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Clinical Trials/NCT04956133
NCT04956133RecruitingNot Applicable

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

University of Calgary2 sites in 1 country250 target enrollmentStarted: August 3, 2022Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
250
Locations
2
Primary Endpoint
Reach
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
5 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Physical activity

Experimental

Participants will be offered online, individualized physical activity sessions 2-3 times/week for 15-45 minutes/session for 8-12 weeks.

Intervention: Physical Activity (Behavioral)

Outcomes

Primary Outcomes

Reach

Time Frame: Through study completion, an average of 6 years.

The number of people who participate, and reasons why or why not.

Secondary Outcomes

  • Physical Activity Fidelity(Through study completion, an average of 6 years.)
  • Adverse Events(Through study completion, an average of 6 years.)
  • Healthcare Provider and Staff Uptake(Through study completion, an average of 6 years.)
  • Time to Implement and Deliver(Through study completion, an average of 6 years.)
  • Attendance(Through study completion, an average of 6 years.)
  • Adherence(Through study completion, an average of 6 years.)
  • 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))
  • 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))
  • Functional Mobility(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(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
  • 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(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
  • 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(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(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(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
  • Symptoms(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
  • Cognitive Functioning(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(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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