An interim analysis of the ongoing type II hybrid effectiveness–implementation trial evaluating IMPACT was conducted. Ethics approval for the full trial was granted from the Research Ethics Boards at the University of Calgary (HREBA.CC-20-0364) and the University of the Fraser Valley (HREB-101287), and administrative approvals were obtained from the children's hospitals in Alberta (the Alberta Children's Hospital and the Stollery Children's Hospital). A detailed overview of all aspects of the PA intervention (IMPACT) and trial has been published (22) and is available at the clinical trials registration (accessed on 19 June 2025). Only methods and analyses pertinent to this interim report are provided herein. Reporting follows guidance from the Consolidated Standards of Reporting Trials (CONSORTs) for eHealth interventions (25) and the Standard for Reporting Implementation Studies (StaRI) statement (26) (see Supplementary File 1).

Potential participants are recruited through referral from healthcare providers at the Alberta Children's Hospital or the Stollery Children's Hospital via consent to contact forms, posters, and self-referral documents, emails from a local support organization (i.e., Kids Cancer Care Foundation of Alberta), and word of mouth.

Eligibility criteria include the following: (1) being a child or adolescent between the ages of 5–18 years at enrollment, (2) having been diagnosed with any cancer or blood disorder, (3) scheduled to receive, currently receiving, or recently completed treatment <3 months ago, (4) being medically cleared to participate in PA, (5) having a caregiver willing to complete assessments and be present during PA sessions, and (6) having capacity to provide informed consent and understand intervention and trial information in English. Of note, the decision to include pediatric blood disorder patients was made considering that pediatric cancer and blood disorder patients are typically treated on the same unit/ward, the supervised, tailored, and low-risk nature of the PA delivered in IMPACT, early available evidence suggesting safety and benefits of PA in this cohort (1–9), and consultations with trial team members who supported including pediatric blood disorder patients).

Interested and eligible participants and their caregivers are sent a link to online consent/assent forms by a member of the trial team via Research Electronic Capture [REDCap; a secure, online, data-capture system (27, 28)]. Participants complete informed consent or assent (as appropriate; see below) and caregivers provide informed consent for themselves (and where required, provide informed consent on behalf of their child). Of note, guidance from Alberta Health Services is being followed to determine whether or not a participant is considered a mature minor, accessed on 19 June 2025; minors typically 14 years and older who can understand and appreciate the nature, risks, and consequence of participating in proposed procedures and who are able to provide consent without the input of their legal guardian. If determined to be a mature minor, the participant provides consent for themself. If determined not to be a mature minor, the participant provides assent for themselves and caregivers complete parental informed consent on behalf of their child.

Briefly, the PA intervention (IMPACT) is comprised of tailored PA sessions that are delivered 1:1 by an exercise professional by videoconference (i.e., Zoom) up to 3 times/week for 15–45 min/session, over 12 weeks. Exercise professionals who deliver have completed a comprehensive training, including educational, practical, and trial-specific training [full training details published elsewhere (29)]. Sessions include a combination of aerobic, resistance, balance, core, and flexibility exercises following a detailed protocol. As such, the intervention aligns with the American College of Sports Medicine (ACSM) and Exercise and Sport Science Australia (ESSA) consensus statement on PA and exercise terminology (30), the term PA is used throughout to enhance inclusivity and accessibility. All components (i.e., frequency, intensity, time, and type) are tailored for each participant based on their needs, preferences, and abilities, including how they are feeling and managing treatment-related side-effects, their treatment schedules, and any other considerations (i.e., other commitments). Finally, PA sessions are augmented with behaviour change support via discussion of pertinent and individualized topics (i.e., goal setting, feedback and monitoring, social support, and self-monitoring).

Given PA delivery is by videoconference, several precautions are taken to enhance safety, including obtaining medical clearance for participants and collecting pertinent personal and medical information and consulting with participants and their caregivers, the participants’ healthcare team, and an exercise professional with >20 years of experience in delivering PA for this population to support tailoring PA sessions. Additionally, a detailed protocol (that takes into account the necessity of tailoring) was developed to support safe PA delivery, detailed emergency protocols are available, and caregivers are required to be present during PA sessions (either in the same room or home as the child; depending on age/preferences). With regards to assessments of physical function (see Effectiveness below), similar safety precautions are employed.

The RE-AIM framework [reach, effectiveness, adoption, implementation, and maintenance; (23, 24)] is guiding evaluation for the trial and this interim analysis. Specifically, selected data related to reach, effectiveness, adoption, and implementation are reported herein. Data for reach, adoption, and implementation are collected throughout the trial. Effectiveness data are collected at baseline (week 0) and post-intervention (week 12). Data pertaining to quality improvement cycles are collected throughout the trial and are reviewed every 6 months.

An advisory board was formally created 12 months into the trial on 25 August 2023 to address the noted limitation of not having patient or caregiver perspectives included in the development of the IMPACT intervention and trial. Currently, the advisory board is comprised of one past participant (of note, initially two past participants comprised the board, however, one passed away), two caregivers, one healthcare provider, one community partner, and four trial team members (including the two co-principal investigators and two coordinators). The advisory board meets quarterly by videoconference to discuss data collected for quality improvement (see quality improvement cycles above), to provide advice regarding potential challenges, gaps, and opportunities within the PA intervention and trial implementation, and dissemination of findings. Meetings last 30–60 min. To date, advisory board members have contributed to outputs including news releases [i.e., University of Calgary UToday Article¹ (accessed on 19 June 2025), Global News² (accessed on 19 June 2025) interview], poster and oral presentations at local, national, and international conferences, and a peer-reviewed publication (22).

No sample size was computed given interim report objectives to report data to date and given impending trial cessation. Of note, the sample size estimation for the full trial was set to 76 for primary effectiveness outcomes of PA, and further details are available at the clinical trials registration³ (accessed on 19 June 2025) and published protocol (22).

Data covering reach, adoption, and implementation were managed and analyzed in Microsoft Excel version 16.77.1. First, descriptive statistics [i.e., means, standard deviations (SD), numbers, and percentages] were computed to describe data on referral and participation rates, personal and medical information of participants and caregivers, the number and type of healthcare providers who referred between the two sites, trial retention, adherence to PA sessions, percentage of missing data, intervention delivery time and expertise, PA session fidelity, measures of trial delivery time, adverse events, and quality improvement cycles meetings.

With regards to data covering select secondary effectiveness outcomes, the initial intent for this interim analysis was to explore changes from baseline (week 0) to post-intervention (week 12) via Wilcoxon signed-rank tests and report within-group effect sizes. However, given the smaller-than-anticipated sample size and 54% missing data, which was missing not at random (40), the decision was made to modify the data analysis plan and conduct case-by-case analysis and compute individual change scores for participant-reported outcomes of quality of life and assessments of physical function. This aligns with guidance for studies with small sample sizes and high amounts of missing data (41, 42).Finally, quality improvement cycle data for 6 cycles included descriptive data from participants' personal and medical information (analyzed via descriptive statistics as described above) and semi-structured interviews with healthcare providers and exercise professionals (which were briefly read, not analyzed). These data were collated, reviewed, and discussed amongst the trial team. Following trial team review and reflection, advisory board members reviewed and addressed key questions and issues prepared by the trial team. Through discussion and (re-)review of the summarized data, decisions were mutually agreed upon about the development of additional resources to support implementation. Once resources were identified as needed, the trial team led the development of the resources and shared them with the advisory board for input/edits. Herein, the focus of results is on the outputs (i.e., refinements made to date) from the quality improvement cycles. Of note, all refinements have been carefully considered and made only as related to recruitment, supporting exercise professionals conducting assessments of physical function and delivering PA sessions, and not other aspects of the intervention or trial that could influence effectiveness data.

Between 1 March 2022 (date of trial launch) and 12 December 2024, 93 patients were referred (healthcare provider referral; n = 84; 90%) or self-referred (n = 9; 10%). Of the 93 participants who were referred, 36 (39%) scheduled a phone call with the trial team to receive more information, 22 (61%) provided informed consent, and 14 enrolled in the intervention for a 39% participation rate. Figure 1 depicts the flow of participants through the intervention and reasons for not participating. At the time of this interim analysis, 12 of the 14 (86%) patients who consented and enrolled completed the intervention, and 2 (14%) are currently in the intervention.

Of the 14 participants (9.69 ± 3.50, 5–16 years old) who consented and enrolled, 6 (43%) identified as female. Participants were of varying ethnicities, with most identifying as South Asian (n = 7; 50%), Southeast Asian (n = 4; 29%), and White—North American (n = 3; 21%). Twelve (86%) participants had cancer, of which varied diagnoses were reported, though acute lymphoblastic leukemia was most commonly reported (n = 7; 50%). Two participants were diagnosed with a blood disorder (aplastic anemia; n = 2; 14%). Participants were diagnosed with their cancer or blood disorder between 2020 and 2024, and all (100%) were on treatment. Three (21%) participants were treated at the Alberta Children's Hospital, and eleven (79%) were treated at the Stollery Children's Hospital. Table 1 provides further participant details. As mentioned above, two participants are currently completing the intervention.

Table 2 includes individual change scores for the 12 participants who completed the intervention on outcomes of quality of life and scores on measures assessing aerobic endurance, lower body flexibility, shoulder flexion range of motion, balance, and functional mobility. Complete participant-reported outcome data (i.e., quality of life) were available at baseline for all (n = 12; 100%), and scores for quality of life ranged from low to moderate. At post-intervention (week 12), only four (33%) completed participant-reported outcomes, and quality of life scores also ranged from low to high. Looking at those with complete data, general quality of life increased for all, and cancer-specific quality of life increased for one, stayed the same for one, and decreased for two.

Complete physical function outcome data (i.e., aerobic endurance, lower body flexibility, shoulder flexion range of motion, balance, and functional mobility) were available for 11 (92%) at baseline and scores ranged from low to moderate on aerobic endurance, low for lower body flexibility, mild restriction to normal shoulder flexion range of motion, low to high on balance, and low to high on functional mobility. At post-intervention (week 12), only seven (58%) participants completed assessments of physical function. Again, scores ranged from low to moderate on aerobic endurance, low for lower body flexibility, mild restriction to normal shoulder flexion range of motion, low to high on balance, and low to high on functional mobility. Looking at those with complete data, aerobic endurance (2 min step test) improved for three and worsened for four. Lower body flexibility right side (sit and reach test) improved for two and worsened for four, whereas lower body flexibility left side improved for one and worsened for five. Shoulder range of motion right side (shoulder flexion test) improved for five and worsened for two, and shoulder range of motion left side improved for three and worsened for four. Right side balance (flamingo balance test) improved for four, stayed the same for one, and worsened for two, whereas left side balance improved for two, stayed the same for one, and worsened for four. Functional mobility via the 30 s sit-to-stand test improved for four and worsened for two, and the timed up and go test improved for three and worsened for three.

Eighty-four healthcare provider referrals were made, which were distributed relatively even between the Alberta Children's Hospital (n = 35; 42%) and the Stollery Children's Hospital (n = 49; 58%). Potential participants who self-referred indicated hearing about the intervention and trial from a cancer support organization (Kids Cancer Care Foundation of Alberta; n = 3; 33%) and posters at hospitals (n = 6; 67%). Of the 14 participants who consented and enrolled, all (100%) had also heard about the intervention and trial from healthcare providers, specifically from participants' physical therapists (n = 9; 64%), oncologists (n = 4; 29%), and nurses (n = 2; 14%). All participants from Alberta Children's Hospital (n = 3; 100%) were referred by a pediatric oncologist and 9 (82%) from Stollery were referred by a physical therapist, and the remaining were referred by a nurse (n = 2; 18%) and pediatric oncologist (n = 1; 9%).

Of the 14 participants who consented and enrolled, all (100%) completed baseline assessments of participant-reported outcomes of quality of life and physical function. Of the 12 participants who completed the intervention, 4 (33%) completed participant-reported outcomes, and 7 (58%) completed assessments of physical function, resulting in 33% retention in the trial. Reasons for not completing participant-reported outcomes (n = 8) included not feeling well (n = 5; 63%), other conflicts (n = 2; 25%), and lost to follow-up (n = 1; 13%). Reasons for not completing assessments of physical function (n = 5) included not feeling well (n = 3; 60%) and other conflicts (n = 2; 40%). Missing data for participant-reported outcomes of quality of life and assessments of physical function were 54%. Of the three PA sessions that were offered to each participant per week, on average, 2 ± 1 sessions (range = 0–3 sessions) were completed each week, resulting in 57% adherence to PA sessions.

For the 12 participants who completed the intervention, intervention delivery and administrative time to date have been >300 h. Across baseline and post-intervention assessments of physical function, 19 (of a possible 24) were conducted, totalling 9.5 h of assessments. Six trained assessors have been involved in conducting these 19 assessments: four graduate students served as primary assessors (i.e., leading the assessments of physical function by talking and demonstrating the various assessments), while six graduate and undergraduate students served as secondary assessors (i.e., supporting the primary assessor by counting and timing). In terms of expertise, all assessors had prior experience conducting assessments of physical function for young adults and/or adults affected by cancer, both in-person and delivered by videoconference (43–45). With regards to training, all assessors completed the Thrive Health Cancer and Exercise training⁴ (accessed on 19 June 2025) and have experience conducting similar videoconference-based assessments with young adults and adults living with and beyond cancer (43–45). Additionally, all assessors received IMPACT-specific training, which included a 30 min review of the assessments with one of the trial coordinators.

Across the 12 participants who completed the intervention, a total of 200 PA sessions have been delivered, totalling >115 delivery hours. These sessions were led by one of three exercise professionals (graduate students) who have expertise and experience in delivering PA classes delivered by videoconference for adults affected by cancer (43, 44). Regarding training, all exercise professionals completed a comprehensive >30 h educational [i.e., Thrive Health Cancer and Exercise training (see text footnote 4) (accessed on 19 June 2025) as well as the pediatric cancer and exercise⁵ (accessed on 19 June 2025) and adolescent and young adult⁶ (accessed on 19 June 2025) specific modules], practical application (i.e., scenario-based competency training session, shadowed an existing group-based PA program in the community [i.e., PEER,⁷ accessed on 19 June 2025; (46)], and trial-specific training (e.g., oncology treatment and side-effects, modifying PA based on treatment-related side-effects, supporting movement, intervention processes).

Trial coordination has been managed by two trial members (a PhD candidate and a staff research administrator), who have collectively worked 215 h. Their responsibilities include outreach (e.g., emails to healthcare providers and cancer support organizations, updating recruitment materials, and scheduling presentations), liaising with healthcare providers, receiving consent to contact forms, communicating with participants and caregivers, administering consent (and assent as appropriate), distributing participant-reported outcome questionnaires, scheduling participants' assessments of physical function, coordinating the primary and secondary assessors, and connecting participants with the exercise professional. Coordinators oversee the training and onboarding of other trial staff, including exercise professionals, primary and secondary assessors, and research assistants.

A fidelity audit was conducted on a random sample of 10% of PA sessions for each participant, with two trial team members completing a 19-item standardized checklist. Fidelity was high (95.2% ± 3.83; 88.9%–100%), and indicated that exercise professionals appropriately welcomed participants, tailored exercises safely and effectively based on participants' needs, energy, preferences, and abilities, and incorporated various behaviour change techniques (e.g., goal setting and self-monitoring) throughout the PA sessions to further support participants. No adverse events were reported by participants, caregivers, or exercise professionals.

From March 2022 to December 2024, six quality improvement cycles have occurred, three of which included the advisory board. During quality improvement cycle meetings, whether with trial staff only (March 2022 to March 2023) or trial staff and advisory board members (September 2023 to present), collated data identified issues between the number of referrals and the number of participants and caregivers consenting and enrolling. In an effort to support consenting, additional resources (e.g., posters, brochures, a frequently asked questions document; see Supplementary File 2) were iteratively developed and three short (2–3 min) videos were developed to inform potential participants (patients) and caregivers about the IMPACT intervention and trial and the assessments of physical function (see Supplementary File 2). Additional issues were noted with the number of referrals and the need to enhance the number of referring healthcare providers. Thus, four outreach presentations were conducted by the trial team at both hospitals to increase healthcare provider awareness about IMPACT. Finally, issues were noted with regard to assessment completion (see missing data above). Discussions with the advisory board suggested a need for greater scheduling flexibility (i.e., times during the day and evening) for assessments of physical function and PA sessions and scheduling auto-reminders. In response, two additional assessors were trained since the onset of this study to offer greater scheduling flexibility, especially in the evening.