CanMove: The Feasibility of Implementing a Physical Activity Intervention for Children Undergoing Acute Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Practicality of the intervention: adverse events
研究概览
简要总结
This study will evaluate a physical activity intervention for children during acute cancer treatment. The intervention aims to encourage children to participate in increased levels of physical activity and reduce the amount of time they spend engaged in sedentary activities. This study also aims to evaluate different ways of assessing physical function in order to determine the best outcome measure to use for children during acute cancer treatment.
详细描述
All participants will receive the intervention which involves weekly sessions with a physiotherapist and the provision of an activity tracker. The sessions will aim to help motivate participants to be more physically active and identify barriers to physical activity in their environment. The activity tracker will be used to set a steps per day goal for the participant to achieve.
The intervention will be assessed for feasibility using aspects of the Bowen Framework. Under this framework the intervention will be evaluated according to different domains:
- Acceptability: To what extent is a new idea, program, process or measure judged as suitable or satisfying
- Demand: To what extent is a new idea, program, process, or measure likely to be used
- Implementation: To what extent can a new program is successfully delivered to intended participants
- Practicality: To what extent can the program can be carried out with intended participants using existing means, resources, and circumstances
- Limited efficiency: Does the a new program show promise of being successful with the intended population
In order to find out the best way to assess physical function, participants will complete 5 different assessments. The results from these assessments will help to determine the best measure to use in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is between the ages of 5-17 years at the time of consent
- •Diagnosed (or relapsed) with cancer >4 weeks and <6 months at time of consent
- •Currently receiving cancer treatment at the Royal Children's Hospital
- •Has been an in-patient for >7 consecutive days at the time of consent
- •Provide a signed and dated informed consent form and/or has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf
排除标准
- •Deemed by the treating medical team as unsafe to participate
- •Child/adolescent unable to mobilise independent of clinical staff assistance, as classified by the research team at the time of consent (use of a gait aid or assistance from a primary carer/support person is accepted). For example, if a child/adolescent requires assistance from nursing staff or physiotherapist in order to walk, they will be excluded.
- •Child/adolescent unable to follow simple instructions
- •Suitable support person (18 years and over) not available to participate in continuous monitoring of daily steps in tandem with the child/adolescent
- •No suitable access to a device to sync with a Fitbit
- •Inability or unwillingness of participant or legally acceptable representative to give written informed consent.
结局指标
主要结局
Practicality of the intervention: adverse events
时间窗: Post the participant's final trial visit (on average 12 weeks)
Measured by number of adverse events reported related to trial procedures. At each trial visit, participants will be asked "How have you felt since your last visit?" in order to elicit any changes in their well-being. They will also be asked if they have had any falls, new injuries, felt distress as a result of the intervention or experienced a change in medical or mobility status. Adverse events relevant to participant safety will also be documented from correspondence from their primary care physician or from the medical record. Adverse events recorded as serious or non-serious, related or not related to the intervention.
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit physical activity intensity
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in time spent in different physical activity intensities (sedentary, light, moderate-vigorous and vigorous) measured by the Fitbit
Implementation of the intervention: attendance to intervention sessions
时间窗: Post intervention (on average 8 weeks)
Adherence to attending intervention sessions, percentage of intervention sessions that were attended
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph distance travelled per day
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in average distance travelled per day measured via the Actigraph
Acceptability of the intervention according to participants
时间窗: After completion of the intervention (on average 8 weeks)
Participant and participant guardian perspective on intervention satisfaction and potential areas of improvement via semi-structured interviews
Acceptability of the intervention according to staff
时间窗: Through study completion, estimated as 1 year
Staff perspective on intervention satisfaction and potential areas of improvement via focus groups with staff members
Implementation of the intervention: adherence to wearing Fitbit
时间窗: Post intervention (on average 8 weeks)
Adherence to wearing the Fitbit for monitoring, percentage of complete Fitbit data days out of total intervention days
Limited efficiency testing assessing changes in physical activity between pre and post intervention: body position
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in time spent in each body position per day measured via the Actigraph
Implementation of the intervention: ability for participants to attain their steps per day goal
时间窗: Post intervention (on average 8 weeks)
Goal attainment, percentage of days out of total intervention days that participant was able to achieve their steps per day target
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph steps per day
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in average steps taken per day measured via the Actigraph
Limited efficiency testing assessing changes in physical activity between pre and post intervention: sedentary bouts
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in number of sedentary bouts per day measured via the Actigraph
Demand for the intervention
时间窗: Through completion of recruitment, estimated as 9 months
Recruitment rate (comparing the number of people recruited to the number of potentially eligible participants), and documenting the reasons for non-participation.
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit steps per day
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in average steps taken per day measured via the Fitbit
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph physical activity intensity
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in time spent in different physical activity intensities (sedentary, light, moderate-vigorous and vigorous) measured by the Actigraph
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit distance travelled per day
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in average distance travelled per day measured via the Fitbit
Limited efficiency testing assessing changes in physical activity between pre and post intervention: active hours
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in number of active hours per day measured via the Fitbit
Limited efficiency testing assessing changes in physical activity between pre and post intervention: active minutes
时间窗: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in number of active minutes per day measured via the Fitbit
次要结局
- Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: self-reported Pediatric Quality of Life Inventory-core generic module(Post intervention (on average 8 weeks))
- Utility of physical activity assessment tools, measured by completeness of assessment data for physical activity(Post completion of follow up assessment (on average 10 weeks))
- Limited efficiency testing assessing changes in physical function from pre to post intervention: 6 Minute Walk Test(Post intervention (on average 8 weeks))
- Feasibility: Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: self-reported PedsQL-cancer module(Post intervention (on average 8 weeks))
- Categorisation and frequency of action plan strategies(Post intervention (on average 8 weeks))
- Limited efficiency testing assessing changes in physical function from pre to post intervention: Movement ABC(Post intervention (on average 8 weeks))
- Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Go(Post intervention (on average 8 weeks))
- Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Down Stairs(Post intervention (on average 8 weeks))
- Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: proxy-reported Pediatric Quality of Life Inventory-core generic module(Post intervention (on average 8 weeks))
- Feasibility: Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: proxy-reported PedsQL-cancer module(Post intervention (on average 8 weeks))
- Categorisation and frequency of reported barriers to physical activity(Post intervention (on average 8 weeks))
- Utility of physical function assessment tools, measured by completeness of assessment data for physical function(Post completion of follow up assessment (on average 10 weeks))
- Limited efficiency testing assessing changes in physical function from pre to post intervention: Time to Rise from the Floor(Post intervention (on average 8 weeks))