Clinical trial NCT06012825: Pediatric Physical Activity for Children With Cancer
Official title: Pediatric Physical Activity (PePA): Understanding Best Practices in Implementing Physical Activity for Patients Diagnosed With Childhood Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer
Physical Activity
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Hawaii Pacific Health
name: University of Hawaii Cancer Research Center
First posted: 2023-08-28
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred by their physician at a primary care facility.

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. Determine the feasibility of administering the program and patient acceptability.
2. Report program adherence and completion rates.
3. 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.

Detailed description: It is critical for childhood cancer patients to maintain a physical activity (PA) regime as they are at an increased risk of developing co-morbidities. PA engagement is associated with positive psychosocial outcomes, and it has the potential to improve cardiopulmonary and musculoskeletal function. Patients will be enrolled and will undergo baseline assessments of fitness and quality of life as part of their standard care, and additional measures that include fatigue, depression, social support, and PA volume will be measured. Patients will be invited to participate in a 12-week virtual PA intervention with similar-aged peers (2x/week, 60 minutes/session). Patients will be led through activities that are culturally relevant and age-appropriate. At the end of the 12-week intervention, the same tests will be completed. The patients will have an opportunity to receive 2 interventions. A mixed method design will be used, where quantitative data will include information related to feasibility, PA volume, physical fitness, and psychosocial health measures, and qualitative data will be collected from the patients during the focus groups.

Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment
timeFrame: Tracked at the time of enrollment
measure: Duration in minutes
timeFrame: Duration (minutes) will be measured each session up to 12 weeks.
measure: Heart Rate
timeFrame: Intensity ( heart rate) will be measured each session up to 12 weeks.
measure: Relative Rate of Perceived Exertion
timeFrame: Intensity (RPE) will be measured each session up to 12 weeks.
measure: Acceptability of the program by patients
timeFrame: Focus groups will be conducted up to 12 weeks.
measure: Adherence
timeFrame: 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:
measure: Health-related quality of life (QL)
timeFrame: Change from baseline QL at 12 weeks.
measure: Physical Activity Intention
timeFrame: Change from baseline physical activity intention at 12 weeks.
measure: Social Support
timeFrame: Change from baseline Social Support at 12 weeks.
measure: Fatigue
timeFrame: Change from baseline Fatigue at 12 weeks.
measure: Depression
timeFrame: Change from baseline Depression at 12 weeks.
measure: Cardiorespiratory endurance
timeFrame: Change from baseline Cardiorespiratory Endurance at 12 weeks.
measure: Flexibility
timeFrame: Change from baseline Flexibility at 12 weeks.
measure: Hand Strength
timeFrame: Change from baseline Hand Strength at 12 weeks.
measure: Muscular Strength
timeFrame: Change from baseline Muscular Strength at 12 weeks.
measure: Balance
timeFrame: Change from baseline Balance at 12 weeks.
measure: Activity of daily living (ADL)
timeFrame: Change from baseline ADL at 12 weeks..
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii at Manoa
state: Hawaii
city: Honolulu
country: United States
facility: Kapi'olani Medical Center for Women and Children
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Paulette Yamada Tamashiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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