Effectiveness of an Integrated Experiential Training Program With Coaching by Nursing Students in Promoting Regular Physical Activity and Reducing Fatigue Among Childhood Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in levels of cancer-related fatigue from baseline at 9 month follow-up between intervention and control group
研究概览
简要总结
Background: Despite the evidence that regular physical activity can have beneficial effects on the physical and psychological well-being of cancer patients, a review of the literature reveals that a majority of young cancer patients fail to attain the same levels of physical activity that they had before contracting the disease. There is scientific evidence that physical inactivity induces muscle catabolism and atrophy and cardiovascular diseases, which may lead to a further increase in fatigue and a decrease in the functional capacity of cancer patients. Empirical evidence is needed to explore an appropriate strategy for promoting physical activity in such patients.
Purposes: To examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.
Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated post-test, within and between subjects design will be conducted. Recruitment of subjects will be carried out in a paediatric oncology ward of a Hong Kong acute care hospital.
Intervention: Participants in the experimental group will join an integrated experiential training program with coaching by nursing students, which contains 28 home visits by a designated nursing student as a coach for a 6-month period. Those in the placebo control group will receive an amount of time and attention (home visits by research assistants) that mimics that received by the experimental group.
详细描述
The aim of this study is to examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.
Intervention
Experimental group
During hospitalization for cancer treatment, besides receiving usual care, a registered nurse will deliver participants a health education talk. Participants will then be taught and encouraged to practice some simple stretching and relaxing exercises. After discharged from the hospital, participants in the experimental group are scheduled to take part in an integrated experiential training program with coaching by nursing students. Each participant is allocated to a nursing student who was voluntarily trained as coaches for the program. The intervention is implemented to each participant by the designated coach during 28 home visits throughout a 6-month period (24 weeks) and each visit lasts for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach pays a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. During the individual coaching sessions with the young people, the coaches will teach and demonstrate physical activities in 4 levels to the participants according to participants' ability.
Placebo control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 9 to 18
- •diagnosed with cancer at some time in the previous month and currently undergoing active treatments
- •able to speak Cantonese and read Chinese
排除标准
- •evidence of recurrence or second malignancies
- •physical impairment or cognitive or learning problems identified from their medical records
研究组 & 干预措施
Experimental group
During hospitalization for cancer treatment, besides receiving usual care, participants in the experimental group will first receive a health education talk Participants will then be taught and encouraged to practice with some stretching and relaxing exercises during their hospitalization. After hospitalization, participants will receive an integrated experiential training program with coaching by nursing students through home visits.
干预措施: an integrated experiential training program with coaching (Behavioral)
Placebo Control group
Since participants in both groups are hospitalized in the same unit, to avoid contamination, participants in the placebo control group will receive the same intervention as those participants in the experimental group during their hospitalization. When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures.
干预措施: Placebo Control (Behavioral)
结局指标
主要结局
Change in levels of cancer-related fatigue from baseline at 9 month follow-up between intervention and control group
时间窗: 9 month follow-up
The primary outcomes are levels of cancer-related fatigue at 9 months after starting the intervention. The Chinese version of Fatigue Scale will be used to assess the fatigue of subjects.
次要结局
- Change in depressive symptoms from baseline at 6 month follow-up(6 month follow-up)
- Change in levels of quality of life from baseline at 9 month follow-up between intervention and control group(9 month follow-up)
- Change in levels of physical activity from baseline at 9 month follow-up between intervention and control group(9 month follow-up)
- Levels of cancer-related fatigue at baseline(baseline)
- Change in cancer-related fatigue from baseline at 6 month follow-up between intervention and control group(6 month follow-up)
- Depressive symptoms at baseline(baseline)
- Levels of quality of life at baseline(baseline)
- Change in levels of physical activity self-efficacy from baseline at 6 month follow-up(6 month follow-up)
- Muscle strength at baseline(basline)
- Change in levels of quality of life from baseline at 6 month follow-up between intervention and control group(6 month follow-up)
- Levels of physical activity at baseline(baseline)
- Levels of physical activity self-efficacy at baseline(baseline)
- Change in levels of physical activity self-efficacy from baseline at 9 month follow-up(9 month follow-up)
- Change in depressive symptoms from baseline at 9 month follow-up(9 month follow-up)
- Change in muscle strength from baseline at 6 month follow-up between intervention and control group(6 month follow-up)
- Change in muscle strength from baseline at 9 month follow-up between intervention and control group(9 month follow-up)