Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy (DUMBO)

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

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Radiotherapy Side Effect

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 Type: Observational
• Enrollment (Actual): 57

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All pediatric patients treated with radiotherapy at the study centres were candidates for the study.

Description

Inclusion Criteria:

• Radiotherapy treatment

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group; 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; 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?

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)

Collaborators and Investigators

• Sponsor: Umeå University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Pediatric radiotherapy
• Other Study ID Numbers: 2012-113-31M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO