IMPACT: IMplementation of Physical Activity for Children and Adolescents on Treatment
- Conditions
- Pediatric CancerPediatric Hematology
- Interventions
- Behavioral: Physical Activity
- Registration Number
- NCT04956133
- Lead Sponsor
- University of Calgary
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Physical activity Physical Activity Participants will be offered online, individualized physical activity sessions 2-3 times/week for 15-45 minutes/session for 8-12 weeks.
- Primary Outcome Measures
Name Time Method Reach Through study completion, an average of 6 years. The number of people who participate, and reasons why or why not.
- Secondary Outcome Measures
Name Time Method Time to Implement and Deliver Through study completion, an average of 6 years. Time and expertise to deliver the intervention and physical assessments will be tracked.
Attendance Through study completion, an average of 6 years. Number of sessions attended out of the number of sessions offered by study staff.
Adherence Through study completion, an average of 6 years. Number of assessments completed out of number of scheduled assessments.
Self-Reported Physical Activity Behaviour Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) 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.
Directly Assessed Physical Activity Behaviour Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) 7-day wear period (minimum) with an activity monitor. Higher numbers indicate greater time spent in physical activity and intensity.
Functional Mobility Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) 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).
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) 30-second sit to stand test (more sit/stands indicates greater lower extremity endurance).
Balance Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) Flamingo balance test (longer time without falling, reaching, shuffling/jumping indicates better balance).
Range of Motion Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) Shoulder range of motion (ROM; greater number indicates greater ROM).
Flexibility Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) sit and reach flexibility (greater distance indicates higher flexibility).
Aerobic Capacity Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) Aerobic step tests (more steps indicates higher aerobic capacity).
Cancer-Specific 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) PedsQL 3.0 Cancer Module (Varni et al., 2009). Score range 0-100; higher scores indicate better quality of life.
Health-Related 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) PedsQL 4.0 Generic Core Scales (Varni et al., 2009). Score range 0-100; higher scores indicate better quality of life.
Symptoms Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) 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.
Cognitive Functioning Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) 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.
Maintenance of Physical Activity Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52) Number of participants who maintain physical activity following the program.
Physical Activity Fidelity Through study completion, an average of 6 years. Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of sessions.
Adverse Events Through study completion, an average of 6 years. Adverse events will be defined as any negative effect caused (or suspected to be caused by) the physical activity program.
Healthcare Provider and Staff Uptake Through study completion, an average of 6 years. Healthcare providers' and clinical staffs' referral to the physical activity program
Trial Locations
- Locations (2)
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada