Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy

Completed

• Conditions: Pediatric ALL; Radiotherapy Side Effect

• Registration Number: NCT02993978
• Lead Sponsor: Umeå University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-11
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-12-14
• Last Update Submitted: 2016-12-14
• Study First Posted: 2016-12-15
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Radiotherapy treatment

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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