- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012825
Pediatric Physical Activity for Children With Cancer (PePA)
Pediatric Physical Activity (PePA): Understanding Best Practices in Implementing Physical Activity for Patients Diagnosed With Childhood Cancer
The goal of this pilot study is to test the feasibility and participant adherence (pediatric patients diagnosed with childhood cancer) to a virtual, 12-week physical activity program.
The aims of this project are to:
- Determine the feasibility of administering the program and patient acceptability.
- Report program adherence and completion rates.
- Explore trends on the impact of a virtual PA intervention on psychosocial health and physical fitness.
Participants will undergo pre- and post-assessments including measurements of fitness, self-reported fatigue and depression symptoms, social support, and current amount of physical activity. Patients will then be invited to participate in two consecutive, 12-week virtual physical activity interventions with similar-aged peers (2x/week, 60 minutes/session) over 2 rounds.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hawaii
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Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, United States, 96822
- University of Hawaii at Manoa
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Honolulu, Hawaii, United States, 96826
- Kapi'olani Medical Center for Women and Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Having been diagnosed with cancer
- Ability to connect to virtual sessions 2x/week
- English literacy
- Having guardian consent and patient assent.
- Eligible patients will be those who do not require physical therapy (i.e., able to dress, ambulate) and will be physically able to participate, as determined by therapy staff.
Exclusion Criteria:
- Not having been diagnosed with cancer.
- Inability to communicate in English
- Requires physical or occupational therapy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Physical Activity (PA) Round 1
All enrollees will have the opportunity to attend virtual PA sessions.
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The program will consist of 2 consecutive rounds of 12-week programming, 2x/week for 60 minutes on a Health Insurance Portability and Accountability Act (HIPAA)-compliant Zoom account.
The PA program will be structured to ensure equivalent "PA doses" are provided.
This will be done by allocating time to a warm-up (5 min), an introduction and demonstration of the activity (5 min), the PA (30 min), cool down and stretching (5 min).
Time will also be devoted for interaction to develop rapport, transition to the next activity, and to handle internet connectivity issues (15 min).
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Physical Activity Round 2
This second cohort is the 2nd round of intervention, which allows participants to enroll for another round, and/or newly recruited patients will have the opportunity to participate.
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The program will consist of 2 consecutive rounds of 12-week programming, 2x/week for 60 minutes on a Health Insurance Portability and Accountability Act (HIPAA)-compliant Zoom account.
The PA program will be structured to ensure equivalent "PA doses" are provided.
This will be done by allocating time to a warm-up (5 min), an introduction and demonstration of the activity (5 min), the PA (30 min), cool down and stretching (5 min).
Time will also be devoted for interaction to develop rapport, transition to the next activity, and to handle internet connectivity issues (15 min).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enrollment
Time Frame: Tracked at the time of enrollment
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The number of enrolled patients
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Tracked at the time of enrollment
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Acceptability of the program by patients
Time Frame: Focus groups will be conducted up to 12 weeks.
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The virtual activities also need to enjoyable, so with the use of focus groups, patient acceptability of the program will be determined.
Predetermined questions and prompts will be used, such as, "Describe a lesson or lessons you liked best.
What are some lessons that were less enjoyable?
What was the most difficult aspect of participating in PePA?
In general, did the exercises feel like they provided the right amount of exertion, too intense, not intense enough?
Was the duration of each session too long, too short or about right?".
The focus group recording will be transcribed and themes will be identified in this qualitative analysis.
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Focus groups will be conducted up to 12 weeks.
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Adherence
Time Frame: Attendance will be measured each week up to 12 weeks. If the participant continues for a second round, adherence will be measured each week during the second intervention up to 12 weeks.
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The number of completing patients.
This will be measured by counting the number of participants who completed the majority of the program for each round (i.e., 20 out of 24 sessions).
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Attendance will be measured each week up to 12 weeks. If the participant continues for a second round, adherence will be measured each week during the second intervention up to 12 weeks.
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Duration in minutes
Time Frame: Duration (minutes) will be measured each session up to 12 weeks.
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The investigators will determine if the delivery of a virtual physical activity program is feasible by tracking the number of minutes spent in the warm up, activity and cool-down.
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Duration (minutes) will be measured each session up to 12 weeks.
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Heart Rate
Time Frame: Intensity ( heart rate) will be measured each session up to 12 weeks.
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In order to objectively measure the intensity level and volume of PA during the activity sessions, participants will wear accelerometers on their waist and a wrist-based heart rate will be used to intensity of PA in real-time.
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Intensity ( heart rate) will be measured each session up to 12 weeks.
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Relative Rate of Perceived Exertion
Time Frame: Intensity (RPE) will be measured each session up to 12 weeks.
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Rate of perceived exertion (RPE) will be obtained from participants as a subjective measure of intensity.
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Intensity (RPE) will be measured each session up to 12 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related quality of life (QL)
Time Frame: Change from baseline QL at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program with the following measure: Quality of life with the Pediatric Quality of Life Inventory General Well-Being Scale (PedsQL Inventory, 23 items). Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores reflect better outcomes. |
Change from baseline QL at 12 weeks.
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Physical Activity Intention
Time Frame: Change from baseline physical activity intention at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program on the following measure: Physical Activity (PA) intention with the PA Intention Inventory (6 items). The first 3 items ask about the number of days over the past week the participant engaged in PA for 60 minutes, the number of days PA was engaged which resulted in elevated heart rate, and the number of days that the participant engaged in resistance exercises. Responses range from 0-7 days with greater days indicating more activity. The last 3 questions ask the participant about his/her intention to engage in PA outside of school, participate in PA which makes him/her breathe hard in the next 2 weeks and if s/he expects to exercise outside of school that makes him/her breathe hard in the next 2 weeks. Answers correspond to 0=strongly agree, 1=agree, 2= not sure, 3=disagree, 4=strongly disagree. Scores range from 0-12, with lower scores reflecting better outcomes. |
Change from baseline physical activity intention at 12 weeks.
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Social Support
Time Frame: Change from baseline Social Support at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program on the following measure: Social support toward PA from friends and parents (Social Support Questionnaire, 8 items). Items are answered with very often (0), often (1), neutral (2), sometimes (3) or never (4). Scores range from 0 to 32. Lower scores represent better outcomes. |
Change from baseline Social Support at 12 weeks.
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Fatigue
Time Frame: Change from baseline Fatigue at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program on the following measure: Fatigue using the PedsQL Multidimensional Fatigue Scale Questionnaire (18 items). Items are transformed to a 0-100 scale, where 0=100, 1=75, 3=25, 4=0. Scores are averaged (divided by 18) and range from 0-100. Higher scores indicate fewer problems. |
Change from baseline Fatigue at 12 weeks.
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Depression
Time Frame: Change from baseline Depression at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program on the following measure: Depression using the Children's Depression Inventory (12 items). Items 1, 3-6, 8, 10-12 correspond to emotional problems. Items 2, 7, 9, 13-17 correspond to function problems. Reverse scoring is used for items 2, 7, 13, 14, 16. Higher scores indicate greater problems. Scores are compared to normative ranges (0-39+), which are age- and sex-dependent. |
Change from baseline Depression at 12 weeks.
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Cardiorespiratory endurance
Time Frame: Change from baseline Cardiorespiratory Endurance at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program on the following measure: Cardiorespiratory endurance using the 6-minute walk test (ml/kg/min). |
Change from baseline Cardiorespiratory Endurance at 12 weeks.
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Flexibility
Time Frame: Change from baseline Flexibility at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program on the following measure: Range of motion using goniometry (degrees). |
Change from baseline Flexibility at 12 weeks.
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Hand Strength
Time Frame: Change from baseline Hand Strength at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program on the following measure: Hand strength will be measured with hand-held dynamometry (kg). |
Change from baseline Hand Strength at 12 weeks.
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Muscular Strength
Time Frame: Change from baseline Muscular Strength at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program on the following measure: A manual muscle testing (scale that rates trace, poor, fair, good, normal performance) will be used to measure Muscular Strength. |
Change from baseline Muscular Strength at 12 weeks.
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Balance
Time Frame: Change from baseline Balance at 12 weeks.
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The investigators will explore the trends of a virtual physical activity program on the following measure: Balance using the Berg Balance Scale (14 items). Scores range from 0 to 56 with higher scores reflecting better outcomes. |
Change from baseline Balance at 12 weeks.
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Activity of daily living (ADL)
Time Frame: Change from baseline ADL at 12 weeks..
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The investigators will explore the trends of a virtual physical activity program on the following measure: Assessment of the ability to perform activities of daily living (ADL, QuickDASH Inventory, 11 items). Items are scored as no difficulty (1), mild difficulty (2), moderate difficulty (3), severe difficult (4), to unable to achieve (5). At least 10 items need to be completed and is measured on a scale of 0-100 with a higher score indicating greater disability. |
Change from baseline ADL at 12 weeks..
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paulette Yamada Tamashiro, PhD, University of Hawaii
Publications and helpful links
General Publications
- Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
- Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
- Quatman-Yates CC, Gupta R, Paterno MV, Schmitt LC, Quatman CE, Ittenbach RF. Internal consistency and validity of the QuickDASH instrument for upper extremity injuries in older children. J Pediatr Orthop. 2013 Dec;33(8):838-42. doi: 10.1097/BPO.0b013e3182a00688.
- Ouyang N, Cai R, Zhou X, Huang H, Qiu X, Liu K. Effects of a group-based physical activity program for pediatric patients with cancer on physical activity and symptom experience: A quasi-experimental study. Pediatr Blood Cancer. 2019 Nov;66(11):e27965. doi: 10.1002/pbc.27965. Epub 2019 Aug 12.
- Honas JJ, Washburn RA, Smith BK, Greene JL, Cook-Wiens G, Donnelly JE. The System for Observing Fitness Instruction Time (SOFIT) as a measure of energy expenditure during classroom-based physical activity. Pediatr Exerc Sci. 2008 Nov;20(4):439-45. doi: 10.1123/pes.20.4.439.
- Panepinto JA, Torres S, Bendo CB, McCavit TL, Dinu B, Sherman-Bien S, Bemrich-Stolz C, Varni JW. PedsQL Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity. Pediatr Blood Cancer. 2014 Jan;61(1):171-7. doi: 10.1002/pbc.24776. Epub 2013 Sep 13.
- Rider BC, Conger SA, Ditzenberger GL, Besteman SS, Bouret CM, Coughlin AM. Examining the Accuracy of the Polar A360 Monitor. J Strength Cond Res. 2021 Aug 1;35(8):2165-2169. doi: 10.1519/JSC.0000000000003136.
- Yamada PM, Centeio EC, Bantum EO, Cao S, Lopez GM. Informing the delivery of physical activity leadership for pediatric patients undergoing cancer treatment. International Journal of Kinesiology in Higher Education, Sept 2023. DOI: 10.1080/24711616.2023.2237427
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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