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Trial Title:
Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients with Hematological Malignancies
NCT ID:
NCT06584955
Condition:
Hematological Malignancies
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Outpatient at MD Anderson Cancer Center
2. Adult patients ≥ 18 years
3. Diagnosis of hematological malignancy
4. ESAS Sleep>/=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
<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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 31, 2024
Completion date:
July 31, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06584955
http://www.mdanderson.org
