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Completed

NCT Number: NCT06012825

Pediatric Physical Activity for Children With 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:

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.

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Key information

Conditions

Pediatric Cancer Behavior Motor Activity Neoplasms Physical Activity

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kapi'olani Medical Center for Women and Children, Honolulu, Hawaii, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Enrollment

    Time frame: Tracked at the time of enrollment

    The number of enrolled patients

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

Secondary outcomes

  1. Health-related quality of life (QL)

    Time frame: Change from baseline QL at 12 weeks.

    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.

  2. Physical Activity Intention

    Time frame: Change from baseline physical activity intention at 12 weeks.

    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.

  3. Social Support

    Time frame: Change from baseline Social Support at 12 weeks.

    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.

  4. Fatigue

    Time frame: Change from baseline Fatigue at 12 weeks.

    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.

  5. Depression

    Time frame: Change from baseline Depression at 12 weeks.

    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.

  6. Cardiorespiratory endurance

    Time frame: Change from baseline Cardiorespiratory Endurance at 12 weeks.

    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).

  7. Flexibility

    Time frame: Change from baseline Flexibility at 12 weeks.

    The investigators will explore the trends of a virtual physical activity program on the following measure:

    Range of motion using goniometry (degrees).

  8. Hand Strength

    Time frame: Change from baseline Hand Strength at 12 weeks.

    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).

  9. Muscular Strength

    Time frame: Change from baseline Muscular Strength at 12 weeks.

    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.

  10. Balance

    Time frame: Change from baseline Balance at 12 weeks.

    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.

  11. Activity of daily living (ADL)

    Time frame: Change from baseline ADL at 12 weeks..

    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.

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • Hawaii Pacific Health
  • University of Hawaii Cancer Research Center

Registry information

Official study title

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

Acronym: PePA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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