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Completed

NCT Number: NCT04728555

Intervention of a Game About Radiotherapy for Children With Cancer

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.

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Key information

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Women's and Children's Health

Uppsala, SE-75185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children aged 5-14 years old who are going to have radiotherapy at the Skandion Clinic, Uppsala with or without sedation/anesthesia, understand and can speak Swedish and have access to a computer.

Exclusion criteria

Severe cognitive impairment and too seriously ill to be able to answer questions.

Treatment and study plan

Game about radiotherapy

Procedure

A digital pedagogical game about radiotherapy

Primary outcomes

  1. Children's State anxiety, change is being assessed

    Time frame: Baseline and on treatment day three, six and 15

    From the questionnaire STAI-C1

Secondary outcomes

  1. Children's Trait anxiety

    Time frame: Baseline

    From the questionnaire STAI-C2

  2. Children's self-efficacy to remain motionless, change is being assessed

    Time frame: Baseline and on treatment day three

    From a questionnaire made for the study

  3. Children's perception of the digital game about radiotherapy: usability and engagement

    Time frame: One week after the intervention

    From the questionnaire PENS

Other outcomes

  1. Parent's State and Trait anxiety

    Time frame: Baseline

    From the questionnaire STAI-Y1 and STAI-Y2

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Umeå University

Registry information

Official study title

Evaluation of an Intervention by a Pedagogical Digital Game About Radiotherapy for Children With Cancer

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2021
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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