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Trial record 1 of 1 for:    NCT02993978
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Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy (DUMBO)

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ClinicalTrials.gov Identifier: NCT02993978
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy
Study Start Date : August 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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..



Primary Outcome Measures :
  1. Parents anxiety during treatment period [ Time Frame: 1 day ]
    VAS-anxiety scoring in connection to therapy

  2. Childrens anxiety during treatment period [ Time Frame: 1 day ]
    FAS-evaluation

  3. Parents quality of Life during treatment period [ Time Frame: 1 day ]
    PedsQL survey

  4. Parents view of the care and care environment [ Time Frame: After treatment period (within 2 months after last treatment) ]
    Semi structured interview

  5. Childrens reflections regarding the treatment period [ Time Frame: After treatment period (within 2 months after last treatment) ]
    Semi structured interview


Secondary Outcome Measures :
  1. Use of sedative treatment in connection to radiotherapy [ Time Frame: up to 2 months ]
    The use of sedative treatments were recorded for each fraction

  2. Experiences of the personnel [ Time Frame: After the case period (within 1 year) ]
    Interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All pediatric patients treated with radiotherapy at the study centres were candidates for the study.
Criteria

Inclusion Criteria:

  • Radiotherapy treatment

Exclusion Criteria:

-

Publications of Results:
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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT02993978    
Other Study ID Numbers: 2012-113-31M
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Umeå University:
Pediatric radiotherapy