Classification of treatment-related mortality in children with cancer: a systematic assessment.

Treatment-related mortality is an important outcome in paediatric cancer clinical trials. An international group of experts in supportive care in paediatric cancer developed a consensus-based definition of treatment-related mortality and a cause-of-death attribution system. The reliability and validity of the system was tested in 30 deaths, which were independently assessed by two clinical research associates and two paediatric oncologists. We defined treatment-related mortality as death occurring in the absence of progressive cancer. Of the 30 reviewed deaths, the reliability of classification for treatment-related mortality was noted as excellent by clinical research associates (κ=0·83, 95% CI 0·60-1·00) and paediatric oncologists (0·84, 0·63-1·00). Criterion validity was established because agreement between the consensus classifications by clinical research associates and paediatric oncologists was almost perfect (0·92, 0·78-1·00). Our approach should allow comparison of treatment-related mortality across trials and across time.

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.

Facilitating accrual to cancer control and supportive care trials: the clinical research associate perspective.

BACKGROUND: Accrual to Cancer Control and Supportive Care (CCL) studies can be challenging. Our objective was to identify facilitators and perceived barriers to successful Children's Oncology Group (COG) CCL accrual from the clinical research associate (CRA) perspective. METHODS: A survey was developed that focused on the following features from the institutional perspective: (1) Components of successful accrual; (2) Barriers to accrual; (3) Institutional changes that could enhance accrual; and (4) How COG could facilitate accrual. The survey was distributed to the lead CRA at each COG site with at least 2 CCL accruals within the previous year. The written responses were classified into themes and sub-themes. RESULTS: 57 sites in the United States (n = 52) and Canada (n = 5) were contacted; 34 (60%) responded. The four major themes were: (1) Staff presence and dynamics; (2) Logistics including adequate numbers of eligible patients; (3) Interests and priorities; and (4) Resources. Suggestions for improvement began at the study design/conception stage, and included ongoing training/support and increased reimbursement or credit for successful CCL enrollment. CONCLUSIONS: The comments resulted in suggestions to facilitate CCL trials in the future. Soliciting input from key team members in the clinical trials process is important to maximizing accrual rates.

A systematic review of symptom assessment scales in children with cancer.

BACKGROUND: The objective was to describe symptom assessment scales that have been used in children with cancer. METHODS: We conducted electronic searches of OVID Medline and EMBASE in order to identify all symptom assessment scales that have been used in pediatric cancer. Two reviewers abstracted information from each identified study. Data collected included study demographics and information related to the instrument and children enrolled. We also collected information about the purpose of instrument administration and whether treatment was altered as a result of this information. RESULTS: Fourteen studies were identified which evaluated eight different symptom assessment scales. Eight studies used child self-report and all studies included children on active treatment for cancer although 4 studies also included children following completion of treatment. The most common purpose of instrument administration was to measure the prevalence of symptom burden (n = 8). None of the 14 studies used the scale to screen for symptoms and none changed patient management on the basis of identified symptoms. CONCLUSIONS: We failed to identify any symptom assessment scales that were used as a symptom screening tool. There is a need to develop such a tool for use in children with cancer.

Complementary and alternative medicine use in pediatric cancer reported during palliative phase of disease.

PURPOSE: The objectives of this study were to assess the frequency, types, and potential determinants of complementary and alternative medicine (CAM) use, and consideration of CAM use, collected from parents with children during the palliative phase of disease. METHODS: Eligible parent respondents were identified by their primary care team. Demographic information and questionnaires were completed by the parent in the presence of a research nurse (DT). We conducted univariate logistic regression to identify predictors of parents who considered CAM use and children who actually used CAM. Descriptions of types of CAM were categorized according to the National Center for Complementary and Alternative Medicine. RESULTS: A total of 77 parents participated. Only 22 children (29%) had received some type of CAM, with 42 parents (55%) having considered its use for their child. Whole medical systems (n = 17) and biologically based therapies (n = 15) were the most frequently considered CAM, with whole medical systems (n = 6) being the most frequently used CAM. Family and disease variables were not indicative of CAM use. However, parents with higher education and those with a family member with cancer were more likely to consider CAM use, while parents were less likely to consider CAM as children were farther from time of relapse. CONCLUSIONS: The study provides initial insight into CAM use, and consideration of use, in children with cancer receiving palliative care. Further research is required to determine if the gap between CAM use and consideration is important, why this gap exists, and whether CAM has beneficial effects in this population.

Development of an Individualized Yoga Intervention to Address Fatigue in Hospitalized Children Undergoing Intensive Chemotherapy.

Purpose Fatigue is an important problem in children receiving intensive chemotherapy and hematopoietic stem cell transplantation (HSCT). Exercise may be an effective intervention for fatigue. Individualized yoga represents an ideal intervention because it can be tailored according to an individual child's needs. Little is known about how to structure a standardized yoga program for intensivelytreated children. Therefore, this study describes the development of a yoga program and an approach to monitoring sessions suitable for hospitalized children receiving intensive chemotherapy or HSCT. Methods The yoga program was designed to increase mobility in hospitalized children and to provide children with relaxation techniques that could be used independently in a variety of environments. The program was founded on 4 key tenets: safety, adaptability, environmental flexibility, and appeal to children. We also developed quality and consistency assurance procedures. Results A menu format with a fixed structure was selected for the yoga program. Each yoga session contained up to 6 sections: breathing exercises, warmup exercises, yoga poses, balancing poses, cool-down poses, and final relaxation. Yoga instructors selected specific yoga poses for each session from a predetermined list organized by intensity level (low, moderate, or high). Monitoring procedures were developed using videotaping and multirater adjudication. Conclusion We created a standardized yoga program and an approach to monitoring that are now ready for incorporation in clinical trials. Future work should include the adaptation of the program to different pediatric populations and clinical settings.