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.

Intent and subsequent initiation of human papillomavirus vaccine among young cancer survivors.

BACKGROUND: Despite an increased risk of subsequent human papillomavirus (HPV)-related malignancies, HPV vaccine initiation rates among cancer survivors remain critically low. The purpose of this study was to determine the relationship between HPV vaccine intent and subsequent vaccine initiation among cancer survivors by linking data from a cross-sectional survey with state-based immunization registry records. METHODS: Cancer survivors who were 9 to 26 years old were surveyed 1 to 5 years after their treatment to assess their HPV vaccine initiation status, HPV vaccine intent, sociodemographic factors, and vaccine-related health beliefs. HPV vaccine doses/dates were abstracted from the Georgia Registry for Immunization Transactions for 3.5 years after survey participation. Logistic regression models identified factors associated with vaccine intent and subsequent vaccine initiation. RESULTS: Among survivors who were HPV vaccine-naive at survey participation (n = 103), factors associated with vaccine intent included the following: 1) provider recommendation for the HPV vaccine (odds ratio [OR], 5.0; 95% confidence interval [CI], 1.4-18.1; P = .014), 2) positive general attitude toward vaccines (OR, 4.8; 95% CI, 2.0-11.2; P < .001), and 3) perceived severity of HPV disease (OR, 3.5; 95% CI, 1.2-9.9; P = .02). Of the vaccine-naive patients, 28 initiated the HPV vaccine at a median of 1.1 years after the survey. Initiation was more likely among survivors who had reported vaccine intent (OR, 3.9; 95% CI, 1.2-12.5; P = .02) and was less likely among older survivors (OR per year, 0.7; 95% CI, 0.6-0.9; P < .001). CONCLUSIONS: These findings suggest that provider recommendation for the HPV vaccine plays a role in establishing intent, which then translates into subsequent initiation.

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.

Health Literacy in Parents of Children Newly Diagnosed With Cancer and Comprehension of Key Concepts Related to Their Child's Care.

Background: There is a paucity of literature regarding health literacy in pediatric oncology. We sought to understand the relationship between health literacy and comprehension of key new diagnosis education concepts in parents of children newly diagnosed with cancer. Methods: Using data from a study evaluating a structured new diagnosis discharge teaching intervention, we performed a secondary analysis to understand the relationship between parental health literacy (Brief Health Literacy Screener: BHLS) and comprehension of six key concepts (child's diagnosis, primary oncologist, and treatment plan; seeking emergent care; fever definition; re-dosing medication). We also evaluated the association between parents self-reported sociodemographic characteristics, preferred learning style (one-item ordinal assessment) and health literacy. We tested relationships using Fisher's exact tests, independent samples t-tests, and Pearson correlations. Results: Fifty parents participated (age 35.4 ± 8.2 years [M ± SD]; 86% female; 60% non-Hispanic white; 24% with ≤high school education); nine parents (18%) scored in the BHLS low literacy range; 80% correctly responded to all six items on the key concepts questionnaire (100% comprehension). Health literacy was not significantly related to 100% comprehension or to individual key concept responses, with the exception of "child's treatment plan" (correct responses: 55.6% in low vs. 100% in adequate literacy groups; p < .001). Parental sociodemographic characteristics and preferred learning styles were not significantly related to health literacy. Discussion:Despite variability in health literacy levels, 80% of the parents comprehended all key concepts, suggesting that the intervention was effective for most parents, regardless of health literacy level.

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.

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.

Sexual behaviors and human papillomavirus vaccine non-initiation among young adult cancer survivors.

BACKGROUND: Young adult cancer survivors are at risk for subsequent human papillomavirus (HPV)-related malignancies. High-risk sexual behavior increases risk for HPV acquisition; HPV vaccination protects against infection. We aimed to determine the prevalence of sexual behaviors, factors related to high-risk sexual behaviors, and the relationship between sexual behaviors and HPV vaccine non-initiation among survivors. METHODS: Survivors at comprehensive cancer centers, aged 18-26 years and 1-5 years post-treatment, reported sexual behaviors and HPV vaccine initiation (i.e., ≥ 1 dose). Multivariable logistic regression was performed to calculate odds ratios (OR) and 95% confidence intervals (95%CI) for factors associated with high-risk sexual behaviors (age at first intercourse < 16 years, ≥ 3 lifetime sexual partners, or condom use ≤ 50% of the time) and to explore the relationship between sexual behaviors and vaccine non-initiation. RESULTS: Of the 312 participants (48.1% female, median age at cancer diagnosis 17.2 years and at survey 20.9 years), sexual intercourse was reported by 63.1%. Of those reporting intercourse, 74.6% reported high-risk sexual behavior. Factors related to high-risk sexual behavior included currently dating/partnered (OR = 4.39, 95%CI 2.5-7.7, P < 0.001) and perceived susceptibility to HPV (OR = 1.76, 95%CI 1.3-2.5, P < 0.001). Most survivors (75.3%) reported HPV vaccine non-initiation; sexual behaviors were not associated with vaccine non-initiation (P = 0.4). CONCLUSIONS: Many survivors participate in high-risk sexual behaviors, yet HPV vaccine initiation rates are low. Factors related to high-risk sexual behaviors can inform interventions to reduce risk for HPV acquisition among survivors. IMPLICATIONS FOR CANCER SURVIVORS: Cancer survivors participate in sexual behaviors that increase risk for HPV acquisition and would benefit from vaccination.

Patient-Level Factors Associated With Lack of Health Care Provider Recommendation for the Human Papillomavirus Vaccine Among Young Cancer Survivors.

PURPOSE: Young cancer survivors are at increased risk for morbidities related to infection with the human papillomavirus (HPV), yet their HPV vaccine initiation rates remain low. Patient-/parent-reported lack of health care provider recommendation for HPV vaccination is strongly associated with vaccine noninitiation. We aimed to identify patient-level factors associated with survivor-/parent-reported lack of provider recommendation for HPV vaccination among young cancer survivors. METHODS: Cancer survivors ages 9-26 years and 1-5 years off therapy completed a cross-sectional survey (parent-completed for survivors 9-17 years of age). Lack of health care provider HPV vaccine recommendation was the outcome of interest in a multivariable logistic regression model that included relevant patient-level sociodemographic, clinical, and vaccine-related variables. RESULTS: Of 955 survivors, 54% were male, 66% were non-Hispanic White, and 36% had leukemia. At survey participation, survivors were an average age (± standard deviation) of 16.3 ± 4.7 years and 32.8 ± 14.7 months off therapy. Lack of provider HPV vaccine recommendation was reported by 73% (95% CI, 70% to 75%) of survivors. For the entire cohort, patient-level factors associated with lack of reported provider recommendation included perceived lack of insurance coverage for the HPV vaccine (odds ratio [OR], 4.0; 95% CI, 2.7 to 5.9; P < .001), male sex (OR, 2.8; 95% CI, 1.9 to 4.0; P < .001), and decreased parent-survivor communication regarding HPV vaccination (OR, 1.7 per unit decrease in score; 95% CI, 1.3 to 2.2; P < .001). In the sex- and age-stratified models, perceived lack of insurance coverage (all models) and male sex (age-stratified models) were also significantly associated with lack of reported provider recommendation. CONCLUSION: We identified factors characterizing survivors at risk for not reporting receipt of a health care provider HPV vaccine recommendation. Future research is needed to develop interventions that facilitate effective provider recommendations for HPV vaccination among all young cancer survivors.

Human Papillomavirus Vaccination Rates in Young Cancer Survivors.

Purpose: Cancer survivors are at high risk for human papillomavirus (HPV)-related morbidities; we estimated the prevalence of HPV vaccine initiation in cancer survivors versus the US population and examined predictors of noninitiation. Methods: Participants included 982 cancer survivors (9 to 26 years of age; 1 to 5 years postcompletion of therapy); we assessed HPV vaccine initiation, sociodemographic and clinical characteristics, and vaccine-specific health beliefs; age-, sex-, and year-matched US population comparisons were from the National Immunization Survey-Teen and the National Health Interview Survey (2012-2015). Results: The mean age at the time of the study was 16.3 ± 4.7 years; the mean time off therapy was 2.7 ± 1.2 years; participants were 55% male and 66% non-Hispanic white; 59% had leukemia/lymphoma. Vaccine initiation rates were significantly lower in cancer survivors versus the general population (23.8%; 95% CI, 20.6% to 27.0% v 40.5%; 95% CI, 40.2% to 40.7%; P < .001); survivors were more likely to be HPV vaccine-naïve than general population peers (odds ratio [OR], 1.72; 95% CI, 1.41 to 2.09; P < .001). Initiation in adolescent survivors (ages 13 to 17 years) was 22.0% (95% CI, 17.3% to 26.7%), significantly lower than population peers (42.5%; 95% CI, 42.2% to 42.8%; P < .001). Initiation in young adult survivors and peers (ages 18 to 26 years) was comparably low (25.3%; 95% CI, 20.9% to 29.7% v 24.2%; 95% CI, 23.6% to 24.9%). Predictors of noninitiation included lack of provider recommendation (OR, 10.8; 95% CI, 6.5 to 18.0; P < .001), survivors' perceived lack of insurance coverage for HPV vaccine (OR, 6.6; 95% CI, 3.9 to 11.0; P < .001), male sex (OR, 2.9; 95% CI, 1.7 to 4.8; P < .001), endorsement of vaccine-related barriers (OR, 2.7; 95% CI, 1.6 to 4.6; P < .001), and younger age (9 to 12 years; OR, 3.7; 95% CI, 1.8-7.6; P < .001; comparison, 13 to 17 years). Conclusion: HPV vaccine initiation rates in cancer survivors are low. Lack of provider recommendation and barriers to vaccine receipt should be targeted in vaccine promotion efforts.