Increasing Patient Comfort in Palliative Radiotherapy With a Newly Developed Mattress - A Prospective Clinical Study

NCT06903507 | Completed

• 1 other identifier: MEC-2023-0295
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to determine if a new radiotherapy mattress is more comfortable for patients than the standard mattress. The table of the CT scanner and the radiation machine is flat and hard. To increase comfort during the CT scan and radiation dose delivery, the investigators have recently developed a new mattress (RTComfort). This research aims to find out if the new mattress is more comfortable for patients than the standard matt and to learn how radiotherapy mattresses can be further improved. Patients who participate in the research, will be asked to try both the standard mattress and the new mattress during the CT scan appointment. This will take about 5 minutes (one minute each). Patients will then be asked which mattress was most comfortable and if they experience any pain while lying on the mattress. Patients can choose which mattress will be used for the CT scan and treatment. Both mattresses are approved and safe for treatment. If patients participate in the research, it means the investigators will collect and use some of their (medical) data. Patients will not have any direct benefits from participating in this research, except that they can choose which mattress they want to lie on. Additionally, participation can help us gain more knowledge to make radiotherapy treatment more comfortable. Participation in the research will not affect the treatment. Participants will receive the normal treatment and check-ups for their condition. The drawback of participating is that the investigators will ask patients to try both mattresses, which will take about 5 minutes.

Conditions

Neoplasms

Keywords

radiotherapy; palliative radiotherapy; radiation oncology; comfort; pain; mattress; bone metastasis

Outcome Measures

Primary Outcomes (1)

• The percentage of patients that prefered the newly developed comfort mattress over the standard thin foam matt

  The included patients tested the RT-Comfort Mattress and standard thin foam matt by lying on each for one minute in radiotherapy position, on the flat and hard CT scanner couch. Next, after patients identified their mattress or matt of choice, the treatment preparation and delivery were performed on their mattress or matt of choice according to standard clinical practice.

  Prior to radiotherapy planning-CT acquisition.

Secondary Outcomes (4)

• The level preferrence of patients for the mattress of choice.

  Prior to radiotherapy planning-CT acquisition.

• The pain patients experienced while lying on the comfort mattress and the standard thin foam matt, according to the 11-point Numerical Rating Scale (NRS).

  Prior to radiotherapy planning-CT acquisition, while lying on each mattress for one minute in treatment position.

• The positioning stability of patients on the comfort mattress and the standard thin foam matt, measured with optical surface scanning

  During the first treatment fraction, the patients' surface scanning measurements were started directly after CBCT positioning verification and stopped directly after treatment dose delivery.

• The dosimetrical effect of the RT-Comfort Mattress in the beam

  The dosimetrical effect was evaluated immediately after the radiotherapy treatment.

Study Arms (2)

RT-Comfort Mattress

EXPERIMENTAL

In this arm, the RT-Comfort Mattress was applied on top of the flat and hard radiotherapy treatment couch during planning CT acquisition and treatment dose delivery.

Device: RT-Comfort Mattress

Standard thin foam matt

NO INTERVENTION

For patients with painful bone metastasis, a standard thin foam matt is typically added on top of the flat and hard radiotherapy treatment couch to somewhat relief the pain. Unfortunately, this existing matt is too thin to effectively counter discomfort and pain.

Interventions

RT-Comfort Mattress DEVICE

This dedicated RT-Comfort Mattress was newly developed (patent pending) for increasing comfort without compromising radiotherapy treatment quality.

RT-Comfort Mattress

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 16
• Patients treated for bone metastasis in thoracic, abdominal and pelvic region
• Patients have read, understood and signed the informed consent of the COMFORT study (in Dutch).

You may not qualify if:

• Patients not willing or able to test two mattresses (RT-Comfort Mattress and standard thin foam matt)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Royal Health Foam: collaborator

Study Sites (1)

Erasmus MC Cancer Institute

Rotterdam, South Holland, Postbus 2040 / 3000 CA, Netherlands

Location

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Remi Nout, Proffessor

  Erasmus MC Cancer Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 30, 2025
• Study Start: August 3, 2023
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)