Clinical trial NCT06903507: Increasing Patient Comfort in Palliative Radiotherapy With a Newly Developed Mattress - A Prospective Clinical Study
Official title: The Comfort Study: Determining the Most Comfortable Radiotherapy Mattress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Keywords: radiotherapy
palliative radiotherapy
radiation oncology
comfort
pain
mattress
bone metastasis
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Royal Health Foam
First posted: 2025-03-30
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: The percentage of patients that prefered the newly developed comfort mattress over the standard thin foam matt
timeFrame: Prior to radiotherapy planning-CT acquisition.
Secondary outcomes:
measure: The level preferrence of patients for the mattress of choice.
timeFrame: Prior to radiotherapy planning-CT acquisition.
measure: 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).
timeFrame: Prior to radiotherapy planning-CT acquisition, while lying on each mattress for one minute in treatment position.
measure: The positioning stability of patients on the comfort mattress and the standard thin foam matt, measured with optical surface scanning
timeFrame: During the first treatment fraction, the patients' surface scanning measurements were started directly after CBCT positioning verification and stopped directly after treatment dose delivery.
measure: The dosimetrical effect of the RT-Comfort Mattress in the beam
timeFrame: The dosimetrical effect was evaluated immediately after the radiotherapy treatment.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC Cancer Institute
state: Zuid-Holland
Study officials:
affiliation: Erasmus MC Cancer Institute
name: Remi Nout, Proffessor
role: STUDY_DIRECTOR
References: