Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy

Pediatric ALL Clinical Trial

— DUMBO  

Official title:

Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993978
• Other study ID #: 2012-113-31M
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2016
• Last updated: December 14, 2016
• Start date: August 2012
• Est. completion date: August 2015

Study information

• Verified date: November 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Radiotherapy treatment

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pediatric ALL
• Radiotherapy Side Effect

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

References & Publications (2)

Ångström-Brännström C, Engvall G, Mullaney T, Nilsson K, Wickart-Johansson G, Svärd 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: — View Citation

Engvall G, Ångström-Brännström C, Mullaney T, Nilsson K, Wickart-Johansson G, Svärd 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/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parents anxiety during treatment period	VAS-anxiety scoring in connection to therapy	1 day	No
Primary	Childrens anxiety during treatment period	FAS-evaluation	1 day	No
Primary	Parents quality of Life during treatment period	PedsQL survey	1 day	No
Primary	Parents view of the care and care environment	Semi structured interview	After treatment period (within 2 months after last treatment)	No
Primary	Childrens reflections regarding the treatment period	Semi structured interview	After treatment period (within 2 months after last treatment)	No
Secondary	Use of sedative treatment in connection to radiotherapy	The use of sedative treatments were recorded for each fraction	up to 2 months	No
Secondary	Experiences of the personnel	Interviews	After the case period (within 1 year)	No