Integrated Experiential Training Program With Coaching by Nursing Students in Childhood Cancer Patients
Condition: Child; Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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

      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. The activities during the home visits
      over a six-month period include playing cards or chess games, health advice on the prevention
      of influenza and healthy diet which will be conducted for 30 minutes.The participants will
      also receive a 30-minute English tutorial session with the research assistants in each home
      visit.

      To ensure the dosage of intervention delivered in terms of the amount, frequency, duration,
      and breadth would be adequate to assess physical activity levels, physical activity
      self-efficacy, cancer-related fatigue, depression, muscle strength, and quality of life, a
      research committee is crucial to assess the dosage of the intervention and to train the
      volunteer nursing students as coaches for the intervention. In particular, the safety and
      appropriateness of the intervention content were reviewed carefully by the committee before
      commencement. The members in the committee consist of an associate professor, an assistant
      professor and a research student from a local university who are equipped with extensive
      experience in conducting different research and particularly, psychosocial interventions for
      children with cancer. The committee also includes a professor in paediatric oncology and a
      specialist nurse with substantial experience in delivering care to children undergoing cancer
      treatment, and an assistant professor who is an expert specialising in sports and recreation
      management.

      Data Collection Methods

      Approval for the study was obtained from the hospital ethics committees. To identify
      potential subjects, the research student approach to eligible children and their parents
      after screening the medical records in a paediatric oncology ward of a public acute care
      hospital in Hong Kong. After explaining the study details, including its purpose, procedures
      and potential harms and benefits, parents allowing their children to take part are required
      to sign a consent form. In addition, the children who are going to participate are invited to
      write down their names on a specially designed child assent form and told that their
      participation is voluntary.

      Data collection for the outcome variables is conducted at the time of the subject recruitment
      (T1), and six (T2), and nine (T3) months after the start of the intervention, except that
      physical activity levels of childhood cancer patients are collected at the time of the
      subject recruitment (T1), and nine (T2) months after the start of the intervention. Before
      randomisation, participants are required to complete the hand grip strength test with the
      hand-held dynamometers (HHD) and fill in a set of questionnaires including CUHK-PARCY, the
      Chinese versions of PA-SE, fatigue scale, CES-DC, and PedsQL cancer module. Semi-structured
      interviews will also be carried out.

      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) and post-hoc analysis using the Tukey procedure will be used to
      determine whether the integrated experiential training program with coaching by nursing
      students was effective in reducing fatigue, increasing childhood cancer patients' levels of
      physical activity, self-efficacy and muscle strength, decreasing depressive symptoms and
      enhancing their quality of life. Descriptive phenomenology will be employed during the
      process of qualitative data analysis.
    

Intervention name(s): an integrated experiential training program with coaching; Placebo Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will be implemented to each participant by a designated coach who is a trained nursing student during 28 home visits throughout a 6-month period (24 weeks) and each visit will last 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 will pay a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. 4 levels of physical activity will be taught to the participants gradually according to their ability.; 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. The placebo activities during the home visits may include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care