Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect of changes in the care environment in pediatric radiotherapy. The definitions of the changes is a part of the study, and is constructed in collaboration with the institute of design at Umeå University. The implementation is however not part of the study, but done as part of Clinical routine. The study consist of two parts, where the first 1.5 years are a Control phase where the changes are designed and also function as a baseline period. The following 1.5 years are the case period where the Changes that are accepted for Clinical implementation are implemented. The impact of the changes are evaluated using surveys and interviews of both parents and children

Detailed Description
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The purpose of the study is to evaluate the effect of changes in the care environment in pediatric radiotherapy. The definitions of the changes is a part of the study, and is constructed in collaboration with the institute of design at Umeå University. The implementation is however not part of the study, but done as part of Clinical routine. The study consist of two parts, where the first 1.5 years are a Control phase where the changes are designed and also function as a baseline period. The following 1.5 years are the case period where the Changes that are accepted for Clinical implementation are implemented. The impact of the changes are evaluated using surveys and interviews of both parents and children. Interviews of the personnel regarding their experiences of the study and the changes is performed after the finalization of the case period.

Official Title
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Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy

Conditions
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Pediatric ALL, Radiotherapy Side Effect

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiotherapy treatment Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Pediatric patients and their parents who were treated with radiotherapy during baseline period and enrolled in the study. Recruitment to the Control Group took Place during one year. | |
| Case group<br>Pediatric patients and their parents who were treated with radiotherapy during case period and enrolled in the study. Recruitment to the case group took place during one year after introduction of new methods and equipment in the in the clinic.. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents anxiety during treatment period | VAS-anxiety scoring in connection to therapy | 1 day | 
| Childrens anxiety during treatment period | FAS-evaluation | 1 day | 
| Parents quality of Life during treatment period | PedsQL survey | 1 day | 
| Parents view of the care and care environment | Semi structured interview | After treatment period (within 2 months after last treatment) | 
| Childrens reflections regarding the treatment period | Semi structured interview | After treatment period (within 2 months after last treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of sedative treatment in connection to radiotherapy | The use of sedative treatments were recorded for each fraction | up to 2 months | 
| Experiences of the personnel | Interviews | After the case period (within 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric radiotherapy