Intervention of a Game About Radiotherapy for Children With Cancer

Evaluation of an Intervention by a Pedagogical Digital 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.

Study Overview

• Status: Completed
• Conditions: Anxiety State
• Intervention / Treatment: Procedure: Game about radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, SE-75185
    • Department of Women's and Children's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Game before RT start; Intervention of a digital game five days before start of RadioTherapy	Procedure: Game about radiotherapy; A digital pedagogical game about radiotherapy
Experimental: Game after RT start; Intervention of a digital game three days after start of RadioTherapy	Procedure: Game about radiotherapy; A digital pedagogical game about radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's State anxiety, change is being assessed	From the questionnaire STAI-C1	Baseline and on treatment day three, six and 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Trait anxiety	From the questionnaire STAI-C2	Baseline
Children's self-efficacy to remain motionless, change is being assessed	From a questionnaire made for the study	Baseline and on treatment day three
Children's perception of the digital game about radiotherapy: usability and engagement	From the questionnaire PENS	One week after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent's State and Trait anxiety	From the questionnaire STAI-Y1 and STAI-Y2	Baseline

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Umeå University

Publications and helpful links

General Publications

• Cederved C, Back J, Angstrom-Brannstrom C, Ljungman G, Engvall G. Co-creation of a Serious Game About Radiotherapy: Participatory Action Research Study With Children Treated for Cancer. JMIR Hum Factors. 2022 May 31;9(2):e34476. doi: 10.2196/34476.
• Cederved C, Angstrom-Brannstrom C, Ljungman G, Engvall G. Parents' experiences of having their children take part in participatory action research creating a serious game about radiotherapy. Radiography (Lond). 2023 Jan;29(1):95-100. doi: 10.1016/j.radi.2022.10.005. Epub 2022 Oct 29.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Children, cancer, psychosocial support, serious game
• Other Study ID Numbers: Children's RT Game 21-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be reported in scientific journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No