The Comfort Study: Determining the Most Comfortable Radiotherapy Mattress
Phase: NA
Conditions: Neoplasms
Sponsor: Erasmus Medical Center

The COMFORT study 
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TEMPLATE RESEARCH PROTOCOL 
for non-WMO-applicable research 
19-01-2023, versie 2

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Table of Contents 
 
List of abbreviations and relevant definitions .............................................................................. 5 
Summary ................................................................................................................................... 6 
 
Introduction and rationale ................................................................................................ 8 
 
Objective(s) ..................................................................................................................... 8 
 
Study type ....................................................................................................................... 8 
 
Study population .............................................................................................................10 
 
Methods .........................................................................................................................10 
 
Incidental findings ...........................................................................................................12 
 
Statistical analysis  .........................................................................................................12 
 
Ethical considerations .....................................................................................................13 
 
Handling and storage of data / images / sound recordings / photos / film recordings ......14 
 
Handling and storage of human material .....................................................................15 
 
Exchange, sharing or transfer of data and/or human material and/or images ..............16 
 
Amendments ...............................................................................................................17 
 
End of study report  .....................................................................................................17 
 
Publication ..................................................................................................................17 
 
References .................................................................................................................17 
 
Attachments ................................................................................................................17 
 
 
Please note that it is not allowed to remove paragraphs from this template protocol. If a paragraph is 
not applicable, please mention this in the specific paragraph, preferably with a short motivation.  

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List of abbreviations and relevant definitions* 
 
CTA 
Clinical Trial Agreement 
De novo biobank 
A new data, human material or imaging collection 
DMP 
Data Management Plan 
DPIA 
Data Protection Impact Assessment 
DTA 
Data Transfer Agreement 
Exception consent 
Form Care for data Template, in Dutch: Formulier uitzondering toestemming 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation in Dutch: Algemene Verordening 
Gegevensbescherming 
IC 
Informed Consent 
IFU 
Instruction For Use 
MTA 
Material Transfer Agreement 
NWTC 
Non-WMO Review Committee; in Dutch: Niet WMO Toetsingscommissie 
UAVG 
Dutch Act on Implementation of the General Data Protection Regulation; in 
Dutch: Uitvoeringswet Algemene Verordening Gegevensbescherming 
WMO 
Medical Research Involving Human Subjects Act, in Dutch: Wet Medisch-
wetenschappelijk Onderzoek met Mensen 
 
*Please add any new definitions that are used in the research protocol 
 
 
 
 
 
 
 

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Summary 
 
The summary should give a brief description of the central question that the research is intended to 
answer and its justification. It should specify the hypothesis (if applicable) and the research objectives. In 
addition, the synopsis should briefly describe the design, population, methods and procedures of the 
study. Finally, if applicable, the nature and extent of the burden and risks should be indicated.  
Rationale 
Please specify background and hypothesis (if applicable) of the study. 
The Erasmus MC radiotherapy department treats approximately 5500 patients per year. Roughly 2000 
patients are treated with palliative intent, which means that these are patients with metastasized cancer, 
who need to be irradiated to relieve complaints and/or improve their quality of life of their final stage of 
life. A large portion of the patients are treated for painful bone metastases at the dedicated outpatient 
clinic at the Erasmus MC radiotherapy department. 
The current radiotherapy workflow consists of a treatment preparation and a treatment delivery phase. At 
the dedicated outpatient clinic, patients are treated at the same day they had their intake or, if patients 
prefer, the day after. This means that the regular preparation phase of multiple days (up to a week) is 
reduced to less than a day (typically 3 to 6 hours in total). During the preparation phase a CT scan of a 
patient is acquired. This CT-scan is used to delineate the target volume and the organs at risk. Based on 
this information a patient specific treatment plan is generated. During the treatment delivery phase 
(approx. 15 minutes) it is very important that the patient is positioned according to the CT-scan. Therefore 
patients are positioned on an uncomfortable hard flat table top during both treatment phases. To 
somewhat improve the comfort for this patient group a thin mattress (not labeled as a medical device) is 
added during the normal clinical routine. 
To increase comfort and relieve the pain during the CT-scan and treatment delivery a thicker mattress 
was developed together with Royal Health Foam, and 6 samples were produced. These mattresses are 
no medical devices, since any effect they may have on the treatment is negligible. No special guidelines 
are available for these kind of mattresses. All mattresses were approved for standard clinical practice by 
the responsible medical physicist using the appropriate procedures at the department of radiotherapy. 
These procedures included radiation transmission measurements, ease of use and cleaning and phantom 
measurements to quantify the sag of the mattresses.  
Objective(s) 
Please specify the main and secondary objectives of the study. 
The primary objective is to determine if patients find the (newly developed) thicker radiotherapy mattress 
more comfortable than the standard thin matrass. 
The secondary objectives are: 
1. To determine if patients who experience pain while lying on any of the matrasses find the thicker 
radiotherapy matrass more comfortable than the standard thin matrass. 
2. To determine if the patient experience less pain while lying on the thick matrass compared to 
while lying on the thin matrass 
3. To record patient motion during treatment using the optical surface monitoring which is already 
used in routine clinical practice 
Study type 
Please describe the design of the study.  
A prospective observational study 
Study population 
Please describe the study population, e.g., healthy volunteers, xx year old. 

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Only patients (age ≥ 16) with bone metastasis in thoracic, abdominal and pelvis region who are treated at 
the one-stop shop for palliative radiotherapy are included in this study. The total number of patients that 
will be included is 45. See section 4.5 for more details. 
Methods 
Please describe how you conduct research and which methods are used. 
The study will be discussed with the patient by the treating physician during intake, or right after by a 
radiotherapy technologists (RTT). For patients that sign the informed consent, prior to planning-CT 
acquisition, patients will be asked to lie on each mattresses for 1 minute. Next patients are asked to score 
the pain they experienced, on a scale of 0-10 while lying on each mattress. Also patients are asked which 
mattress they prefer. Next the CT scan is acquired of the patients lying on the mattress of choice. The 
same mattress will also be used during irradiation. Note that both mattresses have been released for 
clinical use, and the choice of mattress does not affect the quality of the treatment. Only potentially the 
experienced comfort. 
Right before start of treatment and in line with clinical practice, patients will be positioned on the treatment 
couch with the aid of the optical surface monitoring system. The optical surface monitoring system makes 
a 3D scan of the surface of the patient from which it calculates the motion (3 translations, 3 rotations) of a 
predefined region of interest. During treatment, the quality of the treatment is evaluated based on the 
motion information, and if necessary, RTTs could pause the delivery. Specifically for the study, the motion 
of the patient will be assessed in more detail after treatment. 
 
Burden and risks 
Please describe the burden and risks associated with participation. 
There is no additional risk introduced by the treatment on thick mattress. 
The burden of the patient is limited to testing the mattress prior to CT-acquisition and scoring of its 
comfort. Which takes about 5 minutes. Both mattress are suitable for the radiotherapy treatment. So the 
choice of mattress does not affect the treatment. 
Recruitment and consent 
Please describe the recruitment and informed consent procedures. 
Patients will be asked to sign informed consent by the radiation oncologist during intake or by the RTT 
right after intake.  
 
 
 

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 Introduction and rationale 
Please specify background and hypothesis (if applicable) of the study. 
 
Together with Royal Health Foam, the department of Radiotherapy developed a new mattress, which 
could replace the thin mattresses that are currently in use for patient positioning during treatment. The 
only purpose for this mattress is to offer comfort to patients, that are treated on a flat treatment couch 
at the radiotherapy treatment machine. To improve the comfort of the mattress, the new mattress is 
thicker than the mattress currently in use. Especially for patients that are treated with palliative intent 
who are often frail and in pain, it is expected that the thick mattress could provide a more comfortable 
treatment experience.  
 
Because the thick mattress should not interfere with the dose delivered by the treatment machine, the 
thick mattress is made of dedicated materials. Although the thick mattress is not considered a medical 
device, all samples were evaluated for safe use in the clinic in terms of radiation transmission, and 
ease of use and cleaning. Also the positioning stability of a phantom and two volunteers on the 
mattress was assessed and within tolerances. After which the mattress has been approved for clinical 
use at the department of radiotherapy. 
 
 Objective(s) 
The objectives of the study are the questions that the study is intended to answer and are based on 
the scientific rationale and/or hypothesis formulated.  
Please specify the main and <if applicable> secondary objective(s) of the study. 
 
The primary objective is to determine if patients find the thicker radiotherapy mattress more comfortable 
than the standard thin matrass. 
The secondary objectives are 
1. 
To determine if patients who experience pain while lying on any of the matrasses find the 
thicker radiotherapy matrass more comfortable than the standard thin matrass. 
2. 
To determine if the patient experience less pain while lying on the thick matrass 
compared to while lying on the thin matrass  
3. 
To record patient motion during treatment using the optical surface monitoring device that 
is used in routine clinical practice for patient positioning. 
 Study type 
 
3.1. Study type  
 
☐ Retrospective 
☒ Prospective 
☐ Combination Retrospective/Prospective 
 
3.2.  Single center / Multicenter 
 
☒ Single center 
☐ Multicenter 
 

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3.3  Check all the applicable boxes 
 
☒ Medical records (re-use of data from healthcare, including AI) 
☐ Case report 
☐ Re-use data from research 
☐ Evaluations of quality of healthcare (retrospective) 
☐ Research with additional use of residual material from regular healthcare 
☐ Research with re-use of human material from research or existing biobank 
☐ De novo biobank 
☐ Phase IV research 
☒ Healthcare evaluation research (prospective) 
☐ Research with medical devices 
☐ Research with In Vitro Diagnostic Tests 
☐ Other research, describe 
 
 
 
 
 
 

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 Study population 
 
4.1. Study population 
 
☒ Adults (16 years and older) 
☐ Minors (younger than 16 years) 
☐ Incapacitated adults (16 years and older) 
☐ Incapacitated minors (younger than 16 years) 
 
4.2. Population (base)  
Describe the population (patients and controls if applicable), e.g. healthy human volunteers, xx-xx 
year old, adults, minors and/or incapacitated adults or minors. Specify and justify the number of 
subjects required for the study. 
Patients that are treated at the one-stop shop at Erasmus MC for palliative radiotherapy. For the 
required number of patients see section 4.5 
4.3. Inclusion criteria 
In order to be eligible to participate in this study, a subject must meet all of the following 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. 
 
4.4. Exclusion criteria 
A potential subject who meets any of the following criteria will be excluded from participation in 
this study:  
 
Patients not willing or able to test two mattresses (regular and thicker) 
 
4.5. Sample size calculation 
Specify and justify the number of subjects required for the study, estimated number of subjects, or 
number of subjects in the period of evaluation. 
 
The estimated number of patients needed for evaluation of mattress preference is 36. This 
number is calculated for a one-sample proportions z-test with an estimated preference for thick 
mattress of 70%, with ±15% error margin and a confidence level of 95%. These power 
calculations were performed by Yvette van Norden, statistician at Erasmus MC. 
For some patients the optical surface monitoring system may not be able to accurately detect the 
body of the patients, for instance due to too much body hair. These patients will be included for 
the primary objective, but cannot be evaluated for the third secondary objective. To account for 
these patients, accrual will continue until either 36 patients are included that can be evaluated for 
all objectives or a maximum number of total patients of 45. 
 
 Methods 
 
5.1. Research methods 
Please describe how you conduct research and which methods are used, e.g., questionnaires, 
human material collection, extraction of data from medical records, analysis of images, the use 
of an app/medical device/diagnostic test, clinical tests to be performed, etc. Include information 

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on frequency, duration, volumes. If a Data Management Plan is available, please upload DMP. 
 
Included patients are asked to test the regular and thick mattress for 1 minute each, right before 
CT scanning. Directly after testing each mattress, patients are asked to score whether they 
experienced pain lying on any of the mattress (score 0-10) and asked which mattress they 
prefer. Next the CT scan will be acquired with the mattress of choice. Note that the choice of 
mattress does not affect the quality of the treatment. 
 
In line with clinical routine, right before treatment, the positioning of the patient on the treatment 
couch is assessed using an optical surface scanning system. The system acquires a 3D scan of 
the surface of the patient to verify the patient position right before treatment. To evaluate the 
quality of the treatment, the patient potion during treatment is also monitored by the same 
system. Of the 3D surfaces scans that are acquired over time during treatment, only the 3D 
motion (3 translation and 3 rotations) will be assessed. In the figure below the 3D surface is 
indicated in white, with the predefined region of interest in yellow. The average motion is shown 
as the white curve within the green rectangle. All data is stored as radiotherapy treatment 
information in the context of the treatment. For the research, however, only the 3D motion will 
be assessed. Next the motion vector will be post-processed using a fast Fourier transform to 
filter out the breathing motion.  
 
 
5.2. Standard clinical care versus extra for research  
Indicate which of the methods are part of standard clinical care and which tests and/or visits are 
extra for research purposes i.e., not standard clinical care. 
 
The testing and scoring of both mattresses is extra for research purposes, i.e.: not standard 
clinical care. The monitoring of the patient positioning stability will be applied conform standard 
clinical care. 
 
5.3. Burden and risks 
Please describe the burden and risks associated with participation, e.g. the amount and number 
of blood samples, biopsies, liquor, hair, urine, nails, saliva etc., the number of site visits, physical 
examinations or other tests, questionnaires or diaries that have to be filled out, physical and 
psychological discomfort associated with participation. 
If there is no burden and risk because there is no direct involvement from participants needed 
please describe this. 
If a study is carried out with minors or incapacitated subjects, it should also be specified whether 
the risks are negligible and the burden minimal and why the study is group related (i.e., study 
can only be done using these patients groups). 
 
There is no additional risk introduced by the treatment on a thicker mattress. 

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The only additional burden of patients in the trial is the additional question asked to score the 
comfort of both mattresses prior to CT-acquisition, which is considered to be negligible. 
 
5.4. Medical device(s) / In vitro diagnostic tests 
Describe which medical device and/or in vitro diagnostic test is used, what the intended use of 
the medical device is and whether the medical device/diagnostic test is already available in the 
participating centers. 
 
Both mattresses are not considered to be a medical device. They are not part of the treatment 
machine, can be safely omitted and their impact on the dose delivery is negligible. 
 
Note here that this study is similar to the example about randomized studies at the CCMO 
website (https://english.ccmo.nl/investigators/legal-framework-for-medical-scientific-
research/your-research-is-it-subject-to-the-wmo-or-not).  This example describes a study on the 
prevention of decubitus, where subjects are randomized to the use of mattress A or B in their 
bed. Within the context of the WMO no rule of conduct is imposed in this example, and the use 
of another mattress is not considered as an infringement of the physical and/or psychological 
integrity of the subject. The website concludes that such randomized studies are not subject to 
the WMO, providing that no other procedures or rules of behavior are imposed (for instance 
taking blood samples). Note that he current study does not even randomize. 
 Incidental findings 
 
6.1. 
Chance of incidental findings 
Is there a chance of incidental findings? 
☐ Yes 
☒ No 
 
6.2. 
Procedures 
If yes, describe who will be notified and how the subjects and other parties will be notified in 
case of incidental findings from the study that may be in the interest for the participant’s health. 
 
Not applicable. 
 
 Statistical analysis 
Describe how data will be analyzed 
 
7.1 
Main study parameters/endpoints 
Please describe the main study parameters/endpoints. 
 
 
The percentage of patients that preferred the thick mattress 
 
7.2 
Secondary study parameters/endpoints 
Please describe the secondary parameters/endpoints, how the analysis will be done for the 
outcome parameters. 
 
1. 
Average comfort experienced by patients (score: 0-10) while lying on the thin and thicker 
mattress. 

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2. 
Average pain experienced by patients (score: 0-10) while lying on the thin and thicker 
mattress. 
3. 
Patient motion  
 
7.3 
Other study parameters 
Please describe the other parameters/endpoints. 
 
 
Treatment site 
 
Weight 
 
7.4 
Analysis 
Please describe how the analysis will be done for the outcome parameters. 
 
 
The mattress preference is calculated as the fraction of patients that preferred the thick 
mattress: number of patients who chose the thick mattress / the total number of patients 
included. Also the confidence intervals will be investigated. 
 
The experienced comfort per mattress is calculated as the average of the patients’ scores. 
Also the distribution of the scores per group (preference for thin vs thick mattress) and 
confidence intervals will be investigated 
 
The experienced pain per mattress is calculated as the average of the patients’ pain scores. 
Also the distribution of the scores per group (preference for thin vs thick mattress) and 
confidence intervals will be investigated 
 
The motion is defined by the translation (in 3D) measured by the AlignRT® camera system, 
after exclusion from the breathing motion based on a fast Fourier transform. 
  
 Ethical considerations 
 
8.1 
Regulation statement 
The study will be conducted according to the principles of the Declaration of Helsinki (version, 
date, see for the most recent version: www.wma.net), Gedragscode Gezondheidsonderzoek 
2022 and in accordance with other guidelines, regulations and Acts (if applicable, please 
specify). 
 
8.2 
Informed consent 
Will the subjects be asked for informed consent? 
☒ Yes (Upload Participant Information Letter and Informed Consent) 
☐ No, consent already given in previous study (Upload Participant Information Letter and 
Informed Consent previous study) 
☐ No, this research will be performed under the exception consent (Upload form Care for data 
Template, in Dutch: Formulier uitzondering toestemming) 
☐ Other (e.g. partly, indirectly) Please describe the situation. 
 
8.3 
Recruitment and informed consent procedures 
If yes, please give a description of the recruitment and informed consent procedures. How and 
by whom (investigator, supervising doctor, other person) participants will be informed about the 
study and asked for their consent, how much time will they be given to consider the decision. 
The patient information letter with informed consent form should be attached as a separate 

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document. 
 
The COMFORT study will be explained to eligible patients by the radiation oncologist during 
intake or by the RTT right after intake. After explanation, patients will be asked to sign informed 
consent. 
Please note that for patients treated at the One-Stop Shop for palliative radiotherapy, time 
between first consult and CT-scan acquisition is limited, and therefore the time to consider 
participation is relatively short (1 to 60 minutes). However, considering the limited burden for 
the patient and the simplicity of the research question, this short time should be sufficient. 
8.4 
Exception consent 
If no, exception consent: describe how it is safeguarded that subjects are excluded who have 
objected against the re-use of their data, human material, images. 
The Form Care for data Template should be attached as a separate document. 
 
Patients can always withdraw from the COMFORT study by requesting their radiation 
oncologist. 
 
 Handling and storage of data / images / sound recordings / photos / film recordings 
 
9.1 
Data / images / sound recordings / photos / film recordings 
Please describe which data / images / sound recordings / photos / film recordings is/are used, 
are they obtained for regular healthcare purposes or in the context a research project, or a 
combination. 
 
 
Age (healthcare purposes) 
 
Tumor site (healthcare purposes) 
 
Weight (healthcare + research purposes) 
 
Surface monitoring (3D motion signals only) (healthcare + research purposes) 
 
Pain scores (healthcare + research purposes) 
 
Comfort scores (research purposes)  
 
9.2 
Privacy protection 
Describe how subject’s privacy is protected. Describe how, when and by whom data is coded 
(unique code without initials or date of birth) and how the key table is safeguarded, mention the 
General Data Protection Regulation. 
 
Please note: The handling of personal data has to comply with the EU General Data Protection 
Regulation and the Dutch Act on Implementation of the General Data Protection Regulation (in 
Dutch: Algemene Verordening Gegevensbescherming en Uitvoeringswet Algemene Verordening 
Gegevensbescherming). 
 
At enrollment in the study, each patient will be assigned a unique study ID number. Only 
pseudo-anonymous data using this study ID number will be provided to investigators for 
analysis; a separate file with the identifying information will be kept at a separate location on a 
secured network directory of Erasmus MC with restricted access, i.e. only for persons directly 
involved in data collection and data validation, and to the Erasmus MC ethics committee or any 

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other person or agency required by law (e.g. for purposes of monitoring or research audits). All 
personal data will be processed in full compliance with the AVG and UAVG.  
9.3 
Handling and storage of data 
Describe how data is handled and stored (i.e., which data management system/data capture 
system), anonymous / pseudonymized / coded / identifiable, who has access to the coded 
source data, how long data will be kept, which steps are taken to ensure data security, what 
happens with the data after the research has been completed. 
 
 All data will be handled conform the Dutch Act on Implementation of the General Data 
Protection Regulation (in Dutch: Uitvoeringswet Algemene Verordening Gegevensbescherming 
(UAVG)) and the Erasmus MC privacy regulations. Data will be collected in Castor EDC with 
controlled access rights and an automated audit trail. Data generated during the surface 
monitoring will be stored in an access controlled research environment on the servers of the 
department of Radiotherapy. The data will not contain directly identifying data. Instead a unique 
study ID number will be used. All data will be stored for 10 years after ending the study. 
Collected data will be secured against unauthorized access and will be stored and secured by 
the department of Radiotherapy. Only pseudo-anonymous data will be provided to investigators 
for analysis. The separate file with the identifying information will be kept at a separate location 
on a secured network directory at Erasmus MC. 
 
9.4 
Handling and storage of images / sound recordings / photos / film recordings 
Describe how images / sound recordings / photos / film recordings are handled and stored, how 
the subject’s privacy is protected, anonymous / pseudonymized / coded / identifiable, what 
happens with images after the research has been completed. 
 
Data generated during the surface monitoring and imaging data (CT scans) will be 
pseudonymized by removing all identifying data and adding the unique study subject ID number. 
All details regarding pseudo-anonymization are described in the department protocol for image 
pseudo-anonymization which is also approved by the Erasmus MC PKO. The imaging data are 
stored on a secure server with controlled access for members of the project team only. Imaging 
data used for this research will be archived after the project has ended and kept for 10 years.  
 
 
9.5 
Approval of access to data / images / sound recordings / photos / film recordings 
Describe how the access is approved. Is access granted by the Data Board, Department, 
Principal investigator of the collection or other?  
 
The Department of Radiotherapy applies the same criteria for approval of requests to use imaging 
data for research as are applicable for use of data through the Health Data Platform. The Outcome 
Unit of the Dept. of Radiotherapy will perform a check on registration of the research project in 
PaNaMa and completion of the DPIA tasks, approval by the niet-wmo committee, availability of a 
data management plan, and a safe storage location for further processing of the data. After this 
check has been successfully completed the imaging data and surface monitoring data will be 
pseudonymized and transferred to the research environment. 
 
 
 Handling and storage of human material 
 
10.1 Human material 
Please describe which human material is used. 

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Not applicable 
 
10.2 Check all the boxes which are applicable to the human material origin: 
☐ Residual material from regular healthcare 
☐ Research (material acquired from a previous study).  
Add the reference of the study i.e., MEC-number Erasmus MC. 
☐ Re-use of human material from existing biobank 
      Describe whether the human material originates from research into the same disease.  
☐ Other, please specify 
 
10.3 Handling and storage of human material  
 
Not applicable 
 
☐ Anonymous, i.e. the material can never be traced back to an individual subject 
☐ Pseudonymized/Coded 
☐ Identifiable 
 
Describe how human material is handled and stored (i.e. which data management system / data 
capture system), anonymous / pseudonymized / coded / identifiable, who has access to the 
human material, how long the human material will be kept,  what happens with the data after the 
research has been completed. 
 
 Not applicable 
 
Biobank 
In case of new human material collection (biobank), describe how the human material is coded 
and stored (which registration system, Central Biobank or other location), who has access to the 
registration system and human material, by whom the key to the code is safeguarded, how  
long and where human material will be kept, what happens to the human material when the 
storage period is expired. 
 
Not applicable 
 
Approval of access to human material 
Describe how the access is approved. Is access granted by the Department, Principal 
investigator of the collection or other? 
 
Not applicable 
 
  Exchange, sharing or transfer of data and/or human material and/or images 
Describe with which organization the data and/or human material and/or images are shared, are they 
profit or non-profit organizations, whether these organizations are in the EU or outside the EU, how 
the privacy of subjects is protected outside the Erasmus MC and describe the procedures regarding 
the exchange(s), whether a Data Transfer Agreement/Material Transfer Agreement is available (if 

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yes, please upload the DTA/MTA). 
 
Collected data will not be exchanged, shared or transferred outside the Erasmus MC. 
 
 Amendments 
Amendments are changes made to the research after a favorable opinion by the NWTC has been 
given.  
 
All amendments must be submitted to the NWTC that gave the favorable opinion.  
Substantial amendments must be approved by the Niet WMO Toetsingscommissie before they can 
be implemented. 
 
 End of study report 
Within one year after the end of the study a final study report will be submitted with the results of the 
study, including any publications/abstracts of the study. 
 
In case the final study report will not be available within one year, another term should be defined 
including the reasons. 
 
 
 Publication 
Do you have the intention to submit the study results in a manuscript for publication in a journal: 
☒ Yes  
☐ No, please motivate 
 
Describe when the final study report with the results of the study will be submitted. 
 
The final report is expected to be submitted Q2 2024 
 References 
Include a list of all key references published in peer review journals that are relevant for the study 
and are discussed in the protocol 
To the best of our knowledge, no relevant literature exists with respect to mattress development for 
radiotherapy. 
 Attachments 
☒ Participant information letter and Informed consent document  
☐ Care for data Template – Formulier uitzondering toestemming  
☒ Questionnaires 
☐ Data Management Plan 
☐ Data Transfer Agreement 
☐ Material Transfer Agreement 
☐ Clinical Trial (Site) Agreement 
☐ Other, please describe