Assessment of longitudinal changes in body composition of children with lymphoma and rhabdomyosarcoma.

BACKGROUND: Studies examining changes in skeletal muscle and adipose tissue during treatment for cancer in children, adolescents, and young adults and their effect on the risk of chemotherapy toxicity (chemotoxicity) are limited. METHODS: Among 78 patients with lymphoma (79.5%) and rhabdomyosarcoma (20.5%), changes were measured in skeletal muscle (skeletal muscle index [SMI]; skeletal muscle density [SMD]) and adipose tissue (height-adjusted total adipose tissue [hTAT]) between baseline and first subsequent computed tomography scans at the third lumbar vertebral level by using commercially available software. Body mass index (BMI; operationalized as a percentile [BMI%ile]) and body surface area (BSA) were examined at each time point. The association of changes in body composition with chemotoxicities was examined by using linear regression. RESULTS: The median age at cancer diagnosis of this cohort (62.8% male; 55.1% non-Hispanic White) was 12.7 years (2.5-21.1 years). The median time between scans was 48 days (range, 8-207 days). By adjusting for demographics and disease characteristics, this study found that patients undergo a significant decline in SMD (ß ± standard error [SE] = -4.1 ± 1.4; p < .01). No significant changes in SMI (ß ± SE = -0.5 ± 1.0; p = .7), hTAT (ß ± SE = 5.5 ± 3.9; p = .2), BMI% (ß ± SE = 4.1 ± 4.8; p = .3), or BSA (ß ± SE = -0.02 ± 0.01; p = .3) were observed. Decline in SMD (per Hounsfield unit) was associated with a greater proportion of chemotherapy cycles with grade ≥3 nonhematologic toxicity (ß ± SE = 1.09 ± 0.51; p = .04). CONCLUSIONS: This study shows that children, adolescents, and young adults with lymphoma and rhabdomyosarcoma undergo a decline in SMD early during treatment, which is associated with a risk of chemotoxicities. Future studies should focus on interventions designed at preventing the loss of muscle during treatment. PLAIN LANGUAGE SUMMARY: We show that among children, adolescents, and young adults with lymphoma and rhabdomyosarcoma receiving chemotherapy, skeletal muscle density declines early during treatment. Additionally, a decline in skeletal muscle density is associated with a greater risk of nonhematologic chemotoxicities.

Children's Oncology Group KidsCare smartphone application for parents of children with cancer.

BACKGROUND: Parents of children with cancer must learn and retain crucial information necessary to provide safe care for their child. Smartphone applications (apps) provide a significant opportunity to meet the informational needs of these parents. We aimed to develop, refine, and evaluate a smartphone app, informed by the Children's Oncology Group (COG) expert consensus recommendations, to support the informational needs of parents of children with cancer. PROCEDURE: We employed a user-centered iterative mixed-methods approach in two phases (prototype development/refinement and pilot testing). We engaged parents and clinicians in evaluating the app via qualitative interviews and standardized tools that measured app quality (Mobile Application Rating Scale [MARS]), usability (System Usability Scale [SUS]), and acceptability (System Acceptability Scale [SAS]). We evaluated early usage patterns after public release. RESULTS: Thirty-two parents and 17 clinicians participated. Mean (± standard deviation [SD]) scores for app quality, usability, and acceptability were: MARS: 4.5 ± 0.7 on a 5-point scale; SUS: 86.7 ± 23.8 on a 100-point scale; and SAS: superior (61%); similar (28%); inferior (11%) to written materials. Qualitative findings largely confirmed the quantitative data. Downloads of the app during the first year following public release have exceeded 5000. CONCLUSIONS: The COG KidsCare app prototype was found to be of high quality and received high usability and acceptability ratings. Further testing is needed to determine app effectiveness in improving parental knowledge regarding care of children with cancer.

A Structured Discharge Education Intervention for Parents of Newly Diagnosed Pediatric Oncology Patients.

Background: Parents of children newly diagnosed with cancer require specialized knowledge and skills in order to safely care for their children at home. The Children's Oncology Group (COG) developed expert consensus recommendations to guide new diagnosis education; however, these recommendations have not been empirically tested. Methods: We used a sequential two-cohort study design to test a nurse-led Structured Discharge Teaching Intervention (SDTI) that operationalizes the COG expert recommendations in the setting of a tertiary children's hospital. Outcomes included parent Readiness for Hospital Discharge Scale (RHDS); Quality of Discharge Teaching Scale (QDTS); Post-Discharge Coping Difficulty (PDCD); Nurse Satisfaction; and post-discharge unplanned healthcare utilization. Results: The process for discharge education changed significantly before and after implementation of the SDTI, with significantly fewer instances of one-day discharge teaching, and higher involvement of staff nurses in teaching. Overall, parental RHDS, QDTS, and PDCD scores were similar in the unintervened and intervened cohorts. Almost 60% of patients had unplanned healthcare encounters during the first 30 days following their initial hospital discharge. Overall nurse satisfaction with the quality and process of discharge education significantly increased post-intervention. Discussion: Although the structure for and process of delivering discharge education changed significantly with implementation of the SDTI, parent RHDS and QDTS scores remained uniformly high and PDCD scores and non-preventable unplanned healthcare utilization remained similar, while nurse satisfaction with the quality and process of discharge education significantly improved, suggesting that further testing of the SDTI across diverse pediatric oncology settings is warranted.

The New Oncologic Diagnosis Discussion: Perspectives of Pediatric Oncologists.

PURPOSE: We aimed to understand how new diagnosis discussions are conducted in pediatric oncology, and the training provided for their conduct. METHODS: This mixed-methods study used a sequential exploratory design. Qualitative interviews (n = 20) were conducted with pediatric oncologists (n = 15) and fellows (n = 5) at a single institution, focusing on the process used to convey the diagnosis and treatment plan to the family. Accreditation Council for Graduate Medical Education-accredited pediatric oncology fellowship program directors (n = 38) and fellows (n = 70) were subsequently surveyed to confirm qualitative results and elucidate the training that fellows receive in conducting new diagnosis discussions. RESULTS: Our findings suggest that new diagnosis discussions in pediatric oncology are typically conducted in three stages: (1) concern for cancer; (2) confirmation of diagnosis; and (3) treatment plan/consent, and are fundamentally similar across settings; however, pediatric oncologists skillfully tailor their approach on the basis of clinical circumstances and parental needs. Decisions regarding inclusion of the child are primarily determined by parental preference, whereas inclusion of health care team members is driven by physician role (ie, trainee v program director) and health care organization-related factors. Physician preparation for discussions involves logistical, intellectual, and emotional components. Disclosure of prognosis is nuanced. There is variability across pediatric oncology fellowship programs in the provision of training for these discussions. CONCLUSION: We identified common practices of pediatric oncologists as they prepare for and lead new diagnosis discussions in pediatric oncology. We found variability in the training that pediatric oncology fellows receive regarding how to conduct these discussions, highlighting a need for standardized training curricula.

Immunogenicity and safety of the human papillomavirus vaccine in young survivors of cancer in the USA: a single-arm, open-label, phase 2, non-inferiority trial.

BACKGROUND: Young survivors of cancer are at increased risk for cancers that are related to human papillomavirus (HPV), primarily caused by oncogenic HPV types 16 and 18. We aimed to examine the immunogenicity and safety of the three-dose series of HPV vaccine in young survivors of cancer. METHODS: We conducted an investigator-initiated, phase 2, single-arm, open-label, non-inferiority trial at five National Cancer Institute-designated comprehensive cancer centres in the USA. Eligible participants were survivors of cancer who were HPV vaccine-naive, were aged 9-26 years, in remission, and had completed cancer therapy between 1 and 5 years previously. Participants received three intramuscular doses of either quadrivalent HPV vaccine (HPV4; enrolments on or before March 1, 2016) or nonavalent HPV vaccine (HPV9; enrolments after March 1, 2016) over 6 months (on day 1, at month 2, and at month 6). We also obtained data from published clinical trials assessing safety and immunogenicity of HPV4 and HPV9 in 9-26-year-olds from the general population, as a comparator group. The primary endpoint was antibody response against HPV types 16 and 18 at month 7 in the per-protocol population. A response was deemed non-inferior if the lower bound of the multiplicity-adjusted 95% CI was greater than 0·5 for the ratio of anti-HPV-16 and anti-HPV-18 geometric mean titres (GMTs) in survivors of cancer versus the general population. Responses were examined separately in male and female participants by age group (ie, 9-15 years and 16-26 years). Safety was assessed in all participants who received at least one vaccine dose and for whom safety data were available. This study is registered with ClinicalTrials.gov, NCT01492582. This trial is now completed. FINDINGS: Between Feb 18, 2013, and June 22, 2018, we enrolled 453 survivors of cancer, of whom 436 received one or more vaccine doses: 203 (47%) participants had survived leukaemia, 185 (42%) were female, and 280 (64%) were non-Hispanic white. Mean age at first dose was 15·6 years (SD 4·6). 378 (83%) of 453 participants had evaluable immunogenicity data; main reasons for exclusion from per-protocol analysis were to loss to follow-up, patient reasons, and medical reasons. Data were also obtained from 26 486 general population controls. The ratio of mean GMT for anti-HPV types 16 and 18 in survivors of cancer versus the general population was more than 1 for all subgroups (ie, aged 9-15 years, aged 16-26 years, male, and female groups) in both vaccine cohorts (ranging from 1·64 [95% CI 1·12-2·18] for anti-HPV type 16 in female participants aged 9-15 years who received HPV9, to 4·77 [2·48-7·18] for anti-HPV type 18 in male participants aged 16-26 years who received HPV4). Non-inferiority criteria were met within each age and sex subgroup, except against HPV type 18 in female participants aged 16-26 years receiving HPV9 (4·30 [0·00-9·05]). Adverse events were reported by 237 (54%) of 435 participants; injection site pain was most common (174 [40%] participants). One serious adverse event (ie, erythema nodosum) was possibly related to vaccine (HPV9; 16-26 year female cohort). INTERPRETATION: Immunogenicity and safety of HPV vaccine three-dose series in survivors of cancer is similar to that in the general population, providing evidence for use in this clinically vulnerable population. FUNDING: US National Cancer Institute, Merck, Sharp & Dohme, and American Lebanese Syrian Associated Charities.

Association between body composition and chemotherapy-related toxicity in children with lymphoma and rhabdomyosarcoma.

BACKGROUND: Body composition is associated with chemotherapy toxicity (chemotoxicity) in adults with cancer; this association remains unexplored in children with cancer. METHODS: Using baseline computed tomography scans of 107 children with Hodgkin lymphoma (n = 45), non-Hodgkin lymphoma (n = 42), or rhabdomyosarcoma (n = 20), this study examined body composition (skeletal muscle index [SMI], skeletal muscle density [SMD], and height-adjusted total adipose tissue [hTAT]) to determine its association with chemotoxicity. Clinical characteristics and chemotoxicities were abstracted from medical records. Primary outcomes included grade 4 or higher hematologic toxicities and grade 3 or higher nonhematologic toxicities within 6 months of the diagnosis. Logistic regression models accounting for repeated measures were constructed to examine the association between body composition indices and chemotoxicities; adjustments were made for age at diagnosis, sex, race/ethnicity, cancer type, risk group, body mass index (measured as a percentile), or body surface area. RESULTS: The median SMI was 41.0 cm2 /m2 (range, 25.8-68.6 cm2 /m2 ), the median SMD was 54.1 HU (range, 35-69.4 HU), and the median hTAT was 19.5 cm2 /m2 (range, 0-226.7 cm2 /m2 ). Grade 4 or higher hematologic toxicities and grade 3 or higher nonhematologic toxicities were observed in 74.7% and 66.3% of the chemotherapy cycles, respectively. A higher SMD at diagnosis was associated with lower odds of grade 4 or higher hematologic toxicity (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.85-0.97; P = .004). SMI (OR, 0.99; 95% CI, 0.95-1.04; P = .7) and hTAT (OR, 1.00; 95% CI, 0.99-1.01; P = .9) were not associated with hematologic toxicities. Nonhematologic toxicities did not show any association with body composition. CONCLUSIONS: The association between low SMD and hematologic toxicities in children with lymphoma or rhabdomyosarcoma could be due to body composition-based biodistribution of chemotherapeutic agents and needs further investigation. LAY SUMMARY: Body composition at cancer diagnosis in children with lymphoma and rhabdomyosarcoma may provide information that could identify those at risk for serious side effects from chemotherapy. Routinely used measures such as body mass index and body surface area show poor correlations with body composition assessed via computed tomography scans.