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Effect of Weighted Blankets on Anxiety for Pediatric Oncology Patients

Primary Purpose

Pediatric Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weighted Blanket
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric Cancer

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed pediatric oncology patients between the ages of 4 and 17 receiving outpatient chemotherapy infusions in one of the two designated out patient locations (Anschutz Campus and Colorado Springs Hospital)
  • Patients who have a "liquid tumor" (leukemia or lymphoma), "solid tumor", or a neuro-oncologic diagnosis
  • Patients who can complete the CAM-S and CAM-T as proven by seriation screening.
  • Patients who are great than 13.5kg in weight, due to weighted blanket size options
  • Patients whose second and third outpatient chemotherapy occur within 30 days of each other.
  • English and Spanish speaking

Exclusion Criteria:

  • Patients who are younger than 4 years of age, or older than 17 years of age
  • Relapsed patients
  • Patients who are undergoing bone marrow transplant or had a previous bone marrow transplant
  • Patients receiving chemotherapy infusions at North Campus and South Campus locations
  • Patients in the inpatient setting
  • Patients who utilize a weighted blanket at home currently or previously
  • Patients who fail seriation screening during enrollment
  • Patients who start initial chemotherapy infusions in the outpatient setting

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

WB:UC

UC:WB

Arm Description

Weighted Blanket 2nd infusion Usual Care 3rd infusion

Usual Care 2nd infusion Weighted Blanket 3rd infusion

Outcomes

Primary Outcome Measures

Children's Anxiety Meter-State (CAM-S) assessment
The CAM-S is completed by showing the child a picture of a mercury thermometer and asking the child to "Pretend that all of your worried or nervous feelings are in the very bottom down here (point to scale). If you are a little bit worried or nervous, the feelings might come up just a little bit (move finger up). If you are very, very worried, or nervous, the feelings might come up just a little bit (move finger up to the top). Put a line showing how much worry or nervousness you feel right now." This scale is from measured from 1-10. Higher values indicate higher anxiety. The CAM-S will be administered during the following times: prior to infusion start, thirty minutes into the treatment or end of the treatment if <30 minutes and end of the treatment (see Figure 1).

Secondary Outcome Measures

Pediatric Quality of Life Inventory Generic Core Scales (Peds QL 4.0)
The Peds QL 4.0 is a 23-item questionnaire and is broken up into four sections: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). These questions are aimed to measure health-related quality of life in children and adolescents who are healthy and those with acute or chronic health conditions (Varni, Burwinkle, Seid & Skarr, 2003). We will utilize the parent-proxy questionnaires with responses measured on a 5-point response scale: 0 = never a problem; 1= almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. The scale is recoded and summarized to have a score ranging from 0 to 100 where higher values indicate higher quality of life.

Full Information

First Posted
September 7, 2021
Last Updated
August 9, 2023
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado
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1. Study Identification

Unique Protocol Identification Number
NCT05041075
Brief Title
Effect of Weighted Blankets on Anxiety for Pediatric Oncology Patients
Official Title
Effects of Weighted Blankets on Anxiety for Pediatric Oncology Patients During Outpatient Chemotherapy Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
August 9, 2023 (Actual)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The use of weighted blankets has been studied in the adult population but there is a lack of evidence to determine their benefit among a pediatric population, specifically oncology pediatric patients. Pediatric oncology patients routinely experience anxiety during therapy and as cure rates increase, attention has progressively turned to treating psychosocial aspects of care.
Detailed Description
A randomized 2x2 cross-over design will be utilized for this study. The study team will randomize participants to one of two sequences: 1) weighted blanket first then usual care or 2) usual care first then weighted blanket. The cross-over design allows the researchers to compare both within and between group differences. The advantages of the cross-over design allow minimize potential confounding bias as patients will serve as their own controls as well as potential for adequate power with smaller patient enrollment. As this study is conducted during chemotherapy treatments, the 30-day period in between patient treatments will be considered the washout period. This timeframe between chemotherapy infusions was chosen to try to capture patients in a similar state of baseline anxiety. This helps to provide adjustments to variability but should not limit accrual based on the number of patients that get chemotherapy within a 30-day period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WB:UC
Arm Type
Active Comparator
Arm Description
Weighted Blanket 2nd infusion Usual Care 3rd infusion
Arm Title
UC:WB
Arm Type
Active Comparator
Arm Description
Usual Care 2nd infusion Weighted Blanket 3rd infusion
Intervention Type
Device
Intervention Name(s)
Weighted Blanket
Intervention Description
Weighted blankets provide Deep Pressure Stimulation (DPS) or Deep Touch Pressure (DTP) which has advantages in both physical and psychological domains.
Primary Outcome Measure Information:
Title
Children's Anxiety Meter-State (CAM-S) assessment
Description
The CAM-S is completed by showing the child a picture of a mercury thermometer and asking the child to "Pretend that all of your worried or nervous feelings are in the very bottom down here (point to scale). If you are a little bit worried or nervous, the feelings might come up just a little bit (move finger up). If you are very, very worried, or nervous, the feelings might come up just a little bit (move finger up to the top). Put a line showing how much worry or nervousness you feel right now." This scale is from measured from 1-10. Higher values indicate higher anxiety. The CAM-S will be administered during the following times: prior to infusion start, thirty minutes into the treatment or end of the treatment if <30 minutes and end of the treatment (see Figure 1).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory Generic Core Scales (Peds QL 4.0)
Description
The Peds QL 4.0 is a 23-item questionnaire and is broken up into four sections: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). These questions are aimed to measure health-related quality of life in children and adolescents who are healthy and those with acute or chronic health conditions (Varni, Burwinkle, Seid & Skarr, 2003). We will utilize the parent-proxy questionnaires with responses measured on a 5-point response scale: 0 = never a problem; 1= almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. The scale is recoded and summarized to have a score ranging from 0 to 100 where higher values indicate higher quality of life.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Weighted Blanket Use
Description
Prior to discharge, a trained infusion nurse or a member of the weighed blanket research team will ask participants/families to classify if the participant used the blanket 0-20%, 20-40%, 40-60%, 60-80%, or 80-100% of their total infusion time.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed pediatric oncology patients between the ages of 4 and 17 receiving outpatient chemotherapy infusions in one of the two designated out patient locations (Anschutz Campus and Colorado Springs Hospital) Patients who have a "liquid tumor" (leukemia or lymphoma), "solid tumor", or a neuro-oncologic diagnosis Patients who can complete the CAM-S and CAM-T as proven by seriation screening. Patients who are great than 13.5kg in weight, due to weighted blanket size options Patients whose second and third outpatient chemotherapy occur within 30 days of each other. English and Spanish speaking Exclusion Criteria: Patients who are younger than 4 years of age, or older than 17 years of age Relapsed patients Patients who are undergoing bone marrow transplant or had a previous bone marrow transplant Patients receiving chemotherapy infusions at North Campus and South Campus locations Patients in the inpatient setting Patients who utilize a weighted blanket at home currently or previously Patients who fail seriation screening during enrollment Patients who start initial chemotherapy infusions in the outpatient setting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Olson
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Weighted Blankets on Anxiety for Pediatric Oncology Patients

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