A protocol for a single-arm, mixed methods, hybrid effectiveness-implementation trial evaluating the IMplementation of Physical Activity for Children and adolescents on Treatment (IMPACT) for cancer diagnoses in Alberta

Background: Physical activity (PA) is feasible, safe, beneficial, and recommended for pediatric cancer patients, yet PA levels are low due to numerous barriers. Delivering PA by videoconference may address selected barriers. Few have explored this delivery modality; in response the IMplementation of Physical Activity for Children and adolescents on Treatment (IMPACT) intervention (a PA intervention) was developed. Methods: : The IMPACT intervention is delivered by videoconference and is being evaluated in a single-arm, mixed methods, type II hybrid effectiveness-implementation trial. Pediatric cancer and blood disorder patients diagnosed between 5-18 years old are eligible. Participants are offered tailored PA sessions 3 times/week for 15-45 minutes/session over 12-weeks. The co-primary aims of this trial are to: (1) assess the effectiveness of the videoconference-delivered PA intervention on participant’s objective PA (primary effectiveness outcome) and secondary effectiveness outcomes of participant- and caregiver-reported outcomes, and physical fitness outcomes at baseline, post-intervention, and 6 and 12-month follow-ups, and (2) assess implementation of the PA intervention and trial through evaluating recruitment, indices of feasibility, delivery time, expertise, cost, fidelity of intervention delivery, and adverse events. Interviews are conducted post-intervention with participants and caregivers to explore perceptions of and experiences with the intervention. Implementation data are tracked throughout and quality improvement cycles occur every 6 months. Trial data are analyzed at pre-specified time-points. Conclusions: : This work will provide insights into the effects and factors influencing PA intervention implementation. Findings may offer support for videoconference delivery as a strategy to ensure more pediatric patients can access and benefit from PA.