<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02993978</url>
  </required_header>
  <id_info>
    <org_study_id>2012-113-31M</org_study_id>
    <nct_id>NCT02993978</nct_id>
  </id_info>
  <brief_title>Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy</brief_title>
  <acronym>DUMBO</acronym>
  <official_title>Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umeå University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the effect of changes in the care environment in&#xD;
      pediatric radiotherapy. The definitions of the changes is a part of the study, and is&#xD;
      constructed in collaboration with the institute of design at Umeå University. The&#xD;
      implementation is however not part of the study, but done as part of Clinical routine.&#xD;
&#xD;
      The study consist of two parts, where the first 1.5 years are a Control phase where the&#xD;
      changes are designed and also function as a baseline period. The following 1.5 years are the&#xD;
      case period where the Changes that are accepted for Clinical implementation are implemented.&#xD;
&#xD;
      The impact of the changes are evaluated using surveys and interviews of both parents and&#xD;
      children&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to evaluate the effect of changes in the care environment in&#xD;
      pediatric radiotherapy. The definitions of the changes is a part of the study, and is&#xD;
      constructed in collaboration with the institute of design at Umeå University. The&#xD;
      implementation is however not part of the study, but done as part of Clinical routine.&#xD;
&#xD;
      The study consist of two parts, where the first 1.5 years are a Control phase where the&#xD;
      changes are designed and also function as a baseline period. The following 1.5 years are the&#xD;
      case period where the Changes that are accepted for Clinical implementation are implemented.&#xD;
&#xD;
      The impact of the changes are evaluated using surveys and interviews of both parents and&#xD;
      children. Interviews of the personnel regarding their experiences of the study and the&#xD;
      changes is performed after the finalization of the case period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Parents anxiety during treatment period</measure>
    <time_frame>1 day</time_frame>
    <description>VAS-anxiety scoring in connection to therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Childrens anxiety during treatment period</measure>
    <time_frame>1 day</time_frame>
    <description>FAS-evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parents quality of Life during treatment period</measure>
    <time_frame>1 day</time_frame>
    <description>PedsQL survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parents view of the care and care environment</measure>
    <time_frame>After treatment period (within 2 months after last treatment)</time_frame>
    <description>Semi structured interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Childrens reflections regarding the treatment period</measure>
    <time_frame>After treatment period (within 2 months after last treatment)</time_frame>
    <description>Semi structured interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of sedative treatment in connection to radiotherapy</measure>
    <time_frame>up to 2 months</time_frame>
    <description>The use of sedative treatments were recorded for each fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiences of the personnel</measure>
    <time_frame>After the case period (within 1 year)</time_frame>
    <description>Interviews</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">57</enrollment>
  <condition>Pediatric ALL</condition>
  <condition>Radiotherapy Side Effect</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <description>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..</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All pediatric patients treated with radiotherapy at the study centres were candidates for&#xD;
        the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Radiotherapy treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>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.</citation>
    <PMID>27055258</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>26509449</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatric radiotherapy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02993978
org study id: 2012-113-31M
nct id: NCT02993978
lead sponsor: 
has dmc: No
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
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.
observational model: Case-Control
time perspective: Prospective
measure: Parents anxiety during treatment period
time frame: 1 day
description: VAS-anxiety scoring in connection to therapy
measure: Childrens anxiety during treatment period
time frame: 1 day
description: FAS-evaluation
measure: Parents quality of Life during treatment period
time frame: 1 day
description: PedsQL survey
measure: Parents view of the care and care environment
time frame: After treatment period (within 2 months after last treatment)
description: Semi structured interview
measure: Childrens reflections regarding the treatment period
time frame: After treatment period (within 2 months after last treatment)
description: Semi structured interview
measure: Use of sedative treatment in connection to radiotherapy
time frame: up to 2 months
description: The use of sedative treatments were recorded for each fraction
measure: Experiences of the personnel
time frame: After the case period (within 1 year)
description: Interviews
arm group label: Control group
description: 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.
arm group label: Case group
description: 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..
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
citation: 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.
PMID: 27055258
citation: 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.
PMID: 26509449
responsible party type: Sponsor
sharing ipd: No