Clinical Trials Directory

Trials / Completed

CompletedNCT06012825

Pediatric Physical Activity for Children With Cancer

Pediatric Physical Activity (PePA): Understanding Best Practices in Implementing Physical Activity for Patients Diagnosed With Childhood Cancer

Status
Completed
Phase
Study type
Observational
Enrollment
12 (actual)
Sponsor
University of Hawaii · Academic / Other
Sex
All
Age
5 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPhysical ActivityThe 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).

Timeline

Start date
2022-01-01
Primary completion
2023-05-09
Completion
2023-05-12
First posted
2023-08-28
Last updated
2023-11-21

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06012825. Inclusion in this directory is not an endorsement.