Using a weighted blanket to help cancer patients during IV therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled study enrolls adults with solid tumors receiving first-line IV anticancer therapy. Participants are stratified by gender and randomized to receive either a weighted blanket or a regular blanket during two chemotherapy or immunotherapy cycles. The approach uses patient-reported scales to track anxiety, distress, and comfort, and a survey assesses feasibility for nurses. The aim is to see if the weighted blanket can improve psychological well-being and overall comfort during treatment without compromising safety. The setting is the Sultan Qaboos Comprehensive Cancer Center in Muscat, Oman.

Why it matters

Who can join: the full rules

Inclusion Criteria: for patients

* Newly diagnosed cancer patients aged 18 years and older.
* Receiving first-line intravenous anticancer therapy (chemotherapy or immunotherapy or a combination of both) in the daycare unit (adjuvant, neoadjuvant, or palliative).
* Weighting at least 55 kg during obtaining the informed consent. (At least 54 kg before the intervention).
* Able to complete study assessments.
* Speaks Arabic or English.
* Signs Informed consent.

Exclusion Criteria for patients:

* Prior psychological treatment or psychotherapy (confirmed psychological diagnosis, history of psychotropic medications and previous psychotherapy).
* Currently hospitalized in inpatient units.
* Patients on daily anticancer infusions.
* Positive fall risk assessment.
* Open wounds and recent surgeries/ stoma.
* Enrolled in any other device study or clinical trial during data collection.
* History of:

  * Diabetes mellitus
  * Respiratory disorders,
  * Claustrophobia (Miller et al 2003) Because of the possibility for altered sensory perception,
  * Patients who had a diagnosis of peripheral neuropathy or fibromyalgia (Vinson et al. 2020)
  * Cognitive impairment

Eligibility criteria for the nurse's population:

Day Care Unit nurses will be recruited by convenient sampling and feedback will be sought per patient per visit. The reason to this is because the same nurses maybe caring for multiple patients using the WBs and each patient will provide a different experience for the nurses caring for those patients. Only nurses who agree to complete the study questionnaire will be included.

Where it's running

• Sultan Qaboos Comprehensive Cancer Care and Research Center - University Medical City
  Muscat, Seeb, Oman Recruiting

Study contacts

• Study coordinator: Aida M Al Kindy, BScN, MQM
• Email: a.alkindy@cccrc.gov.om
• Phone: +968-97655101

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.