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Clinical Trials/NCT06012825
NCT06012825
Completed
Not Applicable

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

University of Hawaii3 sites in 1 country12 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Cancer
Sponsor
University of Hawaii
Enrollment
12
Locations
3
Primary Endpoint
Acceptability of the program by patients
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
May 12, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Hawaii
Responsible Party
Principal Investigator
Principal Investigator

Paulette M. Yamada

Associate Professor

University of Hawaii

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.

Outcomes

Primary Outcomes

Acceptability of the program by patients

Time Frame: Focus groups will be conducted up to 12 weeks.

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.

Duration in minutes

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

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.

Heart Rate

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

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.

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.

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).

Relative Rate of Perceived Exertion

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

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

Enrollment

Time Frame: Tracked at the time of enrollment

The number of enrolled patients

Secondary Outcomes

  • Physical Activity Intention(Change from baseline physical activity intention at 12 weeks.)
  • Cardiorespiratory endurance(Change from baseline Cardiorespiratory Endurance at 12 weeks.)
  • Hand Strength(Change from baseline Hand Strength at 12 weeks.)
  • Social Support(Change from baseline Social Support at 12 weeks.)
  • Muscular Strength(Change from baseline Muscular Strength at 12 weeks.)
  • Fatigue(Change from baseline Fatigue at 12 weeks.)
  • Depression(Change from baseline Depression at 12 weeks.)
  • Balance(Change from baseline Balance at 12 weeks.)
  • Activity of daily living (ADL)(Change from baseline ADL at 12 weeks..)
  • Health-related quality of life (QL)(Change from baseline QL at 12 weeks.)
  • Flexibility(Change from baseline Flexibility at 12 weeks.)

Study Sites (3)

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