Clinical trial NCT04956133: IMPACT: IMplementation of Physical Activity for Children and Adolescents on Treatment
Official title: Effectiveness and Implementation of Physical Activity for Children and Adolescents on Treatment for Cancer and/or Blood Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Pediatric Hematology
Keywords: Childhood cancer
Adolescent cancer
In-patient
Out-patient
Oncology
Hematology
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital
name: Stollery Children's Hospital
name: Canadian Cancer Society (CCS)
name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-07-09
Enrollment: 250
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Children or adolescents between the ages of 5-18 years at enrollment and at least one parent (defined as a caregiver; biological or otherwise)
2. Diagnosed with any oncological and/or hematological diagnosis
3. Currently receiving or scheduled to receive any treatment for any oncological and/or hematological diagnosis or completed treatment \<3 months

Exclusion Criteria:

1. Completed all treatment for their oncological or hematological diagnosis \>3 months
2. Unable to participate in physical activity as assessed by the patients' healthcare team or physical activity specialist
3. Parent and/or patient cannot understand verbal English
4. 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)

Primary outcomes:
measure: Reach
timeFrame: Through study completion, an average of 6 years.
Secondary outcomes:
measure: Attendance
timeFrame: Through study completion, an average of 6 years.
measure: Adherence
timeFrame: Through study completion, an average of 6 years.
measure: Self-Reported Physical Activity Behaviour
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Directly Assessed Physical Activity Behaviour
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Functional Mobility
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Lower Extremity Endurance
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Balance
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Range of Motion
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Flexibility
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Aerobic Capacity
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Cancer-Specific Quality of Life
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Health-Related Quality of Life
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Symptoms
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Cognitive Functioning
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Maintenance of Physical Activity
timeFrame: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
measure: Physical Activity Fidelity
timeFrame: Through study completion, an average of 6 years.
measure: Time to Implement and Deliver
timeFrame: Through study completion, an average of 6 years.
measure: Adverse Events
timeFrame: Through study completion, an average of 6 years.
measure: Healthcare Provider and Staff Uptake
timeFrame: Through study completion, an average of 6 years.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
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