Malignant Childhood Neoplasm Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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