Clinical trial NCT05041075: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2021-09-10
Enrollment: 26
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Children's Anxiety Meter-State (CAM-S) assessment
timeFrame: 12 months
Secondary outcomes:
measure: Pediatric Quality of Life Inventory Generic Core Scales (Peds QL 4.0)
timeFrame: 12 months
Other outcomes:
measure: Weighted Blanket Use
timeFrame: 12 months
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Jennifer Olson
role: PRINCIPAL_INVESTIGATOR
References: