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Completed

NCT Number: NCT02993978

Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy

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

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Key information

Conditions

Pediatric ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Radiation Injuries Radiotherapy Side Effect Wounds and Injuries

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Radiotherapy treatment

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Acronym: DUMBO

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 15, 2016
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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