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

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: NCT06903507
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-03
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-07
• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The percentage of patients that prefered the newly developed comfort mattress over the standard thin foam matt	Prior to radiotherapy planning-CT acquisition.	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.

Secondary Outcome Measures

Name	Time	Method
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 11-point NRS ranges from 0 (equivalent to no pain) to 10 (the worst pain imaginable).
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 positioning stability on the mattress was considered sufficient if two requirements were met; (1) the sagging (i.e.: the change in vertical position over time) during the first 5 minutes of dose delivery should be less than 1 mm averaged over all patients, (2) the variation in vertical position over time should not be larger compared to patients positioned during treatment on the standard matt.
The level preferrence of patients for the mattress of choice.	Prior to radiotherapy planning-CT acquisition.	The included patients tested the regular matt and the RT-Comfort Mattress by lying on each for one minute in radiotherapy position, on the flat and hard CT scanner couch. Next, they identified their mattress of choice, and the level of preference; slight or strong.
The dosimetrical effect of the RT-Comfort Mattress in the beam	The dosimetrical effect was evaluated immediately after the radiotherapy treatment.	As negligible dosimetric effect was expected, the original treatment plan was generated in the treatment planning system without taking the RT-Comfort mattress in account. To investigate the expected negligible effect of the mattress attenuation on 95% dose coverage of the planning target volume (PTV) and maximum skin dose, the treatment plans were recalculated and reoptimized while accounting for the RT-Comfort mattress using the same treatment planning system. The skin contour was defined as the outer 5-mm of the patient body contour for all CT-slices that included a PTV contour. The PTV itself was excluded from the skin structure.

Trial Locations

Locations (1)

Erasmus MC Cancer Institute; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands