Effectiveness of an Integrated Programme in Promoting the Regular Physical Activity Among Childhood Cancer Survivors
Effectiveness of an Integrated Adventure-Based Training and Health Education Programme in Promoting the Adoption and Maintenance of Regular Physical Activity Among Childhood Cancer Survivors
Background.There is some evidence that engaging in regular moderate-intensity physical activity may help ameliorate cancer-related fatigue experienced by childhood cancer survivors, which eventually improve their quality of life. Nevertheless, there is growing concern about declining levels of physical activity in childhood cancer survivors.
Purposes. To examine the effectiveness of an integrated adventure-based training and health education programme in promoting the adoption and maintenance of regular physical activity, reducing fatigue and improving the quality of life among Hong Kong Chinese childhood cancer survivors.
Design and Subjects. A randomised controlled trial (RCT), two-group pre-test and repeated post-test, between subjects design was conducted. Recruitment of subjects was carried out through the Sunshine Parents Club, which is a non-profit voluntary organization with the aim to provide education and psychological support to parents of Hong Kong Chinese childhood cancer survivors.
Intervention. Participants in the placebo control group received an amount of time and attention (leisure activities organized by a community centre) that mimicked that received by the experimental group. Participants in the experimental group joined a four-day integrated adventure-based training and health education programme, which contained education talks, a workshop and adventure-based training activities.
研究概览
详细说明
The aim of this study was to examine the effectiveness of an integrated adventure-based training and health education programme in promoting the exercise behavior changes, enhancing the physical activity levels, self-efficacy, reducing fatigue and improving the quality of life of Hong Kong Chinese childhood cancer survivors.
Intervention
Placebo control group
Participants received medical follow-up according to the schedule of the oncology units. Besides, participants received an amount of time and attention that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. They were invited to attend leisure activities organized by a community centre in four different days during the study period. Activities included cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park.
Experimental group
Besides receiving medical follow-up, participants joined a four-day integrated adventure-based training and health education programme, which contains education talks, a workshop to work out a feasible individual action plan for regular physical activity and adventure-based training activities. Previous research showed that working out individual action plan is important, which can increase the possibility for people to turn their intentions into health promotion action. The content of the education talks were tailor-made for participants in which they did not engage in regular physical activity.
To ensure the dosage of intervention delivered in terms of the amount, frequency, duration, and breadth would be adequate to assess the quality and to manage outcomes, such as physical activity levels, self-efficacy, stages of change and quality of life, the following measures were taken. An advisory committee was set up with the purpose to develop an appropriate integrated programme for Hong Kong Chinese childhood cancer survivors. The committee included the researcher, an assistant professor at a local university with considerable experience of conducting psychological interventions among children, a paediatric oncologist and a oncology nurse specialist with rich experience in taking care of children with cancer, two professional adventure-based trainers and one assistant professor of Sports and Recreation Management with extensive experience and professional knowledge in conducting adventure-based training for children. In addition, the content of the programme that related to adventure-based training activities was sent to a professional adventure-based training centre for content validation. The programme was implemented on four different days within six months in a day camp training centre, such as at 2-week, 2-month, 4-month and 6-month after the day of recruitment. The programme was implemented in small group with maximum 12 participants in one group. Health education talks and workshop were implemented in between adventure-based training activities in day camp centre, which were conducted by healthcare professionals working in a local university. Adventure-based training activities were led by two qualified adventure-based training instructors with extensive experience and professional knowledge in conducting such training for children. Additionally, at least two healthcare professionals joined the adventure-based training to monitor the physical condition of the survivors and their fitness to join the adventure-based training activities.
Data Collection Methods
Data Collection Methods Approval for the study was obtained from the hospital ethics committees. To identify potential subjects, a leaflet containing details of the study and a demographic sheet have been mailed to all parents of childhood cancer survivors in the Sunshine Parents Club. If children and their parents are interested in the research, they can return the demographic sheet by using the enclosed return-envelop to convey their willingness to participate in the study. A briefing session will then be conducted in the out-patient clinic to those eligible children and parents. Written consent has been obtained from the parents after they were told the purposes of the study, although they were of course given the option of allowing or refusing the involvement of their child. The children has also been invited to put their names on a special children's assent form and told that their participation is voluntary.
After obtaining demographic data of participants, they have been asked to respond to the Chinese version of the FS-C/FS-A, PA-SE, CUHK-PARCY, PASCQ and PedsQL. They have also been assessed for muscle strength using a hand-held dynamometer. Participants have been randomly assigned to the experimental and control groups. All participants received a telephone call inviting them to join the interventions according to their group assignment at an appointed time. Data collection has been conducted again at 3, 6, 9 and 12 months after starting the intervention. All participants has been informed that there would be home visits for data collection.
Analysis
The Statistical Package for Social Sciences (SPSS) software, version 19.0 for Windows will be used to analyze quantitative data. Intention-to-treat analysis will be used and missing data will be substituted by the last-observation-carried-forward procedure. The comparability of the experimental and control groups will be assessed by using inferential statistics (independent t-test and chi-squared test). Descriptive statistics will be used to calculate the mean scores and standard deviation of different scales. Mixed between-within subjects ANOVA (split-plot ANOVA) will be used to determine whether the adventure-based training programme was effective in reducing fatigue, increasing childhood cancer survivors' levels of physical activity, self-efficacy and muscle strength and enhancing their quality of life. In addition, Friedman Test will be used to determine any changes in stages of change between the experimental and control groups.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hong Kong、中国
- Queen Mary Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Hong Kong Chinese childhood cancer survivors defined here as having completed treatment at least six months previously
- between 7 and 18 years of age
- able to speak Cantonese and read Chinese
- did not engage in regular physical activity for the past 6 months
Exclusion Criteria:
- childhood cancer survivors with evidence of recurrence or second malignancies
- those with physical impairment or cognitive and learning problems identified from their medical records
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:health talk and adventure-based training
Participate will join a four-day integrated health education and adventure-based training programme, which contains education talks, workshop and adventure-based training activities.
The programme will be implemented on four different days within six months in a day camp training centre.
The integrated programme will be implemented in small group with maximum 15 participants in one group.
Health education talks and workshop will be implemented in between adventure-based training activities in day camp centre, which will be conducted by healthcare professionals working in a local university.
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To develop an integrated programme for Hong Kong Chinese childhood cancer survivors, an advisory committee was set up which included the three healthcare professionals (researchers), two school principals, two professional adventure-based trainers and one assistant professor of Sports and Recreation Management, ensuring the adequate 'dosage' of the intervention and the feasibility of implementing such programme for Hong Kong childhood cancer surviviors.
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安慰剂比较:Placebo Control
Participants will receive an amount of time and attention that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures.
They will be invited to attend leisure activities organized by a community centre in four different days during the study period.
Activities will include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park.
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They will be invited to attend leisure activities organized by a community centre in four different days during the study period.
Activities will include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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干预组和对照组之间 6 个月随访时癌症相关疲劳水平相对于基线的变化
大体时间:6个月的随访
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主要结果是两组在开始干预后 6 个月时的癌症相关疲劳水平。
疲劳量表 - 儿童将用于评估 7 至 12 岁受试者的疲劳程度。
对于 13 至 18 岁的人,他们的疲劳程度将通过疲劳量表 - 青少年来衡量。
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6个月的随访
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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干预组和对照组之间 3 个月随访时癌症相关疲劳水平相对于基线的变化
大体时间:3个月的随访
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疲劳量表 - 儿童将用于评估 7 至 12 岁受试者的疲劳程度。
对于 13 至 18 岁的人,他们的疲劳程度将通过疲劳量表 - 青少年来衡量。
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3个月的随访
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干预组和对照组之间 9 个月随访时癌症相关疲劳水平相对于基线的变化
大体时间:9个月的随访
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疲劳量表 - 儿童将用于评估 7 至 12 岁受试者的疲劳程度。
对于 13 至 18 岁的人,他们的疲劳程度将通过疲劳量表 - 青少年来衡量。
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9个月的随访
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干预组和对照组在 12 个月的随访中癌症相关疲劳水平相对于基线的变化
大体时间:12个月的随访
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疲劳量表 - 儿童将用于评估 7 至 12 岁受试者的疲劳程度。
对于 13 至 18 岁的人,他们的疲劳程度将通过疲劳量表 - 青少年来衡量。
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12个月的随访
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基线癌症相关疲劳水平
大体时间:基线
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疲劳量表 - 儿童将用于评估 7 至 12 岁受试者的疲劳程度。
对于 13 至 18 岁的人,他们的疲劳程度将通过疲劳量表 - 青少年来衡量。
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基线
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干预组和对照组在 6 个月的随访中体力活动水平相对于基线的变化
大体时间:6个月的随访
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参加者的身体活动水平将使用 CUHK-PARCY 进行评估,这是一个由 Jackson 活动编码和为青少年修改的 Godin-Shephard 活动问卷修改而来的 11 项活动评级。
参与者将被要求在开始干预后的 6 个月内对中文版的 CUHK-PARCY 做出回应。
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6个月的随访
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干预组和对照组在 9 个月的随访中体力活动水平相对于基线的变化
大体时间:9个月的随访
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参加者的身体活动水平将使用 CUHK-PARCY 进行评估,这是一个由 Jackson 活动编码和为青少年修改的 Godin-Shephard 活动问卷修改而来的 11 项活动评级。
参与者将被要求在开始干预后的 9 个月内对中文版的 CUHK-PARCY 做出回应。
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9个月的随访
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干预组和对照组在 12 个月的随访中体力活动水平相对于基线的变化
大体时间:12个月的随访
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参加者的身体活动水平将使用 CUHK-PARCY 进行评估,这是一个由 Jackson 活动编码和为青少年修改的 Godin-Shephard 活动问卷修改而来的 11 项活动评级。
参与者将被要求在开始干预后的 12 个月内对中文版的 CUHK-PARCY 做出回应。
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12个月的随访
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基线的身体活动水平活动
大体时间:基线
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参加者的身体活动水平将使用 CUHK-PARCY 进行评估,这是一个由 Jackson 活动编码和为青少年修改的 Godin-Shephard 活动问卷修改而来的 11 项活动评级。
在随机化之前,参与者将被要求回答中文版的 CUHK-PARCY。
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基线
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基线的变化阶段
大体时间:基线
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参与者锻炼模式的当前阶段将通过 PASCQ 的改编版本进行评估。
它是一个二元类型(是/否)问卷,包含四个项目。
参与者将用“是”或“否”回答关于他们的身体活动实践的每个问题。
根据这些回答,他们将通过评分算法分为五个不同的阶段。
在随机化之前,参与者将被要求回答中文版的 PASCQ。
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基线
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干预组和对照组在 3 个月随访时相对于基线的变化阶段变化
大体时间:3个月的跟进
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参与者锻炼模式的当前阶段将通过 PASCQ 的改编版本进行评估。
它是一个二元类型(是/否)问卷,包含四个项目。
参与者将用“是”或“否”回答关于他们的身体活动实践的每个问题。
根据这些回答,他们将通过评分算法分为五个不同的阶段。
参与者将被要求在开始干预 3 个月后回答中文版的 PASCQ。
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3个月的跟进
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干预组和对照组在 6 个月随访时相对于基线的变化阶段变化
大体时间:6个月的随访
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参与者锻炼模式的当前阶段将通过 PASCQ 的改编版本进行评估。
它是一个二元类型(是/否)问卷,包含四个项目。
参与者将用“是”或“否”回答关于他们的身体活动实践的每个问题。
根据这些回答,他们将通过评分算法分为五个不同的阶段。
参与者将被要求在开始干预后 6 个月回答中文版的 PASCQ。
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6个月的随访
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干预组和对照组之间在 9 个月的随访中相对于基线的变化阶段变化
大体时间:9个月的随访
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参与者锻炼模式的当前阶段将通过 PASCQ 的改编版本进行评估。
它是一个二元类型(是/否)问卷,包含四个项目。
参与者将用“是”或“否”回答关于他们的身体活动实践的每个问题。
根据这些回答,他们将通过评分算法分为五个不同的阶段。
参与者将被要求在开始干预后 9 个月回答中文版的 PASCQ。
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9个月的随访
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干预组和对照组在 12 个月的随访中相对于基线的变化阶段变化
大体时间:12个月的跟进
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参与者锻炼模式的当前阶段将通过 PASCQ 的改编版本进行评估。
它是一个二元类型(是/否)问卷,包含四个项目。
参与者将用“是”或“否”回答关于他们的身体活动实践的每个问题。
根据这些回答,他们将通过评分算法分为五个不同的阶段。
参与者将被要求在开始干预 12 个月后回答中文版的 PASCQ。
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12个月的跟进
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基线身体活动自我效能
大体时间:基线
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PA-SE 将用于衡量孩子们对参加各种适合年龄的体育活动的自信心。
PA-SE 包括五个项目,其中询问孩子们是否“不确定”、“有点确定”或“非常确定”他们可以做这样的事情,例如“在 15-20 分钟内不停地保持稳定的步伐”分钟。
分数越高表明自我效能感越高。
参与者将被要求在随机化之前回答中文版的 PA-SE。
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基线
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干预组和对照组在 3 个月的随访中体力活动自我效能自基线的变化
大体时间:3个月的跟进
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PA-SE 将用于衡量孩子们对参加各种适合年龄的体育活动的自信心。
PA-SE 包括五个项目,其中询问孩子们是否“不确定”、“有点确定”或“非常确定”他们可以做这样的事情,例如“在 15-20 分钟内不停地保持稳定的步伐”分钟。
分数越高表明自我效能感越高。
参与者将被要求在开始干预 3 个月后回答中文版的 PA-SE。
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3个月的跟进
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干预组和对照组在 6 个月的随访中体力活动自我效能自基线的变化
大体时间:6个月的随访
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PA-SE 将用于衡量孩子们对参加各种适合年龄的体育活动的自信心。
PA-SE 包括五个项目,其中询问孩子们是否“不确定”、“有点确定”或“非常确定”他们可以做这样的事情,例如“在 15-20 分钟内不停地保持稳定的步伐”分钟。
分数越高表明自我效能感越高。
参与者将被要求在开始干预后 6 个月回答中文版的 PA-SE。
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6个月的随访
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干预组和对照组在 9 个月的随访中体力活动自我效能自基线的变化
大体时间:9个月的随访
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PA-SE 将用于衡量孩子们对参加各种适合年龄的体育活动的自信心。
PA-SE 包括五个项目,其中询问孩子们是否“不确定”、“有点确定”或“非常确定”他们可以做这样的事情,例如“在 15-20 分钟内不停地保持稳定的步伐”分钟。
分数越高表明自我效能感越高。
干预开始后 9 个月,参与者将被要求回答中文版的 PA-SE。
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9个月的随访
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干预组和对照组在 12 个月的随访中体力活动自我效能自基线的变化
大体时间:12个月的跟进
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PA-SE 将用于衡量孩子们对参加各种适合年龄的体育活动的自信心。
PA-SE 包括五个项目,其中询问孩子们是否“不确定”、“有点确定”或“非常确定”他们可以做这样的事情,例如“在 15-20 分钟内不停地保持稳定的步伐”分钟。
分数越高表明自我效能感越高。
参与者将被要求在开始干预 12 个月后回答中文版的 PA-SE。
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12个月的跟进
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基线生活质量
大体时间:基线
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PedsQL 将用于衡量儿童癌症幸存者的生活质量。
该量表包括 23 个项目,分为四个分量表:身体机能(8 个项目)、情感功能(5 个项目)、社会功能(5 个项目)和学校功能(5 个项目)。
将询问参与者在过去一个月中经历了多少问题,评分从 0 到 4。分数越高表示生活质量越好。
参与者将被要求在随机化之前回答中文版的 PedsQL。
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基线
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干预组和对照组之间 3 个月随访时生活质量相对于基线的变化
大体时间:3个月的跟进
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PedsQL 将用于衡量儿童癌症幸存者的生活质量。
该量表包括 23 个项目,分为四个分量表:身体机能(8 个项目)、情感功能(5 个项目)、社会功能(5 个项目)和学校功能(5 个项目)。
将询问参与者在过去一个月中经历了多少问题,评分从 0 到 4。分数越高表示生活质量越好。
参与者将被要求在开始干预 3 个月后回答中文版的 PedsQL。
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3个月的跟进
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干预组和对照组之间 6 个月随访时生活质量相对于基线的变化
大体时间:6个月的随访
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PedsQL 将用于衡量儿童癌症幸存者的生活质量。
该量表包括 23 个项目,分为四个分量表:身体机能(8 个项目)、情感功能(5 个项目)、社会功能(5 个项目)和学校功能(5 个项目)。
将询问参与者在过去一个月中经历了多少问题,评分从 0 到 4。分数越高表示生活质量越好。
参与者将被要求在开始干预 6 个月后对中文版的 PedsQL 做出回应。
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6个月的随访
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干预组和对照组在 9 个月的随访中生活质量相对于基线的变化
大体时间:9个月的随访
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PedsQL 将用于衡量儿童癌症幸存者的生活质量。
该量表包括 23 个项目,分为四个分量表:身体机能(8 个项目)、情感功能(5 个项目)、社会功能(5 个项目)和学校功能(5 个项目)。
将询问参与者在过去一个月中经历了多少问题,评分从 0 到 4。分数越高表示生活质量越好。
参与者将被要求在开始干预 9 个月后对中文版的 PedsQL 做出回应。
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9个月的随访
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干预组和对照组在 12 个月的随访中生活质量相对于基线的变化
大体时间:12个月的跟进
|
PedsQL 将用于衡量儿童癌症幸存者的生活质量。
该量表包括 23 个项目,分为四个分量表:身体机能(8 个项目)、情感功能(5 个项目)、社会功能(5 个项目)和学校功能(5 个项目)。
将询问参与者在过去一个月中经历了多少问题,评分从 0 到 4。分数越高表示生活质量越好。
参与者将被要求在开始干预 12 个月后回答中文版的 PedsQL。
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12个月的跟进
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干预组和对照组之间 3 个月随访时肌肉力量相对于基线的变化
大体时间:3个月的跟进
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肌肉的等速肌力将在干预开始 3 个月后通过测力计使用休息和休息技术进行测量。
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3个月的跟进
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干预组和对照组之间 6 个月随访时肌肉力量相对于基线的变化
大体时间:6个月的随访
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在开始干预后 6 个月,肌肉的等速运动强度将通过使用休息和休息技术的测力计来测量。
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6个月的随访
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干预组和对照组之间 9 个月随访时肌肉力量相对于基线的变化
大体时间:9个月的随访
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在开始干预后 9 个月,肌肉的等速肌力将通过使用休息和休息技术的测力计来测量。
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9个月的随访
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干预组和对照组在 12 个月的随访中肌肉力量相对于基线的变化
大体时间:12个月的跟进
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在开始干预 12 个月后,肌肉的等速肌力将通过使用休息和休息技术的测力计进行测量。
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12个月的跟进
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change in physical activity levels from baseline at 3-month follow-up between intervention and control group
大体时间:3-month follow-up
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The physical activity levels of participants will be assessed using the CUHK-PARCY, which is an 11-item activity rating modified from the Jackson Activity Coding and the Godin-Shephard Activity Questionnaire Modified for Adolescents.
Participant will be asked to respond to the Chinese version of the CUHK-PARCY at 6 months after starting the intervention.
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3-month follow-up
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muscle strength at baseline
大体时间:baseline
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the isokinetic strength of muscles will be measured by a dynamometer using a break and make technique before randomization.
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baseline
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合作者和调查者
调查人员
- 首席研究员:William Ho Cheung Li, PhD、The School of Nursing, The University of Hong Kong
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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