Intervention of a Game About Radiotherapy for Children With Cancer

NCT04728555 | Completed

• 1 other identifier: Children's RT Game 21-22
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety State

Keywords

Children, cancer, psychosocial support, serious game

Outcome Measures

Primary Outcomes (1)

• Children's State anxiety, change is being assessed

  From the questionnaire STAI-C1

  Baseline and on treatment day three, six and 15

Secondary Outcomes (3)

• Children's Trait anxiety

  Baseline

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

  Baseline and on treatment day three

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

  One week after the intervention

Other Outcomes (1)

• Parent's State and Trait anxiety

  Baseline

Study Arms (2)

Game before RT start

EXPERIMENTAL

Intervention of a digital game five days before start of RadioTherapy

Procedure: Game about radiotherapy

Game after RT start

EXPERIMENTAL

Intervention of a digital game three days after start of RadioTherapy

Procedure: Game about radiotherapy

Interventions

Game about radiotherapy PROCEDURE

A digital pedagogical game about radiotherapy

Game after RT start; Game before RT start

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead
• Umeå University: collaborator

Study Sites (1)

Department of Women's and Children's Health

Uppsala, SE-75185, Sweden

Location

Related Publications (2)

• 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.

  PMID: 35639467 BACKGROUND

• 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.

  PMID: 36327521 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Gunn Engvall, Professor

  Women's and Children's Health, Uppsala University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non-blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor

Model Details: A non-blinded randomized waiting list control study

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 28, 2021
• Study Start: March 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)