Personalised and Gamification-based Decision Aid (DA): a Randomized Controlled Pilot Study About Colorectal Cancer (CRC) Screening
Phase: NA
Conditions: Colo-rectal Cancer
Sponsor: University of Pavia

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Study Title 
Personalised and gamification-based Decision Aid (DA): a randomized controlled pilot study about 
colorectal cancer (CRC) screening. 
NCT Number 
NCT ID not yet assigned 
Protocol Date 
March 28, 2024 
 
 

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STUDY PROTOCOL 
 
Study Title 
Personalised and gamification-based Decision Aid (DA): a randomized controlled pilot study about 
colorectal cancer (CRC) screening. 
Acronym: DA-CRC 
Protocol Version and Date: Version 2 — March 28, 2024 
1. Rationale 
Colorectal cancer (CRC) accounts for approximately 10% of all cancers diagnosed worldwide¹. 
Numerous studies have shown that CRC screening using the faecal occult blood test (FOBT) can 
reduce mortality; however, the procedure is also associated with certain drawbacks, including false 
negatives and false positives, overdiagnosis, overtreatment, and potential complications from 
colonoscopy¹. Therefore, the decision to undergo or not undergo screening should be an informed 
one². 
To support this process, Decision Aids (DAs) have proven useful³˒⁴. These are decision-support tools 
designed to help individuals make informed choices about their health. 
The scientific literature⁴–⁶ reports several studies related to cancer screening tests, which in some 
cases have been associated with increased adherence to screening programs⁵. In Italy, where three 
national screening programs are currently active (CRC, breast cancer, and cervical cancer), only a 
recent development of a DA specifically for mammography screening has been documented⁶. 
To ensure that the decision to undergo FOBT screening is well informed, the use of a smartphone 
application has been proposed as a supportive tool. Such an application can also serve as a platform 
to assess the effectiveness of new communication strategies—such as tailoring language to 
educational level and adapting content feedback based on Locus of Control (i.e., the extent to which 
individuals believe that life events are determined by their own actions or by external factors beyond 
their control⁷)—as well as elements of Gamification⁸, a relatively new approach that applies game 
mechanics to non-game contexts to enhance user engagement. This technique introduces an element 
of enjoyment into routine activities, which can increase motivation and knowledge—in this case, 
serving as a tool to promote primary prevention and healthy lifestyle behaviours. 
The use of eHealth, particularly smartphone-based applications, has been increasingly documented 
in the literature as effective across various clinical fields⁹–¹². 
2. General Objective of the Study 
The general objective of this study is to evaluate the impact of a mobile application on informed 
decision-making regarding participation in colorectal cancer screening among individuals who will 
receive their first invitation to undergo the faecal occult blood test (FOBT), residing in the area 
covered by Brescia LHA. 
Secondary objectives include assessing the impact of using the application on screening adherence 
rates, evaluating decision conflict, customer satisfaction, and the acceptability of a smartphone 

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application, as well as examining its effectiveness in conveying information about primary prevention 
and healthy lifestyle behaviours. 
2.1. Primary Objective 
To evaluate the impact of using a smartphone application on users’ awareness and understanding 
regarding colorectal cancer prevention. 
2.2. Secondary Objectives 
1. To assess and compare screening adherence rates between the two study arms. 
2. To assess and compare, between the two study arms, the level of knowledge related to healthy 
behaviours and primary prevention. 
3. In the intervention arm, to evaluate decision conflict, customer satisfaction, and the acceptability 
of the mobile application. 
3. Endpoint 
3.1. Primary Endpoint  
The primary endpoint is users’ awareness in the field of cancer prevention, specifically regarding 
colorectal cancer screening. This will be assessed as a dichotomous variable by combining measures 
of knowledge, attitudes, and intentions, according to the three-dimensional framework by Marteau et 
al.¹³˒¹⁴ and comparing results between the two study arms. A participant will be considered to have 
made an informed choice if they have adequate knowledge and if their attitudes and behaviors are 
consistent. Among these three dimensions, adequate knowledge and consistent attitudes must be 
satisfied for the choice to be classified as “informed”. 
3.2. Secondary Endpoint 
1. Screening adherence rate, calculated as the ratio between the number of individuals who 
completed the screening and the total number of individuals invited to participate in the 
screening program in the two study arms. 
2. Level of knowledge related to healthy behaviors and primary prevention in the two study arms 
will be measured using a digital questionnaire containing 13 questions on primary prevention 
and healthy lifestyle behaviors. 
3. Decision conflict, customer satisfaction, and the acceptability of the application will be assessed 
through additional questions included in the same digital questionnaire. 
4. Study Plan and Design 
Studio clinico randomizzato controllato monocentrico. I partecipanti allo studio verranno assegnati 
al braccio di controllo oppure di intervento mediante randomizzazione semplice, che prevede 
l’utilizzo di una sequenza di numeri casuali preparata dallo statistico, generati con il supporto del 
computer. 
5. Inclusion and Exclusion Criteria  
Participants will be included in the study if they meet the following criteria: 
• 
Male and female citizens born between January 1, 1973, and December 31, 1974, who turned 
50 years of age in 2023 or will turn 50 in 2024, thereby becoming eligible for the national 
colorectal cancer screening program. 
• 
Residents in the area covered by Brescia LHA. 

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• 
Individuals who have provided informed consent to participate in the study. 
Participants without a smartphone will be excluded from the study 
6. Intervention  
Smartphone application not classified as a Medical Device. 
6.1. Intervention Procedures 
All subjects who meet the inclusion criteria will receive, through an attachment to the invitation letter 
(Annex 1) for screening, the instructions on how to download the application on their smartphone. 
Once downloaded, the application will allow exclusively to complete the informed consent (Annex 
2), to read the privacy policy (Annex 3) and subsequently the baseline questionnaire (T0) (Annex 4), 
in digital format. Afterwards, the users will be progressively randomized into an intervention arm and 
a control arm. Recruitment will be stopped upon enrollment of subject number 2500. 
Subjects assigned to the control arm will have access to the mobile application in a limited version. 
In a specific section, there will be standardized and digitalized scientific dissemination documents 
aimed at providing information on primary prevention, healthy and correct lifestyles, and on 
colorectal cancer screening. 
Subjects assigned to the intervention arm will have access to the full version of the application. In 
particular, in addition to the specific section available for the control group, users will be presented 
with the aforementioned information in the form of daily “pills.” Moreover, by completing one quiz 
per week and one twice a week, the user will be able to earn points based on the number of correct 
answers provided. The quizzes will be of two types: the first, weekly, will consist of 10 questions, 5 
regarding primary prevention topics and 5 on general knowledge; the second, every 3 days, will 
consist of 3 prevention-related questions. Users will have 15 seconds to answer each question, and 
the score, in case of a correct answer, will be assigned based on the time taken to select it. 
For both arms, it will be possible to fill in a follow-up questionnaire at T1 and T2 (Annex 5), 
respectively at 3 and 6 months from enrollment.  
The project foresees a total duration of 30 months. 
It is possible to identify three main phases: 
Phase 1, called Project Start-Up, consists of: 
1.1 Drafting of the Study Protocol 
1.2 Design of the CRF, creation of the electronic database and related completion manual 
1.3 Definition of the Statistical Analysis Plan (SAP) 
1.4 Preparation and submission of the documentation to the relevant Ethics Committee 
Phase 2, called Study Set-Up, includes: 
2.1 Identification of the cohort, patient enrollment and randomization 
2.2 Data quality control and query resolution (completeness, accuracy and consistency analysis) 
2.3 Progress meetings and related minutes 
Phase 3, called Statistical Analysis, consists of: 

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3.1 Data analysis and dissemination of results (publications and conference materials) 
6.2. Data Collection Tool 
Two digital questionnaires (to be completed directly within the App) will be used: one at time T0 
(baseline) and the second at time T1 (three months) and T2 (six months). In particolar: 
1. Within the questionnaire administered at baseline, the validated Multidimensional Health 
Locus of Control (MHLC) questionnaire¹⁵ is included. It contains eighteen questions through 
which the Locus of Control of the participants will be assessed. 
2. Informed choice will be evaluated through three items: knowledge (score of at least 7 out of 
13), attitude (score > 24), and intention (actual behaviour). Among these, the first two items 
must necessarily be satisfied⁵–⁸ in order to define that the subject is informed about the choice. 
3. The level of knowledge related to healthy behaviours and primary prevention will be assessed 
through the 13 questions on primary prevention and healthy lifestyle behaviours. Based on 
the number of correct answers, subjects will be classified into three categories: low knowledge 
(0 to 5 out of 13), good knowledge (6 to 8 out of 13), and excellent knowledge (9 to 13 out of 
13). 
4. Decision conflict, customer satisfaction, and the acceptability of the App will be assessed at 
T1 and T2 through specific items of the second questionnaire (decision-making process, 
satisfaction, and decision-aid acceptability). 
In addition, Brescia LHA will provide data on residents born in 1973 and 1974, by sex, and the 
number of subjects, by sex, who actually completed the FOBT screening. 
7. Study Duration and Planned Assessments 
The duration of the study will be 30 months. The enrollment period will take place from January 2023 
to August 2024, in conjunction with the invitation sent by Brescia LHA to citizens born in 1973 and 
1974 to undergo FOBT screening. Following the completion of the informed consent and the baseline 
questionnaire, users will be progressively randomized. 
The total enrolment period will last 20 months. Assessments for each subject will be performed at 
baseline (T0), at 3 months (T1), and at 6 months (T2). 
T0: questionnaire collecting information on socio-demographic data, risk perception, knowledge, 
attitude, intention, and Locus of Control. 
 
T1: questionnaire collecting information on risk perception, knowledge, attitude, intention, decision-
making process, customer satisfaction, and application acceptability. 
 
T2: same questionnaire administered at T1. 
8. Statistical Aspects  
8.1. Sample size 
Based on previous studies⁴˒¹⁶, we considered an absolute difference of 10% between the proportion 
of individuals who make an informed choice and those who do not to be the minimum important 
difference for the sample size calculation. Assuming that the proportion of individuals making an 
informed choice is 50%, with a power of 90% and a two-sided significance level of 5%, 519 subjects 
per group are required, for a total of 1,038 subjects. 

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Considering an estimated colorectal cancer screening adherence rate of 50% in the province of 
Brescia and a probable drop-out rate of 20%, at least 2,492 subjects will need to participate in the 
study. 
8.2. Statistical Methods 
Descriptive statistics will be used to describe the collected variables: mean and standard deviation, 
median and interquartile range for quantitative variables, and absolute frequencies and percentages 
for qualitative variables. The comparison between the proportion of subjects making an informed 
choice in the two groups will be evaluated using the Chi-square test, as will the comparison between 
the proportion of subjects adhering to screening in the two arms. 
Median scores obtained from the knowledge questionnaire will be evaluated using the Friedman test 
at the three time points. 
9. CRF and Data Management 
The subject data — collected through the electronic Case Report Form (CRF) (Annex 6) — will be 
kept confidential and used in accordance with the applicable legislation on the protection of sensitive 
data and privacy regulations. 
The ownership of the results generated by the study belongs to University of Pavia. 
10. Personal Data Processing 
Within the scope of personal data processing instrumental to the activities foreseen for the 
implementation of the predefined program PP02 “Active Communities” and the free program PL14 
“Oncological Screening” of the Piano Regionale Prevenzione 2021-2025, dated February 12, 2020, 
Brescia LHA and University of Pavia, Department of Public Health, Experimental and Forensic 
Medicine (hereinafter jointly referred to as the “Parties”), will act as independent data controllers 
with respect to the data subjects, in compliance with the principles of lawfulness, necessity, fairness, 
relevance and proportionality. Data will be processed exclusively for research purposes and limited 
to processing activities strictly related to such purposes, in accordance with the applicable legislation 
on personal data protection. 
For all personal data processing activities, the Parties shall adopt all necessary technical and 
organizational measures to ensure that the rights of the data subjects, pursuant to Regalement (UE) 
2016/679 (GDPR), can be guaranteed at any time and within the time limits set by law. The Parties 
undertake to make available to each other, where necessary, any information useful to demonstrate 
and verify compliance with their respective obligations under the current data protection legislation, 
and to cooperate in the event of requests from the Supervisory Authority or the Judicial Authority 
concerning the processing of data related to the activities governed by the existing agreements. 
The Parties undertake to restrict the circulation and processing of personal data collected for the 
execution of the research project (e.g., storage, archiving and preservation of data on their own servers 
or in the cloud) to countries belonging to the European Union, with an explicit prohibition on 
transferring data to non-EU countries that do not ensure (or in the absence of) an adequate level of 
protection. In the absence of safeguards required by Regulation (EU) 2016/679 (third country deemed 
adequate by the European Commission, BCR, standard contractual clauses, etc.), the Parties also 
commit to carrying out a Data Transfer Impact Assessment (DTIA) prior to transferring any personal 
data processed under this Agreement to non-EU countries. 

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In particular: 
1. Brescia LHA will be responsible for promoting the research among subjects who may be 
eligible for recruitment. Brescia LHA will send invitation letters to the cohort of users born in 
1973 and 1974, who will receive their first invitation to undergo the faecal occult blood test 
screening, residing in the Brescia LHA area. In the letter, citizens will be invited to download a 
smartphone application, through which they will provide their consent to the use of their data by 
the University of Pavia. 
Brescia LHA will provide the University of Pavia with informational material containing 
notions on primary prevention and healthy lifestyles, as well as data on the number of residents 
born in 1973 and 1974 by sex and the number of individuals, by sex, who will have completed 
the screening by the end of the year. 
 
2. The Department of Public Health, Experimental and Forensic Medicine of the University of 
Pavia will be responsible for: 
• Defining the research project operationally; 
• Collecting data and consent from participants; 
• Developing a communication and information tool aimed at the population in order to 
achieve the objectives of the regional programs PP02 and PL14. 
The evaluation of the research results will be returned to Brescia LHA in anonymous form. 
The data flow diagram is shown below. 
 
11. Informed Consent 
The informed consent will be administered through the App upon first access. A copy of the consent 
will be stored in a dedicated file. 
12. Costs 
The study will be funded by Brescia LHA with a total amount of €30,000.00, VAT included. 
13. Data Ownership and Publications 

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The Department of Public Health, Experimental and Forensic Medicine of University of Pavia is 
responsible for collecting consent for the processing of personal data for research purposes related to 
individuals registered in the healthcare registry and will collaborate with Brescia LHA to identify 
subjects eligible for the study. The data will be kept strictly confidential and processed in accordance 
with Legge 196/2003 (so-called Privacy Law), using manual and/or electronic tools to ensure their 
security and confidentiality. A data protection officer will be appointed as the privacy contact person 
for the management of these data. 
The results of the study may be presented to the scientific community in the form of publications in 
national and international peer-reviewed journals and conference presentations, as well as for 
dissemination purposes (e.g., articles in newspapers or on websites), after prior sharing with Brescia 
LHA. The final version of such publications and dissemination material will be communicated (from 
the University to Brescia LHA) for a 15-day comment period. 
14. References 
1. Sung, H. et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and 
Mortality Worldwide for 36 Cancers in 185 Countries. CA. Cancer J. Clin. 71, 209–249 
(2021). 
2. Elwyn, G., Frosch, D. & Rollnick, S. Dual equipoise shared decision making: definitions for 
decision and behaviour support interventions. Implement. Sci. 4, 75 (2009). 
3. O’Connor, A. M. Risk communication in practice: the contribution of decision aids. BMJ 327, 
736–740 (2003). 
4. Stacey, D. et al. Decision aids for people facing health treatment or screening decisions. 
Cochrane Database Syst. Rev. 2017, (2017). 
5. Gabel, P., Larsen, M. B., Edwards, A., Kirkegaard, P. & Andersen, B. Effectiveness of a 
decision aid for colorectal cancer screening on components of informed choice according to 
educational attainment: A randomised controlled trial. PLOS ONE 15, e0241703 (2020). 
6. Roberto, A. et al. A dynamic web-based decision aid to improve informed choice in organised 
breast cancer screening. A pragmatic randomised trial in Italy. Br. J. Cancer 123, 714–721 
(2020). 
7. Rotter J.B. Social learning and clinical psychology. New York, Prentice-Hall (1954). 
8. Hammedi, W., Leclerq, T. & Van Riel, A. C. R. The use of gamification mechanics to increase 
employee and user engagement in participative healthcare services: A study of two cases. J. 
Serv. Manag. 28, 640–661 (2017). 
9. Mohamad Marzuki, M. F., Yaacob, N. A., bin Yaacob, N. M., Abu Hassan, M. R. & Ahmad, 
S. B. Usable Mobile App for Community Education on Colorectal Cancer: Development 
Process and Usability Study. JMIR Hum. Factors 6, e12103 (2019). 
10. Sequi-Dominguez, I. et al. Effectiveness of Mobile Health Interventions Promoting Physical 
Activity and Lifestyle Interventions to Reduce Cardiovascular Risk Among Individuals With 
Metabolic Syndrome: Systematic Review and Meta-Analysis. J. Med. Internet Res. 22, 
e17790 (2020). 
11. Duan, Y. et al. Effects of eHealth-Based Multiple Health Behavior Change Interventions on 
Physical Activity, Healthy Diet, and Weight in People With Noncommunicable Diseases: 
Systematic Review and Meta-analysis. J. Med. Internet Res. 23, e23786 (2021). 
12. Islam, M. M., Poly, T. N., Walther, B. A. & (Jack) Li, Y.-C. Use of Mobile Phone App 
Interventions to Promote Weight Loss: Meta-Analysis. JMIR MHealth UHealth 8, e17039 

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(2020).  
13. Michie, S., Dormandy, E. & Marteau, T. M. The multi-dimensional measure of informed 
choice: a validation study. Patient Educ. Couns. 48, 87–91 (2002). 
14. Marteau, T. M., Dormandy, E. & Michie, S. A measure of informed choice: A measure of 
informed choice. Health Expect. 4, 99–108 (2001). 
15. Wallston, K.A., Wallston, B.S., DeVellis, R. Development of the multidimensional health 
locus of control (MHLC) scales. Health Education Monographs, 6(2), 160-170 (1978). 
16. Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, et al. Use of a decision aid 
including information on overdetection to support informed choice about breast cancer 
screening: a randomised controlled trial. Lancet. 385:1642–52 (2015). 
15. Annexes 
1. Information Sheet and Informed Consent Form for Participation 
2. Information Notice on Personal Data Processing 
3. Letter to General Practitioners 
4. Approval Record of Study NP 5686 DA-CRC 

Study Title 
Personalised and gamification-based Decision Aid (DA): a randomized controlled pilot study about 
colorectal cancer (CRC) screening. 
NCT Number 
NCT ID not yet assigned 
Protocol Date 
March 28, 2024 
 
 

INFORMATION SHEET AND DECLARATION OF CONSENT TO PARTICIPATE 
 
Dear Sir / Madam, 
 
University of Pavia and Brescia Local Health Authority (LHA) are conducting a study entitled: “Personalised 
and gamification-based Decision Aid (DA): a randomized controlled pilot study about colorectal cancer (CRC) 
screening”. The aim of this study is to evaluate the impact of a smartphone application on users’ awareness 
regarding colorectal cancer prevention. 
This document explains why we believe you may be eligible to participate in this study. 
You have been selected because, having been born in 1973 or 1974, you have either received in 2023, or will 
receive in 2024, your first invitation to participate in the colorectal cancer screening program (this screening 
campaign is targeted at people aged 50 – 69 years) and you reside in the area covered by the Brescia LHA. 
This research, conducted exclusively among residents in the area covered by the Brescia LHA, requires the 
collaboration and availability of individuals like you who meet the above eligibility criteria. 
 
Before deciding whether to accept or decline participation, please read this document carefully, take all the 
time you need, and do not hesitate to ask for clarification if anything is unclear. You may contact the 
dedicated email address provided. If you wish, you can also consult your trusted physician before deciding. 
 
STUDY OBJECTIVES 
The primary objective of this research is to evaluate the impact of a mobile application on informed decision-
making regarding colorectal cancer screening. After you provide your consent to take part in the study, you 
will be randomly placed in either the control group or the intervention group. 
• 
If you are assigned to the control group, within the smartphone application, in a dedicated section, 
you will have access to digitized scientific educational documents providing you with information on 
primary prevention, healthy lifestyle habits, and colorectal cancer screening. 
• 
If you are assigned to the intervention group, the smartphone application will provide you with the 
same documents as the control group. In addition, the information will also be presented through 
short daily “information pills”. You will also could take part in quizzes on primary prevention and 
general knowledge topics. Based on the number of correct answers, your chosen nickname (selected 
during app registration) will appear on a leaderboard. 
Secondary objectives include: 
1. Evaluating and comparing adherence rates to the screening program between the two study groups. 
2. Evaluating and comparing the level of knowledge related to healthy behaviors and primary prevention in 
both groups. 
3. Assessing the decision-making process, satisfaction, and acceptability related to the application. 
 
BASELINE AND FOLLOW-UP ASSESSMENTS 
Regardless of the group you are assigned to, immediately after providing your consent and being enrolled in 
the study, you will be asked to complete a questionnaire. This will collect socio-demographic data, risk 
perception, knowledge, attitudes, intention to participate in the colorectal cancer screening program, and 
Locus of Control. 
 

At 3 months and 6 months after enrollment, you will be asked to complete a follow-up questionnaire 
collecting the same information (except for socio-demographic data) plus additional questions regarding the 
decision-making process and satisfaction with the use of the application. 
 
POTENTIAL RISKS 
No specific risks are expected as a result of participation in this study. 
 
VOLUNTARY PARTICIPATION AND WITHDRAWAL 
Your participation in this study is entirely voluntary. You may withdraw from the study at any time, without 
any consequences and without affecting your right to participate in the colorectal cancer screening program. 
 
OTHER IMPORTANT INFORMATION 
The study will be conducted in accordance with internationally recognized Good Clinical Practice (GCP) 
guidelines and in compliance with the ethical principles set out in the Declaration of Helsinki and the Oviedo 
Convention. 
 
Your participation in the study is entirely voluntary. Should you decide to participate, you will be asked to 
provide your informed consent as set out at the end of this document, before any procedures or assessments 
required by the study are carried out. By signing the consent form, you acknowledge that you have received 
full information and have freely agreed to participate in the study. 
The data collected during the study through the application will be shared with Brescia LHA. 
 
How is the confidentiality of information ensured? Who should I contact for further information? 
The data controller is the University of Pavia. For any further information, you may contact the dedicated 
email address. 
 
 
 

INFORMED CONSENT FORM 
 
I, the undersigned ……………………………………………………………………………..…, declare that I have carefully read 
and fully understood the information provided in this document. I hereby: 
 
□ Consent 
□ Do not consent 
 
to participate voluntarily in the study, having understood the nature of the request and the potential benefits 
involved. I acknowledge that I may withdraw from the study at any time without any consequences. 

 
 
 
 
 
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Study Title 
Personalised and gamification-based Decision Aid (DA): a randomized controlled pilot study about 
colorectal cancer (CRC) screening. 
NCT Number 
NCT ID not yet assigned 
Protocol Date 
March 28, 2024 
 
 

 
 
 
 
 
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Information Notice on the Processing of Personal Data pursuant to Articles 13 and 14 of Regulation 
(EU) 2016/679 
 
Pursuant to Article 13 of Regulation (EU) 2016/679 and in compliance with the principle of transparency, the 
following information is provided to ensure that you are fully informed about the nature and methods of 
personal data processing for the purpose of participation in the research project : “Personalised and 
gamification-based Decision Aid (DA): a randomized controlled pilot study about colorectal cancer (CRC) 
screening” carried out by the University of Pavia in collaboration with the Brescia LHA. 
 
 
The general objective of the study is to evaluate the impact of a mobile application on informed decision-
making regarding participation in colorectal cancer screening among individuals residing in the Brescia LHA 
area who will receive their first invitation to undergo a faecal occult blood test (FOBT). 
Secondary objectives concern the impact of the use of the application on screening adherence rates, the 
assessment of decision-making conflict, customer satisfaction and acceptability of the smartphone application, 
as well as its ability to effectively convey information on primary prevention and healthy lifestyles. The study 
characteristics and procedures are described in detail in the document “Information sheet and declaration of 
consent to participate”. 
 
The University of Pavia (hereinafter, “University”), as Data Controller, will process your personal data only 
to the extent strictly necessary to achieve the study’s objectives and in compliance with applicable data 
protection legislation, including Regulation (EU) 2016/679 (General Data Protection Regulation), Legislative 
Decree No. 196 of 30 June 2003 as amended (Italian Data Protection Code), and all applicable provisions and 
guidelines issued by the Italian Data Protection Authority (Garante per la Protezione dei Dati Personali). 
 
 
 
a) Data Controller and contact details 
The Data Controller is the University of Pavia, represented by the Rector pro tempore, with registered office 
at C.so Strada Nuova 65, IT-27100 Pavia, Italy. PEC: amministrazione-centrale@certunipv.it 
b) Data Protection Officer (DPO) contact details 
The Data Protection Officer (DPO) can be contacted at the following email address: privacy@unipv.it 
 
c) Purpose of processing and legal basis 
The University of Pavia is a public institution of higher education and research, entrusted with institutional 
tasks aimed at pursuing educational and scientific objectives (Article 1 of the Statute of the University of 
Pavia), in implementation of Article 33 of the Italian Constitution. 
The University will process personal data for research purposes related to the project “Personalised and 
gamification-based Decision Aid (DA): a randomized controlled pilot study about colorectal cancer (CRC) 
screening” on the basis of agreements with the Brescia LHA. 
 
The University of Pavia processes personal data following the acquisition of the explicit and unambiguous 
consent of the data subject for the processing of personal data pursuant to Article 6(1)(a) of Regulation (EU) 
2016/679, in accordance with the provisions set out in the Ethical Rules for the processing of personal data for 
statistical or scientific research purposes. 
The project complies with the provisions set out in Article 6 of the Ethical Rules for the processing of personal 
data for statistical or scientific research purposes. 
The research is carried out on the basis of a protocol drafted in accordance with the methodological standards 
of the relevant scientific disciplines, in order to demonstrate that the processing of personal data is performed 
for appropriate and legitimate statistical or scientific purposes. When processing health-related data, all parties 
involved comply with the confidentiality and security obligations applicable to healthcare professionals or with 
equivalent confidentiality and security standards. 
The research complies with Article 6 of the aforementioned Ethical Rules. 
It is conducted according to a protocol drafted in compliance with the methodological standards of the relevant 
scientific fields to ensure that personal data processing serves appropriate and effective statistical or scientific 

 
 
 
 
 
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purposes. When processing health-related data, all parties involved must comply with the confidentiality and 
security obligations applicable to healthcare professionals or equivalent standards. 
 
d) Types of data processed 
If the data subject gives their consent to participate in the study, certain personal data concerning them will be 
collected using electronic tools (in particular, the data will be collected through an electronic Case Report 
Form, or “eCRF”). The application used for the study will identify the data subject by means of a unique code. 
 
The personal data collected and processed for the purposes indicated above include: 
- 
Socio-demographic information and psychological characteristics, as well as data related to risk 
perception, knowledge, attitudes, and intention to participate in colorectal cancer screening programs. 
To ensure data quality and accuracy, all questions must be answered; however, participants may stop 
completing the questionnaire and withdraw from the study at any time. Results will always be presented in 
aggregated form. 
 
e) Provision of data 
Participation in the research is entirely free and voluntary, and refusal to participate will have no 
consequences for the data subject.  
Participation in the project by the data subject implies the provision of the personal data requested, as described 
in section (d) of this information notice. Failure to provide the required data or to participate in the research 
project will make it impossible to carry out the project and the related activities. 
f) Methods of processing 
The processing of personal data will be carried out using IT and telematic tools designed to ensure the security 
and confidentiality of the data. 
The University of Pavia, in agreement with the Brescia LHA, has decided to administer the questionnaires to 
the following cohort: 
 
• 
Citizens, both male and female, born between 1 January 1973 and 31 December 1974, who turned 50 
years of age in 2023 or will turn 50 in 2024, thereby entering the national colorectal cancer screening 
program; 
• 
Residents in the Brescia LHA area; 
• 
Individuals who have given their consent to participate in the study. 
 
The data and information will be collected through an application specifically selected by the University, also 
based on its security profile. The University will process the data in a pseudonymized form, identifying each 
participant using a barcode printed on the invitation letter sent by the Brescia LHA. Only the Brescia LHA 
will be able to link the barcode to the participants’ names. The analysis results will subsequently be transmitted 
to the Brescia LHA in anonymous form. 
To achieve the purposes described above, the data will be processed by persons authorized to handle personal 
data under the responsibility of the Data Controller, who have been properly instructed and trained for this 
purpose. 
g) External data processors 
In light of the activities described above, the application provider – that is, the provider of the service necessary 
for the implementation of the study and solely responsible for managing the technical data required for the 
functioning of the application — will act as an External Data Processor pursuant to Article 28 of the GDPR, 
under a specific agreement with the University of Pavia. 
 
Upon completion of the study, the anonymized data will be stored by the University of Pavia for a period of 
five years. 
h) Categories of recipients of personal data 

 
 
 
 
 
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The Data Controller pays particular attention to defining the organizational structure and identifying the 
personnel responsible for data collection, providing them with appropriate instructions regarding the 
procedures for carrying out data processing activities. This is done to ensure compliance with ethical rules and 
to safeguard the rights of the data subjects. 
 
i) Data transfer to third countries 
The University undertakes to limit the scope of circulation and processing of personal data collected in 
connection with the research project (e.g., storage, archiving, and retention of data on its own servers or in the 
cloud) to countries that are part of the European Union. 
j) Data retention period 
Personal data will be retained only for the time strictly necessary to achieve the purposes of the processing (in 
compliance with the principles of necessity and purpose limitation) and will therefore be deleted after five 
years. 
k) Data subject rights 
Data subjects may exercise their rights regarding their personal data, as provided for in Article 15 et seq. of 
Regulation (EU) 2016/679, where applicable, free of charge by submitting a specific request with the subject 
line “Privacy Rights” to the email address indicated above, with a copy to the Scientific Project Lead. 
 
Pursuant to Article 7(3) of Regulation (EU) 2016/679, data subjects have the right to withdraw their previously 
given consent at any time and to exercise the right to the erasure of their personal data, in accordance with 
Article 17 of Regulation (EU) 2016/679 (GDPR). 
Withdrawal of consent shall not affect the lawfulness of processing based on consent prior to its withdrawal. 
 
l) Complaints 
Data subjects have the right to lodge a complaint with the supervisory authority and may contact the Italian 
Data Protection Authority: https://www.garanteprivacy.it/ 
 
 
 

 
 
 
 
 
5 
 
m) Profiling 
The Data Controller does not use any automated decision-making processes for profiling purposes. 
 
By acknowledging the information provided above, participation in the study implies that the 
individual: 
• 
has read and understood this information notice on the processing of personal data and freely 
and voluntarily agrees to take part in the research; 
• 
gives their consent to the processing of their personal data for the purposes and according to the 
procedures described in this information notice.