Hematological Malignancies
Conditions
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
Interventions
OTHERWeighted Blanket
Participants will be given a weighted blanket
Sponsors
M.D. Anderson Cancer Center
Gabrielles Angel FDN for Cancer Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSanthosshi Narayanan, MBBS
M.D. Anderson Cancer Center
Outcome results
None listed