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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02993978
Other study ID # 2012-113-31M
Secondary ID
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 UmeƄ 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


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
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