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CompletedNCT02993978DUMBOUpdated Dec 15, 2016

Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy

An observational study in Pediatric ALL and Radiotherapy Side Effect, sponsored by Umeå University. Completed. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-12-15.

Sponsored by Umeå University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
57
Ages
2 Years to 18 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Pediatric ALL
  • Radiotherapy Side Effect

Keywords

  • Pediatric radiotherapy
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.

This study's enrollment of 57 is below the median of 120 across 313 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Umeå University is the lead sponsor of 271 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Radiotherapy treatment

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
57 participants (actual)
Patient registry
No

Groups and cohorts

  • 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..

06

What researchers measure

Primary outcomes

  1. Parents anxiety during treatment period

    VAS-anxiety scoring in connection to therapy

    Time frame: 1 day

  2. Childrens anxiety during treatment period

    FAS-evaluation

    Time frame: 1 day

  3. Parents quality of Life during treatment period

    PedsQL survey

    Time frame: 1 day

  4. Parents view of the care and care environment

    Semi structured interview

    Time frame: After treatment period (within 2 months after last treatment)

  5. Childrens reflections regarding the treatment period

    Semi structured interview

    Time frame: After treatment period (within 2 months after last treatment)

Secondary outcomes

  1. Use of sedative treatment in connection to radiotherapy

    The use of sedative treatments were recorded for each fraction

    Time frame: up to 2 months

  2. Experiences of the personnel

    Interviews

    Time frame: After the case period (within 1 year)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 27055258 ↗
  • 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. PubMed 26509449 ↗
  • Engvall G, Lindh V, Mullaney T, Nyholm T, Lindh J, Angstrom-Brannstrom C. Children's experiences and responses towards an intervention for psychological preparation for radiotherapy. Radiat Oncol. 2018 Jan 22;13(1):9. doi: 10.1186/s13014-017-0942-5. PubMed 29357940 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02993978
Lead sponsor
Umeå University
Responsible party
Sponsor
First posted
Dec 15, 2016
Start date
Aug 2012
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Dec 15, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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