Pediatric Physical Activity (PePA): Understanding Best Practices in Implementing Physical Activity for Patients Diagnosed With Childhood Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Acceptability of the program by patients
研究概览
简要总结
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:
- Determine the feasibility of administering the program and patient acceptability.
- Report program adherence and completion rates.
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Not having been diagnosed with cancer.
- •Inability to communicate in English
- •Requires physical or occupational therapy.
结局指标
主要结局
Acceptability of the program by patients
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Tracked at the time of enrollment
The number of enrolled patients
次要结局
- 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.)
研究者
Paulette M. Yamada
Associate Professor
University of Hawaii