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Weighted Blankets for Pediatric Cancer Anxiety

N/A
Waitlist Available
Led By Jennifer Olson
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed pediatric oncology patients between the ages of 4 and 17 receiving outpatient chemotherapy infusions in designated locations (Anschutz Campus and Colorado Springs Hospital)
Patients with a 'liquid tumor' (leukemia or lymphoma), 'solid tumor', or a neuro-oncologic diagnosis
Must not have
Patients undergoing bone marrow transplant or had a previous bone marrow transplant
Patients who start initial chemotherapy infusions in the outpatient setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial found that among pediatric cancer patients, the use of a weighted blanket may help to decrease anxiety during treatment.

Who is the study for?
This trial is for pediatric oncology patients aged 4-17, who weigh over 13.5kg and are receiving outpatient chemotherapy at specific locations. It's for those with leukemia, lymphoma, solid tumors or neuro-oncologic diagnoses who haven't used weighted blankets before and can complete certain assessments in English or Spanish.
What is being tested?
The study is testing if using weighted blankets reduces anxiety in children with cancer during their therapy sessions. The focus is on kids getting outpatient chemo treatments to see how these blankets might improve their mental well-being.
What are the potential side effects?
Since the intervention involves non-medical items (weighted blankets), there are no direct medical side effects expected from this trial. However, comfort levels may vary individually when using the blanket.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a child aged 4-17 with cancer, starting chemotherapy at specific hospitals.
Select...
I have leukemia, lymphoma, a solid tumor, or a brain/spinal cord cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am undergoing or have had a bone marrow transplant.
Select...
I started my chemotherapy as an outpatient.
Select...
I am either younger than 4 or older than 17 years old.
Select...
My condition has worsened after initial improvement.
Select...
I am currently hospitalized.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Children's Anxiety Meter-State (CAM-S) assessment
Secondary study objectives
Pediatric Quality of Life Inventory Generic Core Scales (Peds QL 4.0)
Other study objectives
Weighted Blanket Use

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: WB:UCActive Control1 Intervention
Weighted Blanket 2nd infusion Usual Care 3rd infusion
Group II: UC:WBActive Control1 Intervention
Usual Care 2nd infusion Weighted Blanket 3rd infusion

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,802 Previous Clinical Trials
2,822,086 Total Patients Enrolled
Children's Hospital ColoradoOTHER
119 Previous Clinical Trials
5,132,815 Total Patients Enrolled
Jennifer OlsonPrincipal InvestigatorChildren's Hospital Colorado

Media Library

WB:UC Clinical Trial Eligibility Overview. Trial Name: NCT05041075 — N/A
Pediatric Cancer Research Study Groups: WB:UC, UC:WB
Pediatric Cancer Clinical Trial 2023: WB:UC Highlights & Side Effects. Trial Name: NCT05041075 — N/A
WB:UC 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041075 — N/A
~7 spots leftby Nov 2025
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