Weighted Blankets for Blood Cancers

Overseen By Santhosshi Narayanan, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Seizures, Sleep apnea, Paralysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the impact of weighted blankets on sleep quality in individuals with blood cancers. Weighted blankets provide a calming effect through deep pressure stimulation. The study will include participants with sleep issues who have been diagnosed with a blood cancer and experience poor sleep quality. Participants must weigh at least 150 pounds and receive treatment at MD Anderson Cancer Center. As an unphased trial, this study offers a unique opportunity to explore non-drug interventions for improving sleep quality.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that weighted blankets are safe for patients with blood cancers?

Research has shown that weighted blankets are generally safe for people, including those with blood cancers. Studies have found that adults undergoing chemotherapy can use these blankets without issues. No major reports of negative effects have emerged from using weighted blankets in these situations. In fact, they can help reduce anxiety in both adults and children with cancer. Thus, weighted blankets offer a safe way to enhance sleep and comfort without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using weighted blankets for blood cancer patients because they offer a new, non-invasive way to improve sleep for those dealing with insomnia. Unlike traditional treatments that may involve medication, weighted blankets provide a simple and drug-free method, potentially reducing the side effects associated with pharmaceuticals. The gentle pressure from the blankets may help soothe anxiety and promote relaxation, offering comfort to patients who often experience sleep disturbances as part of their condition. This approach is particularly promising because it can be easily implemented alongside existing cancer treatments without additional risk.

What evidence suggests that weighted blankets are effective for improving sleep quality in patients with blood cancers?

Research has shown that weighted blankets can help reduce anxiety in cancer patients. Studies have found that these blankets make treatments like chemotherapy less stressful by providing a calming and comforting effect, similar to a firm hug. While most research has focused on anxiety, reducing anxiety often leads to better sleep. This trial will evaluate the effects of weighted blankets on patients with blood cancers, with separate arms for patients over 200 pounds and those between 150-200 pounds. Although more research is needed specifically for blood cancer patients, these blankets have shown promise in helping people relax and feel better. ^{3 4 6 7 8}

Who Is on the Research Team?

Santhosshi Narayanan

Principal Investigator

The University of Texas MD Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult patients (18+) with blood cancers who are outpatients at MD Anderson Cancer Center. They should be relatively active, with an ECOG score of 2 or lower, and have sleep issues rated 4 or higher on the ESAS scale.

Inclusion Criteria

I can walk and take care of myself despite my illness.

I am an outpatient at MD Anderson Cancer Center.

I often have trouble sleeping.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use weighted blankets to improve sleep quality over a 14-day period

2 weeks

Initial visit for blanket distribution, follow-up visit after 14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Weighted Blanket

Trial Overview The study is testing whether weighted blankets can improve sleep quality in patients with blood cancers. Participants will use a heavier blanket filled with weight beads to see if it helps them feel calmer and sleep better.

How Is the Trial Designed?

Group I: Patients more than 200 pounds Experimental Treatment 1 Intervention

Participants will be screened for insomnia using the ESAS tool.

Group II: Patients between 150-200 pounds Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Gabrielles Angel FDN for Cancer Research

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

Cognitive behavioural therapy integrated with activity pacing (CBT-AP) significantly reduced fatigue and depression in breast cancer patients undergoing chemotherapy, as shown in a randomized controlled trial with severely fatigued patients.

The CBT-AP intervention improved patients' quality of life, demonstrating its effectiveness over usual care, and it is recommended for integration into routine cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of cognitive behavioural therapy integrated with activity pacing on cancer-related fatigue, depression and quality of life among patients with breast cancer undergoing chemotherapy in Ethiopia: A randomised clinical trial. Getu, MA., Wang, P., Addissie, A., et al.[2023]

Massage therapy has shown potential benefits for cancer patients, particularly in reducing anxiety and pain, making it a supportive therapy in medical centers.

Further research with larger and more consistent patient groups is needed to determine the most effective types of massage for different cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of massage therapy in cancer care. Myers, CD., Walton, T., Small, BJ.[2011]

The bedside wellness system (BSW) significantly reduced fatigue and nausea (emesis) in cancer patients undergoing chemotherapy, with statistically significant improvements observed 3-5 days post-treatment.

This randomized clinical trial suggests that BSW is an effective new therapeutic method for enhancing mental well-being and alleviating side effects in palliative care, indicating its potential for broader application in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the bedside wellness system during chemotherapy decreases fatigue and emesis in cancer patients. Oyama, H., Kaneda, M., Katsumata, N., et al.[2019]

Massage therapy has been shown to provide significant benefits for cancer patients, including improved relaxation, sleep quality, immune responses, and relief from fatigue, pain, anxiety, and nausea.

Due to these positive effects, some major cancer centers in the U.S. are beginning to incorporate massage therapy into their treatment programs, highlighting its importance in addressing the emotional and physical needs of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of massage therapy in cancer care. Russell, NC., Sumler, SS., Beinhorn, CM., et al.[2011]

Citations

1. withpower.com withpower.com/trial/phase-neoplasms-11-2024-83b96

Weighted Blankets for Blood Cancers · Info for Participants The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers.

2. oncologynurseadvisor.com oncologynurseadvisor.com/news/weighted-blankets-reduce-anxiety-pediatric-oncology-patients-treatment/

Weighted Blankets Significantly Reduce Anxiety in ... Weighted blankets significantly reduced acute anxiety among pediatric oncology patients following chemotherapy infusion, according to a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05041075

Effect of Weighted Blankets on Anxiety for Pediatric ... 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.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40662270/

Effects of Weighted Blankets on Anxiety for Pediatric ... Weighted blankets are a potential intervention to address anxiety for pediatric oncology patients. The goal of this work is to assess the ...

5. dana-farber.org dana-farber.org/newsroom/news-releases/2024/dana-farber-cancer-institute-delivers-simple-immediate-impact-to-patient-comfort-using-weighted-blankets

Dana-Farber Cancer Institute delivers 'simple immediate ... The results of the project showed how patients' anxiety during infusion treatments eased when using weighted blankets of varying sizes – with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06089408

Weighted Blanket Use to Reduce Anxiety in Oncology ... This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. chemotherapy, targeted therapy etc.) ...

7. ons.org ons.org/system/files/journal-article-pdfs/VinsonAugustCJON2020.pdf

Weighted Blankets Based on the results of this study, weighted blankets are a safe therapy option for adult patients receiving chemotherapy in the outpatient ...

8. blogs.the-hospitalist.org blogs.the-hospitalist.org/content/weighted-blankets-may-help-reduce-preoperative-anxiety-during-mohs-micrographic-surgery

Weighted Blankets May Help Reduce Preoperative Anxiety ... Enhancing patient comfort and well-being during the procedure may help reduce negative emotional sequelae, alleviate fear during procedures, and increase ...