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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Children's Anxiety Meter-State (CAM-S) assessment
Secondary outcome measures
Pediatric Quality of Life Inventory Generic Core Scales (Peds QL 4.0)
Other outcome measures
Weighted Blanket Use
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
1,732 Previous Clinical Trials
2,143,557 Total Patients Enrolled
Children's Hospital ColoradoOTHER
115 Previous Clinical Trials
5,127,589 Total Patients Enrolled
Jennifer OlsonPrincipal InvestigatorChildren's Hospital Colorado
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can speak English and Spanish.I am undergoing or have had a bone marrow transplant.I started my chemotherapy as an outpatient.I weigh more than 13.5kg.I am a child aged 4-17 with cancer, starting chemotherapy at specific hospitals.My second and third chemotherapy sessions were less than 30 days apart.I am either younger than 4 or older than 17 years old.My condition has worsened after initial improvement.I have leukemia, lymphoma, a solid tumor, or a brain/spinal cord cancer.I am currently hospitalized.
Research Study Groups:
This trial has the following groups:- Group 1: WB:UC
- Group 2: UC:WB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What demographic is best suited to be included in this medical experiment?
"This pediatric cancer study demands that participants are aged 4 to 17, and will take up to 120 patients."
Answered by AI
How many participants are currently included in this experiment?
"Affirmative. The information found on clinicaltrials.gov reflects that this research study, which was initially listed on January 10th 2022, is actively looking for participants. Approximately 120 individuals are needed to be recruited at 1 medical facility."
Answered by AI
Is this research project open to participants aged 70 or older?
"This clinical trial only considers applicants aged 4 to 17. There are 85 trials for minors and 82 trials for seniors who meet the requisite criteria."
Answered by AI
Is there currently a call for patients to join this clinical experiment?
"Affirmative. According to trials posted on clinicaltrials.gov, this medical experiment is currently recruiting individuals for its study cohort. It was initially published and subsequently revised on January 10th and 11th 2022 respectively; 120 patients are expected at a single location."
Answered by AI
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