Intervention of a Game About Radiotherapy for Children With Cancer
Condition: Anxiety State
Study type: Interventional

Summary: 
      Background: Radiotherapy (RT) can be stressful and challenging for children exposed to a
      highly technical environment with large radiation equipment and immobilization devices. A
      pedagogical digital game about RT has been developed. Children who have received RT
      participated in work-shops and contributed with their experiences and suggestions.

      Aim: To explore whether the intervention with a pedagogical digital game facilitate
      understanding, choice of distraction, creation of a sense of calmness and self-efficacy prior
      to and during RT and to describe the children's and the parents experiences and use of the
      game as a pedagogical tool. Further, to investigate feasibility in terms of reach, usability
      and acceptability.

      Method: A feasibility and prospective waiting list control design is planned by recruiting 60
      children (5-14 years) and their parents, for randomization into two groups. The first group
      will receive the game five days before start of RT. All children will have standard
      information one day before RT. The second group will have access to the game three days after
      start of treatment. The effects of the game will be investigated before and during RT and
      between groups as they receive the game at different time. Children will answer
      questionnaires about self-assessed anxiety, understanding of the procedure, distraction
      strategies, self-efficacy to remain motionless. Statistical comparative and correlational
      analyses will be calculated. Interviews will be performed with 12 children and 24 parents.
      Changes and further development of the game will be implemented based on the results of the
      responses.

      Significance: The game can support children to undergo RT and be used nationally to prepare
      for RT. Thus all children receive similar information regardless of where they live, and
      contribute to increased knowledge, autonomy, reduce fear and anxiety. In the long term, the
      use of anesthesia could decrease for children.
    

Detailed description: 
      Data Collection and procedure:

      Access to the game for children randomized to the first group: Four to six days before start
      of treatment.

      Questionnaires to all children: Questions about state and trait anxiety, and radiotherapy
      before the information meeting with the oncology nurse, one day before the start of
      treatment, at baseline.

      Questionnaire to parents: Questions about state and trait anxiety before the information
      meeting with the oncology nurse at baseline.

      Information meeting with all children and their parents: Information about radiotherapy by
      oncology nurse at baseline Questionnaires to all children: Questions about state anxiety and
      radiotherapy on treatment day one and three.

      Access to the game for children randomized to the second group: Day three after start of
      treatment.

      Questionnaire to all children: Questions about state anxiety on treatment day six and 15.

      Questionnaire to all children: Questions about the digital game one week after access to the
      game.

      Game logs: Collection of game logs one week after the intervention.

      Interview of 12 children and 24 parents: Within four weeks after end of treatment.

      Power: A power of 0.80, an alpha value of 0.05 and a size-effect of 0.5 provided an
      estimation of 26 participants in each group. Thirty participants are planned in case of
      dropouts.

      Data analysis: Comparative and correlational statistical analyses.
    

Intervention name(s): Game about radiotherapy
Intervention type(s): Procedure
Intervention description(s): A digital pedagogical game about radiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A non-blinded randomized waiting list control study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Children, cancer, psychosocial support, serious game