Pediatric Physical Activity for Children With Cancer

NCT06012825 | Completed

• 1 other identifier: 2021-084
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

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:

1. 1.Determine the feasibility of administering the program and patient acceptability.
2. 2.Report program adherence and completion rates.
3. 3.Explore trends on the impact of a virtual PA intervention on psychosocial health and physical fitness.

Conditions

Pediatric Cancer; Physical Activity

Outcome Measures

Primary Outcomes (6)

• Enrollment

  The number of enrolled patients

  Tracked at the time of enrollment

• Duration in minutes

  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.

  Duration (minutes) will be measured each session up to 12 weeks.

• Heart Rate

  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.

  Intensity ( heart rate) will be measured each session up to 12 weeks.

• Relative Rate of Perceived Exertion

  Rate of perceived exertion (RPE) will be obtained from participants as a subjective measure of intensity.

  Intensity (RPE) will be measured each session up to 12 weeks.

• Acceptability of the program by patients

  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.

  Focus groups will be conducted up to 12 weeks.

• Adherence

  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).

  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.

Secondary Outcomes (11)

• Health-related quality of life (QL)

  Change from baseline QL at 12 weeks.

• Physical Activity Intention

  Change from baseline physical activity intention at 12 weeks.

• Social Support

  Change from baseline Social Support at 12 weeks.

• Fatigue

  Change from baseline Fatigue at 12 weeks.

• Depression

  Change from baseline Depression at 12 weeks.

Study Arms (2)

Physical Activity (PA) Round 1

All enrollees will have the opportunity to attend virtual PA sessions.

Behavioral: Physical Activity

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.

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

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).

Physical Activity (PA) Round 1; Physical Activity Round 2

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred by their physician at a primary care facility.

You may qualify if:

• 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.

You may not qualify if:

• Not having been diagnosed with cancer.
• Inability to communicate in English
• Requires physical or occupational therapy.

Sponsors & Collaborators

• University of Hawaii: lead
• Hawaii Pacific Health: collaborator
• University of Hawaii Cancer Research Center: collaborator

Study Sites (3)

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii at Manoa

Honolulu, Hawaii, 96822, United States

Location

Kapi'olani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Related Publications (8)

• 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.

  PMID: 31407493 BACKGROUND

• 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.

  PMID: 19168920 BACKGROUND

• 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.

  PMID: 11932914 BACKGROUND

• 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.

  PMID: 24038960 BACKGROUND

• 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.

  PMID: 17057441 BACKGROUND

• 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.

  PMID: 23863415 BACKGROUND

• 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.

  PMID: 34398076 BACKGROUND

• 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

  RESULT

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paulette Yamada Tamashiro, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: August 28, 2023
• Study Start: January 1, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 12, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

US (3)