A digital health education program promoting physical activity for childhood cancer survivors: A hybrid effectiveness-implementation trial of 'Making Moves'

Brief Name: A digital health education program promoting physical activity for childhood cancer survivors: A hybrid effectiveness-implementation trial of 'Making Moves'. Physical or informational materials that will be used in the intervention: This program involves online telehealth consultations with an Accredited Exercise Physiologist complimented with access to a digital program including evidence-based health behaviour educational modules and guided physical activities. Each module focuses on a different topic about physical activity and health. Examples of topics covered in the modules include regular physical activity, sedentary behaviours and healthy eating. The anticipated duration of each module is approximately 10-20 minutes (not including exercise videos). The program aims to engage participants in physical activity via a range of guided home-based physical activities in the form of instructional videos. Physical activity videos range from 1-15 minutes and participants can choose how many they wish to watch/follow. Examples of videos include guided bodyweight strength exercises, stretches, and circuit exercises. Participants will be gifted with an activity tracker to support their physical activity engagement and health behaviour education. We will assess program adherence (module completion and physical activity videos) via self-report questionnaire. Each of the procedures, activities, and/or processes used: a) Up to five online consultations with an accredited exercise physiologist at pre-intervention (week 0), intervention (week 2 or 3) (optional), post-intervention (week 9), ‘booster’ session (3-months post-program completion) and follow-up (6-months post-program completion). b) Individualised goal setting c) Guided home-based physical activity videos d) Age-appropriate evidence-based health behaviour education Who will deliver the intervention: An accredited exercise physiologist, and research staff (i.e., study coordinator, research officer). Mode of delivery: Exercise physiology consultations will be delivered online via videoconference or telephone (depending on participant preference). The digital health program will be delivered via a website that can be accessed via computer, phone, or tablet. Participants will each have their own login account to access the website. The number of times the intervention will be delivered and over what period of time: The length of the intervention, including the pre-intervention and post-intervention consultations will be 10 weeks. There will be a “booster” consultation at 3-months following program completion and follow up at the 6-month period. There will be five online video consultations with an Accredited Exercise Physiologist pre-intervention at week 0, an optional consultation at week 2 or 3 of the intervention, post-intervention at week 9, 3-month booster session and at follow up 6 months following program completion. Each will be approximately 60 minutes. Each consultation will be individualised to the participant and will include exercise assessments, health behaviour education, tailored goal-setting, and discuss participant barriers and facilitators to exercise. Participants will also complete a questionnaire pack (approx. 10-15 min) at three time points (pre-intervention, post-intervention, and at 6-month follow-up). Participants will be provided access to our digital program throughout the intervention period. The program is self-guided. Participants will be encouraged to complete one module per week for eight weeks, and can follow the physical activity videos as much as they would like. Participants will be given the autonomy over what educational content they would like to access and what physical activities they would like to complete. Location where the intervention occurs: The intervention is home-based and will be distance delivered. Implementation component: As a Type 1 Hybrid Effectiveness-Implementation trial, our secondary aim is to explore the barriers and facilitators to implementation and scale-up from multiple levels (i.e., individual, provider, organisational and community) that will inform our future implementation strategies. We will conduct a process evaluation guided by two implementation frameworks: the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF). The purpose of the CFIR is to facilitate synthesis of research findings across studies and contexts. The CFIR includes 39 constructs arranged over five domains (intervention characteristics, outer setting, inner setting, process, and characteristics of individuals). The purpose of the TDF is used to promote the development of interventions to enhance implementation. The TDF includes 128 constructs in 14 domains including knowledge, skills, social/professional role and identity, beliefs about capabilities, beliefs about consequences, motivation and goals, memory, attention and decision processes, environmental context and resources, social influences, emotion, behavioural regulation, and nature of the behaviour. Our rationale for using two frameworks is because the TDF focuses on individual-level behaviour change, whilst the CFIR focuses on implementation determinants at the organisational level. When combined, these two frameworks will help to address multiple levels of behaviour change in healthcare. Therefore, we will use the CFIR to explore what works, where, and why across various contexts and we will use the TDF to identify and describe patient barriers and facilitators that can affect implementation and scale-up of the intervention. Implementation outcomes (judging the implementation success of our program) We will collect implementation data for our process evaluation throughout the intervention and at post-intervention, including: 1) Resources relating to the intervention will be recorded in an Excel spreadsheet to identify and value costs. Resources may include any distance-delivery technology used to deliver the program, program development, educational material, and activity trackers. 2) Intervention costs (costs related to the delivery and uptake of the program). The study exercise physiologist who delivers the pre-, post- and follow-up consultations will also complete a detailed log of costs throughout the intervention (e.g., cost of study equipment for each participant). 3) Changes in environmental context that may impact participant opportunities to be physically active will be recorded by study staff as potential influences of engagement in the intervention. We will additionally conduct semi-structured interviews with research staff (e.g., study exercise physiologist) to seek feedback regarding the implementation potential in their setting, adaptation needs for better fit in their context, and potential implementation strategies needed to support uptake. The study coordinator and exercise physiologist involved in delivering the intervention will also keep detailed notes throughout the intervention on any barriers and facilitators to the delivery of the program, and potential improvements or strategies that may be important for future implementors. Factors that affect implementation to inform future scale-up We will conduct TDF-guided semi-structured interviews with participants and their parents at post-intervention to explore barriers and facilitators to implementing our digital health intervention to promote physical activity self-efficacy. We will conduct CFIR-guided semi-structured interviews with healthcare professionals (e.g., nurses, exercise physiologists, and physiotherapists), and community organisations who may be involved in the future implementation of our program. Who will be involved in this component: participants and their parents, healthcare professionals, community organisations, study staff. Timing of this component relative to the intervention: Throughout the intervention period and at post-program completion.