The primary aim of this study is to assess the implementation of the EMERGE model of care in 2 Australian pediatric cancer centers across a range of indicators, including reach, acceptability, satisfaction, maintenance, and barriers and facilitators to participation.

The secondary aim of the study is to evaluate the clinical effectiveness of the EMERGE model of care, including (1) participant satisfaction, (2) reduction in unmet information needs, and (3) reduction in parent or caregiver stress.

An exploratory aim of this study is to evaluate the costs of providing EMERGE and explore a sustainable model to upscale the program to all patients and families diagnosed and treated for childhood cancer in Victoria, Australia.

This study will be conducted at the Children’s Cancer Centers at The Royal Children’s Hospital (RCH; parent site) and the Monash Children’s Hospital (MCH; satellite site) in Melbourne, Australia. These 2 centers are responsible for coordinating the care of all children and young people aged 0‐18 years diagnosed with cancer in the state of Victoria, Australia.

This implementation study will use a mixed methods approach to develop and evaluate the EMERGE end-of-treatment model of care. A type 2 nonrandomized hybrid trial will be used. A hybrid design advances knowledge of both the intervention and the implementation factors associated with integration into clinical practice [34].

This study has a dual focus of assessing (1) the implementation outcomes of the EMERGE model of care in real-world settings across 2 institutional sites, and (2) the clinical effectiveness of the EMERGE model of care using a within-subject pre-post design.

The study is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework [35]. RE-AIM emphasizes the translation of research into practice and the importance of considering context in intervention planning and design. It provides a framework to assess what intervention components are effective, for whom and in which settings, and with which implementation strategies [36]. RE-AIM theorizes that the impact of an intervention is a function of 5 systems based on socioecological factors, that is, reach, efficacy, adoption, implementation, and maintenance. The proposed evaluation embedded within this protocol addresses these 5 factors.

Before study activation and participant enrollment, the study protocol was approved by the RCH Human Ethics and Research Committee (78840). Informed consent is obtained from all participants aged 16 years and older. Parental consent will be obtained for children younger than 18 years of age. All data are securely stored on servers and software approved for the use of protected health information. Additionally, data are deidentified upon collection and stored under a study identification number. Participants did not receive compensation for participation in this trial.

Children and adolescents aged between 2 and 18 years (or older if receiving active surveillance in the pediatric setting), who are completing treatment for pediatric ALL at 1 of the 2 cancer centers (RCH and MCH), and a parent caregiver will be invited to participate in the study. Patients who have completed treatment for lymphoblastic lymphoma are also eligible for this study, as they present with the same disease features and undergo the same treatment protocols as patients with ALL. Given the high similarities shared by these disease entities, and for ease of reference, we will refer to patients with ALL in this protocol. Refer to Table 1 for participant criteria.

Children and adolescents with ALL, being treated with curative intent (in the nonrelapse or refractory setting) and who have recently completed treatment or are nearing the end of treatment will be identified during routine multidisciplinary team meetings undertaken weekly at the RCH and MCH cancer centers. Families identified as potential participants will be introduced to the program by their treating oncologist and provided with a study brochure. For families who do not opt out of the study, a member of the research team will contact the primary caregiver directly to obtain written consent to participate in the study. Adolescents will be approached to provide consent if they are determined to have appropriate literacy ability and cognitive capacity to understand the requirements of the intervention. Competency will be determined by talking to the treating team and in consultation with parents and caregivers. For culturally and linguistically diverse families, interpreter services can be accessed to assist with the introduction and enrollment of families into the study. We will also encourage families to include a support person in this process if they find this helpful.

Health care providers and organizational stakeholders will be approached directly by the research team to participate in the project. For data that are collected directly from study participants (eg, questionnaires), the participant will need to provide electronic consent via REDCap (Research Electronic Data Capture; Vanderbilt University). REDCap is a secure, web-based software platform designed to support data capture for research studies [37,38].

The EMERGE model of care will offer families a minimum of 2 telehealth (video conference) consultations during the first 12 months of their child completing treatment for ALL. The EMERGE program is cofacilitated by an advanced practice nurse and psychosocial clinician who have been trained in the implementation of the intervention. A telehealth platform was chosen to address barriers identified for attending appointments (eg, burden of attending the hospital, desire to avoid health settings, and disruption to school attendance) and to increase the opportunity to deliver the intervention regardless of geographical location from the hospital. Telehealth has strong organizational support from the hospitals and offers a flexible, safe, and potentially cost-effective framework to screen and monitor families in the off-treatment period [39,40].

The EMERGE model is based upon the Pediatric Psychosocial Preventative Healthcare Model, a 3-tier model of universal, targeted, and clinical categorization that represents the distribution of psychosocial risk across family populations [41]. The EMERGE model also incorporates the recommendations of the Standards for the Psychosocial Care of Children with Cancer and Their Families, developed in 2015 [42], by specifically including components, such as psychosocial screening, psychoeducation, monitoring and review, and specialist interventions (Figure 1).

The key components of the EMERGE model are presented below.

First, identification of eligible participants via the clinical team and informed consent obtained by the EMERGE research team.

Second, treatment summary and surveillance roadmap: these documents will be prepared by the EMERGE advanced practice nurse and validated by the patient’s primary oncologist. The treatment summary includes the child’s initial presentation, significant medical and family cancer history, the treatment protocol delivered, diagnostic criteria (including criteria for risk stratification), cumulative chemotherapy doses, significant treatment toxicities, and any clinical trial participation. The surveillance summary provides a schedule of the necessary tests, investigations, and physical examinations over the corresponding 5-year period. These documents provide a narrative for the nurse to revisit the diagnosis and treatment with the participants, as well as to discuss the prospective treatment and surveillance plan.

Third, screening: a risk profile is established for each patient or family based upon the treatment summary and administration of validated patient-reported outcome measures (PROMs). Screening PROMs include measures of patient symptom burden and quality of life (QoL), parent distress and QoL, and family psychosocial risk and functioning (refer to Table 2 for complete list). These measures are completed by the parent caregiver and patients aged >8 years at preintervention baseline (screening) to inform the first telehealth session, with selected measures repeated before the second telehealth session (monitoring).

Fourth, psychoeducation or resource provision: psychoeducation and counseling will be provided directly by the EMERGE advanced practice nurse and psychosocial clinician during the 2 scheduled telehealth sessions. Telehealth sessions will occur at least 3 months apart for families with a minimum of 2 consultations. Information resources will be provided both electronically and in hard copy if required and will directly address concerns identified in each of the EMERGE telehealth sessions (eg, immunization schedule, sleep, when to call the hospital, fatigue, financial resources, and cancer charities).

Fifth, documentation: a summary letter, personally addressed to the parent and, if applicable, adolescent, will be provided both electronically and in hard copy to families after each EMERGE consultation, along with the treatment summary, roadmap, and information resources. With parent permission, these documents will also be shared with the child’s general practitioner or pediatrician. Documents will also be sent to the primary oncologist and uploaded into the patient’s electronic medical record.

Sixth, monitoring and review: follow-up surveys after completion of the first EMERGE consultations will evaluate satisfaction with the consultation, parent stress, and information needs. PROMs are readministered before the second EMERGE consultation to enable monitoring of patient and family well-being. Goal or intervention adherence, health service usage, and referral needs will be monitored and discussed in the second EMERGE consultation. Families will be provided access to EMERGE clinicians via a dedicated email and telephone number, which will be monitored regularly by the research team.

Finally, specialist intervention: for patients and families with significant risk factors and identified concerns, referrals will be actioned to hospital or community-based specialists (eg, clinical psychology, consultant pediatrician, neuropsychology, occupational therapy, education liaison, and medical oncologist). Patients and families will also be able to escalate their concerns to activate an additional telehealth or face-to-face session with their EMERGE clinicians or specialist medical consultants as required.

Table 3 summarizes the implementation measures mapped according to the RE-AIM framework. These measures evaluate implementation processes and any factors (barriers and enablers) influencing implementation of the EMERGE model of care.

Consistent data from many research studies highlight that the end-of-treatment period is a difficult transition period for many patients and families [1,2]. Furthermore, survivors of childhood cancer are often impacted by disease and treatment-related late effects, but few interventions have been developed that adopt a preventative approach to identifying issues and proactively providing strategies and resources to optimize child and family well-being [6,62,63]. This protocol details a type 2 nonrandomized hybrid implementation-effectiveness trial that will evaluate an eHealth, multidisciplinary end-of-treatment model of care for pediatric patients who have completed treatment for ALL and their families. The EMERGE intervention addresses a critical gap in models of care at this very early survivorship period and bridges the gap between active treatment and later survivorship models.

The study will assess implementation outcomes using both quantitative and qualitative measures that will provide a detailed assessment of the feasibility and acceptability of the EMERGE model as well as barriers and facilitators. The hybrid methodology, examining implementation and effectiveness outcomes, will provide important data to guide future research and clinical efforts, given the current dearth of end-of-treatment interventions. Health economic analyses will also ascertain the relative costs of the program and contribute to efforts to achieve sustainability of such models of care into the clinical setting.

A significant strength of the EMERGE model is that it is delivered by multidisciplinary staff (advanced practice nurse and psychosocial clinician) who are able to respond to medical and psychosocial issues in real time and with the requisite expertise. This is an important feature of the EMERGE model, given the predominance of psychosocial or mental health issues reported by families during this period [3,64]. A further strength of the study is the focus on implementation outcomes, which, given the small number of published evidence-based models of care, will significantly contribute to understanding the barriers and facilitators to establishing end-of-treatment programs. The delivery of the program across 2 hospital sites will provide additional information related to contextual and organizational factors that may influence implementation. Delivery of the program via telehealth will enhance the accessibility of the program to families [39]. This is an important consideration, particularly in the Australian context, where the population is geographically dispersed and traveling to the hospital for additional visits is costly and difficult for many families [65]. We anticipate that the use of telehealth, and also additional resources to support the participation of culturally and linguistically diverse families, will potentially increase the equity and accessibility of the program for all families, and essential considerations in designing any new model of clinical care.

Limitations of the study must be noted. As the study is focused only on patients with ALL and their families, findings will not necessarily be able to translate to other diagnoses. Furthermore, despite the convenience of the telehealth model, this may also be less optimal in terms of engaging young children and adolescents, and some families may indicate a preference for in-person consultations. Finally, the nonrandomized study design means the clinical effectiveness outcomes should be interpreted with caution. The within-subject, pre-post design for clinical measures (parents’ stress and information needs) cannot exclude natural recovery or regression to the mean. Future study design considerations should consider ethical and innovative study designs, including randomized controlled designs, to measure whether interventions such as EMERGE prevent or impact short- and longer-term survivorship outcomes for young people and their families.

Addressing the complex needs of a growing population of pediatric cancer survivors is a challenge for health care systems. The EMERGE intervention offers a potentially effective and low-cost approach to addressing the unmet informational, clinical, and psychosocial needs of young survivors of ALL and their families. Importantly, the model also fosters families’ re-engagement with primary care providers (eg, general practitioners), which is an important factor in optimizing patient and family well-being as hospital resources are reduced following active treatment. The focus of this study on implementation barriers and facilitators and cost analysis will provide important information to oncology staff and hospital administrators who must continue to promote the evolution of health care models to address the significant treatment-related morbidity associated with increased pediatric cancer survivorship.