IMPACT: IMplementation of Physical Activity for Children and Adolescents on Treatment

Study Overview
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Brief Summary
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Physical activity can enhance well-being among youth diagnosed with oncological or hematological diseases. We developed a tailored, 1:1, online physical activity program (i.e., IMPACT), to promote physical activity in this cohort. The proposed single-group, mixed-methods project will assess the effect of IMPACT and explore markers of implementation.

Official Title
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Effectiveness and Implementation of Physical Activity for Children and Adolescents on Treatment for Cancer and/or Blood Diseases

Conditions
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Pediatric Cancer, Pediatric Hematology

Intervention / Treatment
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* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children or adolescents between the ages of 5-18 years at enrollment and at least one parent (defined as a caregiver; biological or otherwise) Diagnosed with any oncological and/or hematological diagnosis Currently receiving or scheduled to receive any treatment for any oncological and/or hematological diagnosis or completed treatment <3 months Exclusion Criteria: Completed all treatment for their oncological or hematological diagnosis >3 months Unable to participate in physical activity as assessed by the patients' healthcare team or physical activity specialist Parent and/or patient cannot understand verbal English Parent is unwilling to be present (i.e., at home, in the same room depending on participant age and functional ability) during the physical activity sessions (required to ensure safety of the child/adolescent)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity<br>Participants will be offered online, individualized physical activity sessions 2-3 times/week for 15-45 minutes/session for 8-12 weeks. | Behavioral: Physical Activity<br>* Participants will receive the IMPACT program, which includes a combination of aerobic, resistance, balance, and flexibility exercises conducted 1:1 and delivered online by a physical activity specialist via Zoom. The IMPACT program follows basic physical activity progression principles (i.e., principles of frequency, intensity, time, type, overload and progression). Tailoring will be used to promote fitness and wellness benefits, while ensuring safety. In addition, prominent behaviour change techniques will be provided by physical activity specialists within each 1:1 session. Discussions and worksheets will be provided, depending on participants needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach | The number of people who participate, and reasons why or why not. | Through study completion, an average of 6 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance | Number of sessions attended out of the number of sessions offered by study staff. | Through study completion, an average of 6 years. | 
| Adherence | Number of assessments completed out of number of scheduled assessments. | Through study completion, an average of 6 years. | 
| Self-Reported Physical Activity Behaviour | Modified Leisure Time Exercise Questionnaire (Godin & Shephard, 1985). Time spent in mild, moderate, and vigorous activity will be calculated. Higher numbers indicate greater physical activity. | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Directly Assessed Physical Activity Behaviour | 7-day wear period (minimum) with an activity monitor. Higher numbers indicate greater time spent in physical activity and intensity. | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Functional Mobility | The timed up and go test (shorter time indicates better functional mobility). Note, this and other physical tests to follow were selected based on use with healthy children, children with chronic conditions, and adults with and without chronic conditions (e.g., Bohannon, 1995; Canadian Society of Exercise Physiology, 2019; Deforche et al., 2003; Haas et al., 2017; Jankowski et al., 2015; Kolber & Hanney, 2012; Lemmink et al., 2003; McNeely et al., 2019; Muir et al., 2010; Podsiadlo & Richardson, 1991; Thorsteinsson et al., 2013). | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Lower Extremity Endurance | 30-second sit to stand test (more sit/stands indicates greater lower extremity endurance). | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Balance | Flamingo balance test (longer time without falling, reaching, shuffling/jumping indicates better balance). | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Range of Motion | Shoulder range of motion (ROM; greater number indicates greater ROM). | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Flexibility | sit and reach flexibility (greater distance indicates higher flexibility). | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Aerobic Capacity | Aerobic step tests (more steps indicates higher aerobic capacity). | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Cancer-Specific Quality of Life | PedsQL 3.0 Cancer Module (Varni et al., 2009). Score range 0-100; higher scores indicate better quality of life. | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Health-Related Quality of Life | PedsQL 4.0 Generic Core Scales (Varni et al., 2009). Score range 0-100; higher scores indicate better quality of life. | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Symptoms | Symptom Screening in Pediatrics Tool (Hyslop et al., 2018). Score range 0-60; higher score indicates more symptoms experienced and greater severity of symptoms experienced. | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Cognitive Functioning | Behavior Rating Inventory of Executive Function 2nd Ed (Gioia et al., 2015). Frequency of behaviors are ranked from Never to Often, and results are reported as t scores where higher scores indicate greater deficits. | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Maintenance of Physical Activity | Number of participants who maintain physical activity following the program. | Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) | 
| Physical Activity Fidelity | Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of sessions. | Through study completion, an average of 6 years. | 
| Time to Implement and Deliver | Time and expertise to deliver the intervention and physical assessments will be tracked. | Through study completion, an average of 6 years. | 
| Adverse Events | Adverse events will be defined as any negative effect caused (or suspected to be caused by) the physical activity program. | Through study completion, an average of 6 years. | 
| Healthcare Provider and Staff Uptake | Healthcare providers' and clinical staffs' referral to the physical activity program | Through study completion, an average of 6 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematology, Childhood cancer, Adolescent cancer, In-patient, Out-patient, Oncology