cross-sectional psychometric properties, such as reliability or validity. Ten studies assessed an instrument's responsiveness or ability to detect changes in symptoms over time. Eight instruments met our criteria for use in future longitudinal pediatric oncology studies. CONCLUSIONS: This systematic review aids pediatric oncology researchers in identifying and selecting appropriate symptom measures with strong psychometric evidence for their studies. Enhancing the child's voice in pediatric oncology research studies allows us to better understand the impact of cancer and its treatment on the lives of children.

Eliciting the child's voice in adverse event reporting in oncology trials: Cognitive interview findings from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events initiative.

BACKGROUND: Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. PROCEDURE: From seven pediatric research hospitals, children/adolescents ages 7-15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive interviews with retrospective probing were completed with children in the age groups of 7-8, 9-12, and 13-15 years. The children/adolescents and proxies were interviewed independently. RESULTS: Two rounds of interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as "very easy" or "somewhat easy" and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. CONCLUSIONS: The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.

Instruments to measure anxiety in children, adolescents, and young adults with cancer: a systematic review.

PURPOSE: The primary objective was to describe anxiety measurement instruments used in children and adolescents with cancer or undergoing hematopoietic stem cell transplantation (HSCT) and summarize their content and psychometric properties. METHODS: We conducted searches of MEDLINE, Embase, PsycINFO, HAPI, and CINAHL. We included studies that used at least one instrument to measure anxiety quantitatively in children or adolescents with cancer or undergoing HSCT. Two authors independently identified studies and abstracted study demographics and instrument characteristics. RESULTS: Twenty-seven instruments, 14 multi-item and 13 single-item, were used between 78 studies. The most commonly used instrument was the State-Trait Anxiety Inventory in 46 studies. Three multi-item instruments (Children's Manifest Anxiety Scale-Mandarin version, PROMIS Pediatric Anxiety Short Form, and the State-Trait Anxiety Inventory) and two single-item instruments (Faces Pain Scale-Revised and 10-cm Visual Analogue Scale, both adapted for anxiety) were found to be reliable and valid in children with cancer. CONCLUSIONS: We identified 14 different multi-item and 13 different single-item anxiety measurement instruments that have been used in pediatric cancer or HSCT. Only three multi-item and two single-item instruments were identified as being reliable and valid among pediatric cancer or HSCT patients and would therefore be appropriate to measure anxiety in this population.

Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events.

BACKGROUND: Symptoms arising from disease or treatment are subjective experiences. Insight into pediatric oncology treatment side effects or symptoms is ideally obtained from direct inquiry to the ill child. A concept-elicitation phase in a patient-reported outcome (PRO) instrument design provides an opportunity to elicit children's voices to shape cancer symptom selection and terminology. METHODS: Through semistructured, one-on-one, voice-recorded interviews, symptom data were collected from 96 children with cancer between the ages of 7 and 20 years who were undergoing oncologic treatment at 7 pediatric oncology sites in the United States and Canada. RESULTS: The mean number of symptoms reported per child over the prior 7 days was 1.49 (range, 0-7; median, 1; standard deviation, 1.56). The most common symptoms across all age groups were tiredness or fatigue, nausea or vomiting, aches or pains, and weakness. There was not a statistically significant correlation between self-reported wellness and the number of reported symptoms (r = -0.156, n = 65, P = .215) or the number of symptoms reported by age group or diagnosis type. Forty participants reported experiencing a change in their body in the past week, with one-third of these changes unanticipated. Only through direct questions about feelings were emotional symptoms revealed because 90.6% of interviewees who discussed feelings (48 of 53) did so only in the context of direct questioning on feelings. Adolescents were more likely than younger children to discuss feelings as part of the interview. CONCLUSIONS: Concept elicitation from children and adolescents has the potential to enable researchers to develop age-appropriate, accurately representative PRO measures.

A pilot study to evaluate the feasibility of individualized yoga for inpatient children receiving intensive chemotherapy.

BACKGROUND: Fatigue is an important problem in paediatric cancer patients and yoga may be an effective intervention. The primary objective was to determine the feasibility of individualized yoga for hospitalized children receiving intensive chemotherapy. METHODS: We included English-speaking children and adolescents aged 7-18 years receiving intensive chemotherapy or haematopoietic stem cell transplantation (HSCT). Yoga was conducted three times weekly for three weeks. The primary outcome was feasibility, defined as ability to deliver at least 60% of planned sessions. Secondary outcomes were parent-reported Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale, Fatigue Scale-Parent, PedsQL Generic Core Scales and PedsQL Acute Cancer Module. RESULTS: Between January and October 2013, 11 patients were enrolled. Median age was 14.0 (range 7.7-16.4) years and 6 (55%) were boys. Yoga was feasible with 10/11 participants meeting the threshold for feasibility. The median number of yoga sessions was 9 (range 3-13). No adverse events were attributed to yoga. Mean±standard deviation for the day 21 proxy-reported PedsQL general fatigue scores was 55.6±15.5. Qualitative comments suggested design changes for future yoga studies. CONCLUSIONS: Individualized yoga is feasible for inpatient children receiving intensive chemotherapy. Future work will include development and conduct of a randomized trial for fatigue amelioration. TRIAL REGISTRATION: ClinicalTrials.gov NCT02105389.

Development and initial evaluation of electronic Children's International Mucositis Evaluation Scale (eChIMES) for children with cancer.

PURPOSE: We previously developed a pediatric-specific measure of oral mucositis named the Children's International Mucositis Evaluation Scale (ChIMES). Availability as an electronic version may improve self-report response rates. The objectives were to develop an electronic version of ChIMES (eChIMES) and to determine whether the instrument is easy to use, understandable, and suitable for measuring mucositis among children and adolescents with cancer. METHODS: Development of eChIMES was on an iPad; the initial version was piloted with ten children to refine instructions for use and presentation. A crosssectional study then was conducted and included English-speaking children and adolescents 8-18 years of age receiving active treatment for cancer. Participants were shown eCHIMES and were asked to complete it. Questions elicited whether they found eChIMES easy or difficult to use, easy or difficult to understand, and suitable (a good way) for children with cancer to monitor mucositis. Outcomes were rated using five-point ordinal scales. RESULTS: Following the development and initial refinement of eChIMES, 40 children were enrolled. Median age was 12.4 (range, 8.0 to 17.8) years. The instrument was found to be easy or very easy to use and understood by 40 (100 %) and 38 (95 %) participants, respectively. The application was considered suitable or very suitable for measuring mucositis by 37 (92 %). CONCLUSIONS: We found that eChIMES was easy to use, understandable, and suitable for monitoring mucositis among children with cancer. Incorporation into clinical trials may improve the ability to compare and evaluate interventions for mucositis.

Initial development of the Symptom Screening in Pediatrics Tool (SSPedi).

BACKGROUND: We previously identified published scales for symptom assessment in pediatric cancer patients. The objectives of this study were to identify if any of these scales were suitable for use or adaptation as a self-report symptom screening tool, and if not, to begin the process of creating a new tool. METHODS: A focus group of ten healthcare professionals with expertise in pediatric cancer symptom management and a patient advocate were convened. First, the group identified the optimal properties of a symptom screening tool for pediatric cancer patients. Next, the previously identified symptom assessment scales were evaluated against these properties. As none of the existing scales were adequate for symptom screening, a nominal group technique was used to identify the most important symptoms for inclusion in a new symptom screening tool. RESULTS: Optimal properties of a symptom screening tool included minimal respondent burden, inclusion of 15 items or less, and inclusion of the most burdensome symptoms. None of the previously identified scales were adequate because they lacked content validity and were too long or would be too hard for children to understand. Nominal group technique identified 15 items to be included; an initial draft was developed and named the Symptom Screening in Pediatrics (SSPedi) Tool. CONCLUSIONS: This study identified the lack of an appropriate symptom screening tool for use by pediatric cancer patients. A preliminary version of SSPedi was developed. Subsequent work will ensure that it is understandable by children and evaluate its psychometric properties.

Randomized trial of dyadic-report vs proxy-report and self-report symptom assessment for pediatric patients receiving cancer treatments.

BACKGROUND: We validated different approaches to symptom assessment for pediatric cancer patients based on the Symptom Screening in Pediatrics Tool (SSPedi) for self-report (SSPedi and mini-SSPedi), proxy-report (proxy-SSPedi), and structured dyadic-report (co-SSPedi). The objective was to compare co-SSPedi scores vs proxy-report (proxy-SSPedi) and self-report (SSPedi or mini-SSPedi) scores for pediatric patients receiving cancer treatments. METHODS: This was a single-center, randomized crossover study enrolling English-speaking dyads of pediatric patients with cancer or hematopoietic cell transplant recipients 4-18 years old and their guardians. Dyads were randomized to first complete the dyadic-report (co-SSPedi) or self-report (patients: SSPedi or mini-SSPedi) and proxy-report (guardians: proxy-SSPedi). Dyads then crossed over to the alternate approach. Primary analysis compared total SSPedi scores between randomized groups. RESULTS: We enrolled 420 dyads that were randomized to co-SSPedi first (n = 213) or proxy-SSPedi and self-report SSPedi first (n = 207). Mean total SSPedi scores (± standard deviation) were co-SSPedi (9.6 ± 7.1), proxy-SSPedi (9.7 ± 7.5; P = .950 for comparison vs co-SSPedi), and self-report SSPedi (9.7 ± 8.2; P = .981 for comparison vs co-SSPedi). Co-SSPedi scores were significantly different from proxy-SSPedi for feeling disappointed or sad, feeling cranky or angry, feeling tired, mouth sores, and changes in taste. Co-SSPedi scores were significantly different from self-report SSPedi scores for problems with thinking or remembering things, feeling tired, mouth sores, tingly or numb hands or feet, and diarrhea. CONCLUSIONS: Total co-SSPedi scores were not significantly different compared with proxy-report or self-report scores, although there were differences in specific symptom scores. If different reporter types are used during clinical implementation, specifying reporter type will be important. The study was registered at clinicaltrials.gov (NCT #05012917). Symptoms are common and frequently severely bothersome in pediatric patients with cancer and hematopoietic cell transplant (HCT) recipients (1). To measure the extent of bothersome symptoms, the Symptom Screening in Pediatrics Tool (SSPedi) suite of symptom assessment tools was developed for pediatric patients receiving cancer treatments and currently consists of multiple validated instruments. SSPedi was developed for self-report by patients 8-18 years of age (2,3). Mini-SSPedi was developed for self-report by patients 4 to 7 years of age (4). Proxy-SSPedi was developed for proxy-report by guardians of pediatric patients 2-18 years of age (5). These 3 instruments can be categorized as either self-report (SSPedi or mini-SSPedi) or proxy-report (proxy-SSPedi).