IMplementation of Physical Activity for Children and adolescents on Treatment (IMPACT) for Cancer Diagnoses in Alberta: Protocol for a Single-Arm, Mixed-Methods, Hybrid Effectiveness-Implementation Trial.
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BACKGROUND: Physical activity (PA) is feasible, safe, beneficial, and recommended for pediatric patients with cancer. Nevertheless, PA levels remain low due to treatment-related effects (eg, fatigue, pain), isolation and immunosuppression, geographic and transportation barriers, and limited access to population-specific programming. Delivering PA by videoconference may address some of these barriers. Thus, IMplementation of Physical Activity for Children and adolescents on Treatment (IMPACT) was developed. IMPACT is an individualized, tailored PA intervention delivered by an exercise professional over videoconference and is being evaluated in a hybrid effectiveness-implementation trial. OBJECTIVE: The objectives of this trial include (1) assessing the effectiveness of IMPACT on participants' device-measured PA (primary effectiveness outcome) and secondary effectiveness outcomes, including participant- and caregiver-reported PA and participant- and caregiver-reported quality of life, symptoms, cognitive function, resource use, and participant physical fitness outcomes (ie, participants' aerobic endurance, lower body flexibility, shoulder flexion range of motion, balance, functional mobility); and (2) assessing the implementation of IMPACT and the trial through evaluating recruitment, indices of feasibility, delivery time, expertise, cost, fidelity of intervention delivery, and adverse events. METHODS: A single-arm, mixed-methods, type II hybrid effectiveness-implementation trial is being conducted, and the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework is guiding evaluation. Pediatric patients with cancer and blood disorders diagnosed between 5 and 18 years of age are being recruited in Alberta. Following informed consent/assent and baseline assessments (ie, participants' device-measured PA, participant- and caregiver-reported outcomes, participant physical fitness outcomes), participants receive individualized, tailored PA sessions up to 3 times/week for 15-45 minutes/session over 12 weeks from an exercise professional via videoconference. Assessments are then completed postintervention (with the addition of a participant and caregiver interview) and at 6- and 12-month follow-ups. With respect to RE-AIM, reach covers referral and participation rates, participants' and caregivers' personal and medical information, and the proportion of participants from rural versus urban locations. Effectiveness includes participants' device-measured PA, participant- and caregiver-reported outcomes, and participant physical fitness outcomes. Adoption covers sources of referral. Implementation includes recruitment, feasibility, delivery time, expertise, cost, fidelity of intervention delivery, and adverse events. Maintenance includes participants' and caregivers' desire for ongoing access to PA, and participant- and caregiver-reported PA levels at 6- and 12-month follow-ups. Throughout the trial, quality improvement cycles occur every 6 months. RESULTS: Funding was obtained in April 2022. Participant recruitment began in March 2022 and will conclude in December 2025. Interim analyses and additional analyses of selected trial data have been conducted, and publications are forthcoming. Full trial results will be analyzed and published following trial cessation. CONCLUSIONS: This work will provide insights into the effects of, and factors influencing, the implementation of an individualized, tailored PA intervention delivered by videoconference. Findings may support continued exploration of videoconference delivery as a strategy to ensure that more pediatric patients can access and benefit from PA. TRIAL REGISTRATION: ClinicalTrials.gov NCT04956133; https://clinicaltrials.gov/ct2/show/NCT04956133. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59302.