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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Cancer; Pediatric Hematology
• Intervention / Treatment: Behavioral: Physical Activity

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	The number of people who participate, and reasons why or why not.	Through study completion, an average of 6 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	Number of sessions attended out of the number of sessions offered by study staff.	Through study completion, an average of 6 years.
Adherence	Number of assessments completed out of number of scheduled assessments.	Through study completion, an average of 6 years.
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.	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	7-day wear period (minimum) with an activity monitor. Higher numbers indicate greater time spent in physical activity and intensity.	Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
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).	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	30-second sit to stand test (more sit/stands indicates greater 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	Flamingo balance test (longer time without falling, reaching, shuffling/jumping indicates better 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	Shoulder range of motion (ROM; greater number indicates greater ROM).	Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
Flexibility	sit and reach flexibility (greater distance indicates higher 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	Aerobic step tests (more steps indicates higher 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	PedsQL 3.0 Cancer Module (Varni et al., 2009). Score range 0-100; higher scores indicate better 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	PedsQL 4.0 Generic Core Scales (Varni et al., 2009). Score range 0-100; higher scores indicate better 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	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.	Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
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.	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	Number of participants who maintain physical activity following the program.	Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52)
Physical Activity Fidelity	Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of sessions.	Through study completion, an average of 6 years.
Time to Implement and Deliver	Time and expertise to deliver the intervention and physical assessments will be tracked.	Through study completion, an average of 6 years.
Adverse Events	Adverse events will be defined as any negative effect caused (or suspected to be caused by) the physical activity program.	Through study completion, an average of 6 years.
Healthcare Provider and Staff Uptake	Healthcare providers' and clinical staffs' referral to the physical activity program	Through study completion, an average of 6 years.

Collaborators and Investigators

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

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 3, 2022
• Primary Completion (ANTICIPATED): December 1, 2027
• Study Completion (ANTICIPATED): June 1, 2028

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (ACTUAL): July 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Oncology; Childhood cancer; Hematology; In-patient; Adolescent cancer; Out-patient
• Other Study ID Numbers: HREBA.CC-20-0364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No