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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Weighted Blanket for blood cancers?

While there is no direct evidence for weighted blankets in blood cancer treatment, research on similar therapies like massage shows they can help reduce stress, anxiety, and fatigue in cancer patients. These benefits might suggest that weighted blankets could also provide comfort and relaxation. ^{1 2 3 4 5}

How is the weighted blanket treatment different from other treatments for blood cancers?

The weighted blanket treatment is unique because it focuses on reducing stress and improving mental well-being, which can help alleviate side effects and mental distress during cancer treatment, unlike traditional treatments that primarily target the cancer itself. ^{1 6 7 8 9}

Research Team

Santhosshi Narayanan

Principal Investigator

The University of Texas MD Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 0 Interventions

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using the bedside wellness system during chemotherapy decreases fatigue and emesis in cancer patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Role of massage therapy in cancer care. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

The value of massage therapy in cancer care. [2011]

4. England pubmed.ncbi.nlm.nih.gov

The effect of slow-stroke back massage on chemotherapy-related fatigue in women with breast cancer: An assessor blinded, parallel group, randomized control trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A hospital-based intervention using massage to reduce distress among oncology patients. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Factors associated with sleep quality during chemotherapy: An integrative review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Sleep disturbance of adults with a brain tumor and their family caregivers: a systematic review. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Factors associated with sleep health in young women after breast cancer treatment. [2022]

9. United States 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. [2023]