Clinical trial NCT06584955: Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients with Hematological Malignancies
Official title: Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients with Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematological Malignancies
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Gabrielles Angel FDN for Cancer Research
First posted: 2024-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers. Weighted blankets are heavier blankets that contain inner weight beads. The deep pressure stimulation induced by these blankets can have a calming effect.

Detailed description: Primary Objective:

To determine the feasibility of using weighted blankets to improve Sleep Disturbances (SD) for patients with hematological malignancies in an outpatient setting.

Secondary Objectives:

To explore if weighted blanket use improves sleep as assessed by the ESAS sleep question. A positive response is defined by at least a one-point reduction in ESAS sleep between baseline and day 7 +/-2 days.

To explore if weighted blanket use during a 14-day period improves Insomnia Severity Index (ISI) score.

To explore the response rate in anxiety, where response is defined as a minimum of one-point change in the ESAS anxiety score, between baseline and day 7 +/-2 days after the use of weighted blankets.

To explore if patients are satisfied with the use of weighted blankets as determined by a positive response to at least 2 of the 5 patient satisfaction questions.

To assess safety using NCI CTCAE v5

Eligibility criteria: Inclusion Criteria:

1. Outpatient at MD Anderson Cancer Center
2. Adult patients ≥ 18 years
3. Diagnosis of hematological malignancy
4. ESAS Sleep\&amp;gt;/=4
5. Performance status as measured by Eastern Cooperative Oncology Practice group (ECOG) score of 2 or below

Exclusion Criteria:

1. Platelet count of 25 or below
2. History of seizures/intracranial metastasis/ sleep apnea/restless leg syndrome/paralysis
3. Weight less than 150 lbs.
4. Attending physician assessment of prognosis with expected life expectancy of \&amp;lt;1 month
5. Patients who are unable to tolerate their blankets/sheets in the night due to medical conditions such as pain, peripheral neuropathy, night sweats, hot flashes etc.
6. Patients with difficulty breathing, disorders of poor circulation, fragile skin, rash, or open wounds, or by those who are claustrophobic or cleithrophobic.
7. Prior use of weighted blankets within the past 1-year

Primary outcomes:
measure: Safety and Adverse Events (AEs)
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Santhosshi Narayanan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: