Effectiveness of an Adventure-based Training Programme to Reduce Fatigue for Childhood Cancer Survivors
Condition: Childhood Cancer
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Background: Cancer-related fatigue is the most common concern reported by Childhood cancer
      survivors. Empirical evidence is needed to find out an appropriate strategy for ameliorating
      its impact.

      Purposes: To examine the effectiveness of an adventure-based training programme in promoting
      regular physical activity, reducing fatigue and enhancing 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 has been conducted. Recruitment of subjects has been
      carried out in an outpatient clinic, and through the Children's Cancer Foundation and
      Sunshine Group, which are non-profit voluntary organizations with the aim to provide
      education and supportive services to parents of Hong Kong Chinese childhood cancer survivors.

      Intervention: Participants in the experimental group have joined a four-day adventure-based
      training programme, which contains education talks, a workshop and adventure-based training
      activities. Those in the placebo control group has received an amount of time and attention
      (leisure activities organized by a community centre) that mimick that received by the
      experimental group.
    

Detailed description: 
      The aim of this study is to examine the effectiveness of an adventure-based training
      programme in promoting regular physical activity, reducing fatigue and enhancing quality of
      life among Hong Kong Chinese childhood cancer survivors.

      Intervention

      Experimental group

      Besides receiving medical follow-up, participants have joined a four-day adventure-based
      training 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 is tailor-made for participants in which they do not
      engage in regular physical activity.

      Placebo control group

      Participants will receive medical follow-up according to the schedule of the oncology units.
      Besides, participants will receive an amount of time and attention that mimic 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 include cartoon film shows,
      handicraft workshops, chess games, health talks on the prevention of influenza and healthy
      diet, day visit to museums and theme parks and galleries.

      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
      has been taken. An advisory committee has been set up with the purpose to develop an
      appropriate programme for Hong Kong Chinese childhood cancer survivors. The committee
      includes an associate professor, a lecturer and a research student 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 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 has been sent to a professional adventure-based training centre for content
      validation. The programme has been 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 has been implemented in small group with maximum 12 participants
      in one group. Health education talks and workshop have been implemented in between
      adventure-based training activities in day camp centre, conducted by healthcare professionals
      working in a local university. Adventure-based training activities have been 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 join 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

      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 Group and Children's
      Cancer Foundation. 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 21.0 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.
    

Intervention name(s): health talk and adventure-based training; Placebo Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): To develop an integrated programme for Hong Kong Chinese childhood cancer survivors, an advisory committee was set up which included an associate professor, an assistant professor and a research student at a local university, a pediatric oncologist and oncology nurse 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 survivors.; 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 museums and theme parks and galleries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care