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

Sponsor
University of Calgary (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04956133
Collaborator
Alberta Children's Hospital (Other), Stollery Children's Hospital (Other), Canadian Cancer Society (CCS) (Other), Canadian Institutes of Health Research (CIHR) (Other)
250
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69.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physical Activity
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effectiveness and Implementation of Physical Activity for Children and Adolescents on Treatment for Cancer and/or Blood Diseases
Anticipated Study Start Date :
Aug 3, 2022
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Jun 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physical activity

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
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.

Outcome Measures

Primary Outcome Measures

  1. Reach [Through study completion, an average of 6 years.]

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

Secondary Outcome Measures

  1. Attendance [Through study completion, an average of 6 years.]

    Number of sessions attended out of the number of sessions offered by study staff.

  2. Adherence [Through study completion, an average of 6 years.]

    Number of assessments completed out of number of scheduled assessments.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. Healthcare Provider and Staff Uptake [Through study completion, an average of 6 years.]

    Healthcare providers' and clinical staffs' referral to the physical activity program

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Calgary
  • Alberta Children's Hospital
  • Stollery Children's Hospital
  • Canadian Cancer Society (CCS)
  • Canadian Institutes of Health Research (CIHR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Calgary
ClinicalTrials.gov Identifier:
NCT04956133
Other Study ID Numbers:
  • HREBA.CC-20-0364
First Posted:
Jul 9, 2021
Last Update Posted:
Feb 21, 2022
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Calgary

Study Results

No Results Posted as of Feb 21, 2022