Intervention of a Game About Radiotherapy for Children With Cancer

Anxiety State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04728555
• Other study ID #: Children's RT Game 21-22
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety State

Intervention

Procedure:
• Game about radiotherapy
A digital pedagogical game about radiotherapy

Locations

Country	Name	City	State
Sweden	Department of Women's and Children's Health	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parent's State and Trait anxiety	From the questionnaire STAI-Y1 and STAI-Y2	Baseline
Primary	Children's State anxiety, change is being assessed	From the questionnaire STAI-C1	Baseline and on treatment day three, six and 15
Secondary	Children's Trait anxiety	From the questionnaire STAI-C2	Baseline
Secondary	Children's self-efficacy to remain motionless, change is being assessed	From a questionnaire made for the study	Baseline and on treatment day three
Secondary	Children's perception of the digital game about radiotherapy: usability and engagement	From the questionnaire PENS	One week after the intervention