Clinical trial NCT02993978: Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy
Official title: Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Radiotherapy Side Effect
Keywords: Pediatric radiotherapy
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 57
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pediatric patients treated with radiotherapy at the study centres were candidates for the study.

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.

Eligibility criteria: Inclusion Criteria:

* Radiotherapy treatment

Exclusion Criteria:

-

Primary outcomes:
measure: Parents anxiety during treatment period
timeFrame: 1 day
measure: Childrens anxiety during treatment period
timeFrame: 1 day
measure: Parents quality of Life during treatment period
timeFrame: 1 day
measure: Parents view of the care and care environment
timeFrame: After treatment period (within 2 months after last treatment)
measure: Childrens reflections regarding the treatment period
timeFrame: After treatment period (within 2 months after last treatment)
Secondary outcomes:
measure: Use of sedative treatment in connection to radiotherapy
timeFrame: up to 2 months
measure: Experiences of the personnel
timeFrame: After the case period (within 1 year)
Other outcomes:
Locations:
Study officials:
References:
citation: Engvall G, Angstrom-Brannstrom C, Mullaney T, Nilsson K, Wickart-Johansson G, Svard AM, Nyholm T, Lindh J, Lindh V. It Is Tough and Tiring but It Works--Children's Experiences of Undergoing Radiotherapy. PLoS One. 2016 Apr 7;11(4):e0153029. doi: 10.1371/journal.pone.0153029. eCollection 2016.
citation: Angstrom-Brannstrom C, Engvall G, Mullaney T, Nilsson K, Wickart-Johansson G, Svard AM, Nyholm T, Lindh J, Lindh V. Children Undergoing Radiotherapy: Swedish Parents' Experiences and Suggestions for Improvement. PLoS One. 2015 Oct 28;10(10):e0141086. doi: 10.1371/journal.pone.0141086. eCollection 2015.