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

NCT ID: NCT06903507

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2023-12-07

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT-Comfort Mattress

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.

Group Type: EXPERIMENTAL

RT-Comfort Mattress

Intervention Type: DEVICE

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

Standard thin foam matt

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RT-Comfort Mattress

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Health Foam

UNKNOWN

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Steven Petit

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Remi Nout, Proffessor

Role: STUDY_DIRECTOR

Erasmus MC Cancer Institute

Locations

Erasmus MC Cancer Institute

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MEC-2023-0295

Identifier Type: -

Identifier Source: org_study_id