Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy

NCT ID: NCT02993978

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric ALL Radiotherapy Side Effect

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pediatric radiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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..

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Radiotherapy treatment

Exclusion Criteria

\-
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Umeå University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27055258 (View on PubMed)

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.

Reference Type RESULT
PMID: 26509449 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29357940 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-113-31M

Identifier Type: -

Identifier Source: org_study_id