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

NCT ID: NCT04956133

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-03

Study Completion Date

2028-06-01

Brief Summary

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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

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Conditions

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Pediatric Cancer Pediatric Hematology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physical activity

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

Group Type EXPERIMENTAL

Physical Activity

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Children's Hospital

OTHER

Sponsor Role collaborator

Stollery Children's Hospital

OTHER

Sponsor Role collaborator

Canadian Cancer Society (CCS)

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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S. Nicole Culos-Reed, PhD

Role: CONTACT

403-220-7540

Facility Contacts

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Emma McLaughlin PhD Candidate, MSc

Role: primary

1-403-210-8482

Emma McLaughlin PhD Candidate, MSc

Role: primary

1-403-210-8482

References

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Reference Type BACKGROUND
PMID: 4053261 (View on PubMed)

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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 7624188 (View on PubMed)

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Reference Type BACKGROUND
PMID: 12634442 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 21589666 (View on PubMed)

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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 22666645 (View on PubMed)

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.

Reference Type BACKGROUND
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Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19660631 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29630923 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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HREBA.CC-20-0364

Identifier Type: -

Identifier Source: org_study_id

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