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Pediatric CancerNCT04956133

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

A study testing Physical Activity in people with Pediatric Cancer and Pediatric Hematology, run by University of Calgary at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Pediatric Cancer, Pediatric Hematology
What is being tested?
Physical Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
2 sitesCanada
Study dates
3 Aug 2022to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

S. Nicole Culos-Reed, PhD contact

403-220-7540

nculosre@ucalgary.ca

Canada2 sites, 2 recruiting
  • Alberta Children's Hospital

    Calgary, Alberta

    Emma McLaughlin PhD Candidate, MSc, 1-403-210-8482, emma.mclaughlin1@ucalgary.ca

    Nicole Culos-Reed, PhD

    Recruiting
  • Stollery Children's Hospital

    Edmonton, Alberta

    Emma McLaughlin PhD Candidate, MSc, 1-403-210-8482, emma.mclaughlin1@ucalgary.ca

    Nicole Culos-Reed, PhD

    Recruiting

Other trials in Canada

About this study

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

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.

Being tested
Physical Activity
Keywords
Childhood cancer, Adolescent cancer, In-patient, Out-patient, Oncology, Hematology
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ActivityBehavioural

    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.

Study groups in NCT04956133
Study groupRoleWhat they receive
Physical activityExperimentalParticipants will be offered online, individualized physical activity sessions 2-3 times/week for 15-45 minutes/session for 8-12 weeks.
Receives: Behavioral: Physical Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reach

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

    Measured: Through study completion, an average of 6 years.

Secondary outcomes (19)
  1. Attendance

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

    Measured: Through study completion, an average of 6 years.

  2. Adherence

    Number of assessments completed out of number of scheduled assessments.

    Measured: Through study completion, an average of 6 years.

  3. 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.

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  4. 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.

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  5. 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).

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  6. Lower Extremity Endurance

    30-second sit to stand test (more sit/stands indicates greater lower extremity endurance).

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  7. Balance

    Flamingo balance test (longer time without falling, reaching, shuffling/jumping indicates better balance).

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  8. Range of Motion

    Shoulder range of motion (ROM; greater number indicates greater ROM).

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  9. Flexibility

    sit and reach flexibility (greater distance indicates higher flexibility).

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  10. Aerobic Capacity

    Aerobic step tests (more steps indicates higher aerobic capacity).

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  11. 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.

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  12. 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.

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  13. 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.

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  14. 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.

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  15. Maintenance of Physical Activity

    Number of participants who maintain physical activity following the program.

    Measured: Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)

  16. Physical Activity Fidelity

    Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of sessions.

    Measured: Through study completion, an average of 6 years.

  17. Time to Implement and Deliver

    Time and expertise to deliver the intervention and physical assessments will be tracked.

    Measured: Through study completion, an average of 6 years.

  18. Adverse Events

    Adverse events will be defined as any negative effect caused (or suspected to be caused by) the physical activity program.

    Measured: Through study completion, an average of 6 years.

  19. Healthcare Provider and Staff Uptake

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

    Measured: Through study completion, an average of 6 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2021
  2. Study start3 Aug 2022
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04956133
Sponsor's protocol ID
HREBA.CC-20-0364
Status last verified
Feb 2025
First submitted
11 Jun 2021
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

    PubMed 4053261
  • Thorsteinsson T, Helms AS, Adamsen L, Andersen LB, Andersen KV, Christensen KB, Hasle H, Heilmann C, Hejgaard N, Johansen C, Madsen M, Madsen SA, Simovska V, Strange B, Thing LF, Wehner PS, Schmiegelow K, Larsen HB. Study protocol: Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer (RESPECT). BMC Cancer. 2013 Nov 14;13:544. doi: 10.1186/1471-2407-13-544.

    PubMed 24229362
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PubMed 1991946
  • Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.

    PubMed 7624188
  • Deforche B, Lefevre J, De Bourdeaudhuij I, Hills AP, Duquet W, Bouckaert J. Physical fitness and physical activity in obese and nonobese Flemish youth. Obes Res. 2003 Mar;11(3):434-41. doi: 10.1038/oby.2003.59.

    PubMed 12634442
  • Canadian Society of Exercise Physiology. (2019). The CSEP physical activity training for health resource manual, 2nd edition.

  • McNeely ML, Sellar C, Williamson T, Shea-Budgell M, Joy AA, Lau HY, Easaw JC, Murtha AD, Vallance J, Courneya K, Mackey JR, Parliament M, Culos-Reed N. Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. BMJ Open. 2019 Sep 13;9(9):e029975. doi: 10.1136/bmjopen-2019-029975.

    PubMed 31519676
  • Muir SW, Corea CL, Beaupre L. Evaluating change in clinical status: reliability and measures of agreement for the assessment of glenohumeral range of motion. N Am J Sports Phys Ther. 2010 Sep;5(3):98-110.

    PubMed 21589666
  • Lemmink KA, Kemper HC, de Greef MH, Rispens P, Stevens M. The validity of the sit-and-reach test and the modified sit-and-reach test in middle-aged to older men and women. Res Q Exerc Sport. 2003 Sep;74(3):331-6. doi: 10.1080/02701367.2003.10609099. No abstract available.

    PubMed 14510299
  • Kolber MJ, Hanney WJ. The reliability and concurrent validity of shoulder mobility measurements using a digital inclinometer and goniometer: a technical report. Int J Sports Phys Ther. 2012 Jun;7(3):306-13.

    PubMed 22666645
  • Jankowski M, Niedzielska A, Brzezinski M, Drabik J. Cardiorespiratory fitness in children: a simple screening test for population studies. Pediatr Cardiol. 2015 Jan;36(1):27-32. doi: 10.1007/s00246-014-0960-0. Epub 2014 Jul 29.

    PubMed 25070386
  • Haas F, Sweeney G, Pierre A, Plusch T, Whiteson J. Validation of a 2 minute step test for assessing functional improvement. Open J Therap Rehab. 2017;5(02):71.

  • Varni JW, Limbers CA. The pediatric quality of life inventory: measuring pediatric health-related quality of life from the perspective of children and their parents. Pediatr Clin North Am. 2009 Aug;56(4):843-63. doi: 10.1016/j.pcl.2009.05.016.

    PubMed 19660631
  • Hyslop S, Dupuis LL, Baggott C, Dix D, Gibson P, Kuczynski S, Johnston DL, Orsey A, Portwine C, Price V, Spiegler B, Tomlinson D, Vanan M, Tomlinson GA, Sung L. Validation of the Proxy Version of Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Pain Symptom Manage. 2018 Jul;56(1):107-112. doi: 10.1016/j.jpainsymman.2018.03.025. Epub 2018 Apr 6.

    PubMed 29630923
  • Gioia GA, Issquith PK, Guy SC, Kenworthy L. Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2). 2015. Lutz, FL: PAR Inc.

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity in people with Pediatric Cancer and Pediatric Hematology, run by University of Calgary at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact S. Nicole Culos-Reed, PhD (403-220-7540, nculosre@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach (time frame: Through study completion, an average of 6 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04956133, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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